Fluid transfer device with integrated flow-based assay and methods of use thereof

Abstract

A system includes a fluid transfer device and a lateral flow measurement device. The fluid transfer device has an inlet fluidly coupled to a source of bodily fluid, an outlet fluidly coupled to a sample reservoir, and an isolation chamber configured to receive an initial volume of bodily fluid. The fluid transfer device is switchable between (1) a first state, (2) a second state, and (3) a third state, in which the isolation chamber is fluidly connected to the inlet to receive the initial volume; in the second state, the outlet is fluidly connected to the inlet to receive a subsequent flow of bodily fluid; and in the third state, the lateral flow measurement device is fluidly connected to the isolation chamber to receive a portion of the initial volume of bodily fluid. The lateral flow measurement device is configured to provide an indication associated with the presence of a target analyte in the bodily fluid.

Description

[0001] Cross-references to related applications

[0002] This application claims priority and benefit to U.S. Provisional Patent Application Serial No. 62 / 946,680, filed December 11, 2019, entitled “Fluid Transfer Devices with Integrated Flow-Based Assay and Methods of Using the Same,” the disclosure of which is incorporated herein by reference in its entirety. Technical Background

[0003] The implementation schemes described herein generally relate to the acquisition of body fluid samples and point-of-care diagnostic testing, and more specifically to body fluid delivery devices with integrated flow-based assay systems, such as lateral flow assays that allow for initial point-of-care diagnostic testing.

[0004] Healthcare practitioners use parenteral fluids to perform various types of microbiological diagnostic tests and other extensive diagnostic tests on patients. In some cases, effective treatment for serious patient conditions may be time-dependent, and delays in treatment can lead to an increased risk of morbidity and / or mortality. For example, sepsis is a serious patient illness usually caused by bacterial infections (or less commonly, fungal or viral infections). Sepsis is an unusual systemic response to an infection that would otherwise be a common one, and may represent a pattern of immune system response to damage. A period of high inflammatory response is usually followed by immunosuppression, during which multiple organ dysfunction occurs and patients are susceptible to hospital-acquired infections. Patients with sepsis typically present with malaise, fever, chills, and leukocytosis, which may prompt a physician to evaluate the presence of bacteria in the bloodstream of such patients—usually through bacterial culture tests.

[0005] With the development and improvement of bacterial culture tests and / or other advanced diagnostic technologies, the speed, accuracy (sensitivity and specificity), and value of information available to clinicians are constantly increasing. Examples of such diagnostic technologies include, for example, microbial detection, molecular diagnostics, gene sequencing (e.g., deoxyribonucleic acid (DNA), ribonucleic acid (RNA), next-generation sequencing (NGS), etc.), biomarker identification, etc. Some known culture methods and / or other diagnostic technologies can be susceptible to contamination, which can produce inaccurate, distorted, adulterated, false positives, false negatives, and / or results that do not represent the patient's actual condition (or in vivo status). These results, in turn, can lead to erroneous, inaccurate, confusing, uncertain, low-confidence, and / or otherwise undesirable clinical decisions. In some cases, contamination may be caused by the presence of biological material, including cells and / or other external contaminants outside the intended sample source, which are unintentionally included in the body fluid sample being analyzed. Some known devices and / or systems can be used to reduce the likelihood of contamination and / or adulteration in body fluid samples used for testing, which can reduce the likelihood of inaccurate or erroneous diagnostic test results and lead to better patient outcomes. For example, some known devices can be designed to transfer and isolate an initial volume of bodily fluids, which are more likely to contain contaminants.

[0006] While such diagnostic techniques can provide highly sensitive and / or specific information from tests using clean or unadulterated bodily fluids, the tests typically take 6 hours to approximately 5 days or longer to produce results. Furthermore, known diagnostic techniques generally utilize systems requiring highly trained personnel and / or often employing specially tailored culture protocols to identify a wide variety of bacterial species. Therefore, such culture methods and / or diagnostic techniques are not suitable for the rapid diagnosis and / or efficient screening that may be necessary for treating certain rapidly progressing diseases. For example, sepsis can rapidly progress to multiple organ dysfunction and / or death, prompting physicians to prescribe treatment (e.g., antibiotics) before receiving diagnostic test results.

[0007] Therefore, there is a need for rapid testing of body fluids (e.g., point-of-care diagnostic tests using lateral flow assays or other rapid diagnostic techniques). Additionally, there is a need to integrate rapid tests (e.g., lateral flow assays) into devices that can be used to obtain additional body fluid samples from a patient, e.g., devices configured to obtain body fluid samples with reduced contamination. Summary of the Invention

[0008] The embodiments and methods described herein relate to a body fluid delivery device having an integrated flow-based assay (e.g., lateral flow assay) that allows for initial point-of-care diagnostic testing. In some embodiments, the system includes a flow-based assay device and a fluid delivery device. The fluid delivery device has an inlet configured to be placed in fluid communication with a body fluid source and an outlet configured to be placed in fluid communication with a sample reservoir. The fluid delivery device includes an isolation chamber and a port selectively communicating with the isolation chamber. The isolation chamber is configured to be placed in fluid communication with the inlet to receive a first volume of body fluid when the fluid delivery device is in a first state. The outlet is configured to be placed in fluid communication with the inlet to receive a second volume of body fluid when the fluid delivery device is in a second state. The flow-based assay device is configured to be coupled to the port to receive a portion of the first volume of body fluid when the fluid delivery device is in a third state. The flow-based assay device is configured to provide an indication related to the presence of a target analyte in a portion of the first volume of body fluid. Attached Figure Description

[0009] Figure 1 This is a schematic diagram of the fluid transfer and measurement system according to the implementation plan.

[0010] Figure 2 This is a schematic diagram of the lateral flow measurement device according to the implementation plan.

[0011] Figure 3 This is a schematic diagram of the fluid transfer and measurement system according to the implementation plan.

[0012] Figure 4 This is a schematic diagram of the fluid transfer and measurement system according to the implementation plan.

[0013] Figure 5A and Figure 5B These are schematic diagrams of the fluid transfer and measurement system in the first and second states according to the implementation plan.

[0014] Figures 6A to 6D It is a schematic diagram of at least a portion of the fluid transport and measurement system in the first, second, third and fourth states according to the implementation scheme.

[0015] 7A to 7D It is a schematic diagram of at least a portion of the fluid transport and measurement system in the first, second, third and fourth states according to the implementation scheme.

[0016] Figure 8 It is a perspective view of the fluid transfer and measurement apparatus (or system) according to the implementation plan.

[0017] Figures 9A to 9DThese are cross-sectional views of the fluid transfer and measurement apparatus (or system) of Figure 12, shown in the first, second, third, and fourth states, respectively.

[0018] Figure 10 It is a perspective view of the fluid transfer and measurement apparatus (or system) according to the implementation plan.

[0019] Figure 11 yes Figure 10 A side view of a fluid transfer and measurement device (or system), the housing of which is partially transparent to show the internal features of the device.

[0020] Figure 12A and Figure 12B It is in the first state. Figure 11 A side view of a fluid transfer and measurement device (or system).

[0021] Figure 12C It is in the second state. Figure 11 A side view of a fluid transfer and measurement device (or system).

[0022] Figure 12D It is in the third state. Figure 11 A side perspective view of a fluid transfer and measurement device (or system).

[0023] Figures 13 to 16 These are various views of the fluid transfer and measurement apparatus (or system) according to the implementation plan.

[0024] Figures 17 to 20 These are various views of fluid transfer and measurement devices (or systems) according to different implementation schemes. Detailed Implementation Plan

[0025] Any fluid transfer device described herein can be configured to receive, acquire, and / or transfer the flow, injection, volume, etc., of bodily fluids. Additionally, any fluid transfer device described herein may include an integrated device for performing one or more rapid diagnostic tests on at least a portion of the bodily fluid acquired via the fluid transfer device. In some embodiments, the fluid transfer device may be a syringe, a transfer adapter, and / or any other device configured to receive a flow of bodily fluid. In some embodiments, the fluid transfer device may be a fluid diversion and / or isolation device configured to receive an initial volume of bodily fluid and isolate it from subsequent sampling volumes, such as those used in culture tests. In such embodiments, the integrated device for rapid diagnostic testing may be configured to receive at least a portion of the initial bodily fluid volume or at least a portion of the subsequent sampling volume. The integrated device for rapid diagnostic testing may be, for example, a lateral flow assay and / or any other suitable diagnostic testing device. The integrated device for rapid diagnostic testing can be used to test the quantity of bodily fluid and provide at least a qualitative result, which may be output on or by a device used for visual examination. In other cases, the testing device can transmit data associated with the results to an electronic device (e.g., via a wired or wireless network), which can then perform any suitable analysis on the data and can, for example, graphically represent at least some of the data (e.g., qualitative or quantitative test results) on the device's display.

[0026] In some embodiments, rapid diagnostic testing devices may be included or integrated into fluid delivery devices (e.g., sample collection devices) and used to provide initial test results of the acquired body fluids. The initial test results can be supplemented by additional tests of the acquired body fluids, such as culture tests. For example, an integrated rapid diagnostic testing device (also referred to herein as a “rapid testing device” or “initial testing device”) can provide a relatively rapid method for testing the presence of microorganisms (e.g., Gram-positive bacteria, Gram-negative bacteria, fungi, or viruses) or other types of biological substances (e.g., specific types of cells, biomarkers, proteins, antigens, enzymes, blood components, etc.) in body fluids, the presence of which can inform clinicians in making decisions regarding treatment strategies. In some embodiments, the initial testing device can test for bacteria and / or other infections that can cause and / or otherwise lead to sepsis, thereby allowing clinicians to provide rapid treatment, such as broad-spectrum antibiotics. Furthermore, the fluid transport device described herein can acquire additional sampling volumes, which can be used for more sensitive tests (such as culture tests) or other techniques, such as molecular polymerase chain reaction (PCR), magnetic resonance and other magnetic analysis platforms, automated microscopy, spatial clonal isolation, flow cytometry, whole blood (“culture-free”) sample analysis (e.g., NGS) and related techniques, morphodynamic cell analysis and / or other common, advanced or developing techniques for characterizing patient samples and / or for detecting, identifying, typing, classifying and / or characterizing specific organisms, antibiotic sensitivity, etc.

[0027] In some embodiments, the system includes a flow-based measuring device and a fluid transfer device. The fluid transfer device has an inlet configured to be in fluid communication with a source of bodily fluid and an outlet configured to be in fluid communication with a sample reservoir. The fluid transfer device includes an isolation chamber and a port selectively communicating with the isolation chamber. The isolation chamber is configured to be in fluid communication with the inlet to receive a first volume of bodily fluid when the fluid transfer device is in a first state. The outlet is configured to be in fluid communication with the inlet to receive a second volume of bodily fluid when the fluid transfer device is in a second state. The flow-based measuring device is configured to be coupled to the port to receive a portion of the first volume of bodily fluid when the fluid transfer device is in a third state. The flow-based measuring device is configured to provide an indication related to the presence of a target analyte in a portion of the first volume of bodily fluid.

[0028] In some embodiments, the system includes a fluid transfer device having an inlet configured to receive a flow of bodily fluid from a source, an outlet configured to be placed in fluid communication with a sample reservoir, an isolation chamber configured to receive a first volume of bodily fluid, and a port in at least temporary fluid communication with the isolation chamber. The fluid transfer device is configured to switch between a first state and a second state, in which the isolation chamber is in fluid communication with the inlet to receive the first volume of bodily fluid, and in a second state, the outlet is in fluid communication with the inlet to receive a second volume of bodily fluid. When the isolation chamber receives the first volume of bodily fluid, the port of the isolation chamber allows gas flow through the isolation chamber. A flow-based assay device is configured to be coupled to the fluid transfer device in the second state. When coupled to the fluid transfer device, a portion of the flow-based assay device engages with the port to allow a portion of the first volume of bodily fluid to be transferred from the isolation chamber to the flow-based assay device. The flow-based assay device is configured to provide an indication related to the presence of a target analyte in the initial volume of bodily fluid.

[0029] In some embodiments, the method includes configuring an inlet of a fluid transfer device in fluid communication with a source of bodily fluid, receiving a first volume of bodily fluid from the inlet and directing it into an isolation chamber of the fluid transfer device, wherein during reception, a flow controller of the fluid transfer device allows gas to flow through the flow controller but does not allow bodily fluid to flow through the flow controller, thereby ventilating the isolation chamber. After the first volume of bodily fluid has been received in the isolation chamber, the fluid transfer device is switched from a first state to a second state. In response to the fluid transfer device being in the second state: fluid communication is established between the inlet and outlet of the fluid transfer device to allow a second volume of bodily fluid to flow into a sample reservoir in fluid communication with the outlet. A portion of the first volume of bodily fluid is delivered from the isolation chamber to a sampling element of a flow-based assay device, which is at least temporarily fluidly coupled to the isolation chamber; and a buffer solution is delivered to the sampling element of the flow-based assay device.

[0030] In some embodiments, the system includes a fluid transfer device and a lateral flow measurement device. The fluid transfer device includes an inlet configured to be in fluid communication with a source of bodily fluid, an outlet configured to be in fluid communication with a sample reservoir, and an isolation chamber configured to receive an initial volume of bodily fluid. The fluid transfer device is configured to switch between (1) a first state, (2) a second state, and (3) a third state, in which, in the first state, the isolation chamber is in fluid communication with the inlet to receive the initial volume of bodily fluid; in the second state, the outlet is in fluid communication with the inlet to receive a subsequent flow of bodily fluid; and in the third state, the lateral flow measurement device is coupled to a port in fluid communication with the isolation chamber. The lateral flow measurement device is configured to receive a portion of the initial volume of bodily fluid and determine the presence of a target analyte in the initial volume of bodily fluid.

[0031] As used in this specification and / or any of the claims included herein, unless the context clearly specifies otherwise, the singular forms “a,” “an,” and “the” include plural indicators. Thus, for example, the term “a component” is intended to mean a single component or a combination of components, “a material” is intended to mean one or more materials, and so on.

[0032] As used herein, “body fluid” can include any fluid obtained directly or indirectly from the patient’s body. For example, “body fluid” includes, but is not limited to, blood, cerebrospinal fluid, urine, bile, lymph, saliva, synovial fluid, serous fluid, pleural fluid, amniotic fluid, mucus, sputum, vitreous fluid, air, or any combination thereof.

[0033] As used herein, the terms “proximal” and “distal” refer to the direction closer to and further away from the user who places the device in contact with the patient, respectively. Thus, for example, the end of the device that first contacts the patient’s body would be the distal end of the device, while the opposite end of the device (e.g., the end of the device operated by the user) would be the proximal end of the device.

[0034] As used herein, the terms “about,” “approximately,” and / or “substantially,” when used in conjunction with one or more of the stated values ​​and / or one or more geometries or one or more relationships, are intended to convey that the value or characteristic so defined is nominally the stated value or characteristic. In some cases, the terms “about,” “approximately,” and / or “substantially” may generally indicate and / or may generally be expected within a desired tolerance (e.g., ±10% of the stated value or characteristic). For example, a value approximately 0.01 may include 0.009 and 0.011, a value approximately 0.5 may include 0.45 and 0.55, a value approximately 10 may include 9 to 11, and a value approximately 100 may include 90 to 110. Similarly, when surfaces are nominally parallel, a first surface may be described as substantially parallel to a second surface. While the stated values, structures, and / or relationships may be desirable, it should be understood that variations may occur due to, for example, manufacturing tolerances or other practical considerations (such as pressure or force applied through a part of a device, conduit, lumen, etc.). Therefore, the terms “about,” “approximately,” and / or “substantially” are used herein to describe such tolerances and / or considerations.

[0035] As used herein, the terms “first,” “initial,” and / or “pre-sampling” are used interchangeably to describe the volume, fraction, or amount of bodily fluid collected, diverted, isolated, tested, etc., prior to obtaining a “sample” volume. The “first,” “initial,” and / or “pre-sampling” volume can be a predetermined, defined, desired, and / or given amount of bodily fluid. For example, the predetermined and / or required pre-sampling volume of bodily fluids such as blood can be one drop of blood, a few drops of blood, about 0.1 mL, about 0.2 mL, about 0.3 mL, about 0.4 mL, about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, about 1.0 mL, about 2.0 mL, about 3.0 mL, about 4.0 mL, about 5.0 mL, about 6.0 mL, about 7.0 mL, about 8.0 mL, about 9.0 mL, about 10.0 mL, about 20.0 mL, about 50.0 mL, and / or any volume or volume fraction between these values. In other cases, the pre-sampling volume can be greater than 50 mL or less than 0.1 mL. As a specific example, the predetermined and / or required pre-sampling volume can be between about 0.1 mL and about 5.0 mL. As another example, the pre-sampling volume can be, for example, the volume of any number of lumens or a combination of lumens (e.g., the lumen of a needle and / or a combination of lumens that form at least a portion of the flow path from the source of body fluid to the initial collection chamber, section, reservoir, etc.). As yet another example, the pre-sampling volume can be, for example, a volume of body fluid sufficient for initial testing or pre-sampling testing (e.g., rapid diagnostic testing using lateral flow measurement and / or any other rapid testing device).

[0036] As used herein, the terms “second,” “subsequent,” and / or “sampling” are used interchangeably to describe the volume, fraction, or volume of body fluid collected after the collection of the first, initial, and / or pre-sampling volume of body fluid. The “second,” “subsequent,” and / or “sampling” volume can be a random, predetermined, or desired volume of body fluid collected after the collection, diversion, isolation, and / or testing of the pre-sampling volume of body fluid. In some cases, the desired sampling volume of body fluid can be from about 10 mL to about 60 mL. In other cases, the desired sampling volume of body fluid can be less than 10 mL or greater than 60 mL. In still other cases, the desired sampling volume can be at least in part based on one or more tests, determinations, analyses, and / or treatments to be performed on the sampling volume.

[0037] In some implementations, second, subsequent, and / or sampling volumes of body fluid can be used for one or more samples or diagnostic tests, such as culture tests. In some cases, collecting a "sampling" volume of body fluid after collecting, isolating, separating, and / or testing a "pre-sampling" volume may result in a lower likelihood that the sample volume contains contaminants such as skin-resident microorganisms. Therefore, the sampling volume of body fluid can be used for sensitive tests that would otherwise be prone to inaccurate results due to contamination.

[0038] The embodiments described herein and / or portions thereof may be formed or constructed from one or more biocompatible materials. In some embodiments, biocompatible materials may be selected based on one or more properties of the constituent materials, such as stiffness, toughness, hardness, bioactivity, etc. Examples of suitable biocompatible materials include metals, glass, ceramics, or polymers. Examples of suitable metals include pharmaceutical-grade stainless steel, gold, titanium, nickel, iron, platinum, tin, chromium, copper, and / or alloys thereof. Polymer materials may be biodegradable or non-biodegradable. Examples of suitable biodegradable polymers include polylactide, polyglycolic acid, polylactide-co-glycolic acid (PLGA), polyanhydride, polyorthoester, polyether ester, polycaprolactone, polyesteramide, poly(butyric acid), poly(valeric acid), polyurethane, and / or blends and copolymers thereof. Examples of non-biodegradable polymers include nylon, polyester, polycarbonate, polyacrylate, polysiloxane (silicone), ethylene-vinyl acetate and other acyl-substituted cellulose acetate polymers, non-biodegradable polyurethane, polystyrene, polyvinyl chloride, polyvinyl fluoride, poly(vinylimidazolium), chlorosulfonated polyolefins, polyethylene oxide and / or their blends and copolymers.

[0039] Now refer to the attached diagram, Figure 1 This is a schematic diagram of a fluid transport and measurement system 100 according to an embodiment. While various components, elements, characteristics, and / or functions may be described below, it should be understood that they are presented by way of example only and not limitation. Those skilled in the art will understand that, as described herein, the form and / or characteristics of the fluid transport and measurement system 100 can be modified without altering its ability to perform the functions of acquiring bodily fluid samples and providing rapid diagnostic testing methods.

[0040] The fluid transfer and measurement system 100 (also referred to herein as the “system”) may include at least a fluid transfer device 105 and a rapid diagnostic testing device 170. In some embodiments, the system 100 may optionally include at least one electronic device 190 and / or at least one fluid collection device 195.

[0041] The fluid transfer device 105 (also referred to herein as the “transfer device”) may have any suitable shape, size, and / or configuration as described herein with reference to specific embodiments. In some embodiments, the transfer device 105 may be configured to draw bodily fluids (e.g., blood) from a patient and transfer them into the transfer device 105. Additionally, the transfer device 105 may be configured to transfer at least some of the drawn bodily fluids to one or more other devices, reservoirs, containers, vials, machines, tests, assays, etc., such as the rapid diagnostic testing device 170 and / or one or more optional fluid collection devices 195.

[0042] In some embodiments, the transfer device 105 may be configured to transfer, direct, and / or redirect a quantity or volume of bodily fluid to (or through) one or more portions of the transfer device 105, and subsequently transfer these quantities or volumes to one or more devices coupled to or integrated with the transfer device 105, to one or more sample reservoirs, containers, bottles, etc. For example, the transfer device 105 may be configured to transfer a first fraction, quantity, or volume of bodily fluid to or through a first or isolation portion of the transfer device 105, and subsequently transfer a second fraction, quantity, or volume (e.g., a subsequent quantity) of bodily fluid to a second or sampling portion of the transfer device 105. In some embodiments, the transfer device 105 and / or the isolation portion of the transfer device 105 may be configured to isolate the first quantity of bodily fluid (e.g., within the isolation portion of the transfer device 105) from subsequent quantities of bodily fluid, as described in further detail herein with reference to specific embodiments. In some embodiments, the transfer device 105 may be configured to transfer at least some first amount of bodily fluid (e.g., contained in an isolation portion of the transfer device 105) to the rapid diagnostic test device 170 and at least some second amount of bodily fluid to one or more optional fluid collection devices 195.

[0043] The rapid diagnostic test device 170 (also referred to herein as the “rapid test device” or simply the “test device”) may have any suitable shape, size, and / or configuration as described herein with reference to specific embodiments. In some embodiments, the rapid test device 170 may be removably coupled to the transmission device 105 or any suitable portion thereof (e.g., inlet portion, outlet portion, isolation portion, sampling portion, and / or any other suitable portion). In other embodiments, the rapid test device 170 may be integrated into the transmission device 105. For example, the transmission device 105 and the rapid test device 170 may be integrally or singly formed and / or otherwise integrated. In other embodiments, the transmission device 105 may include and / or may form ports, adapters, and / or receiving portions to which the rapid test device 170 may be coupled, or the rapid test device 170 may be inserted into the ports, adapters, and / or receiving portions to establish fluid communication therebetween. In some such implementations, coupling the rapid test device 170 to the transmission device 105 can be used to switch one or more flow controllers, valves, diaphragms, ports, seals, etc., from a closed or sealed state to an open state to allow fluid communication between the transmission device 105 and the test device 170.

[0044] In some embodiments, the rapid testing device 170 may be configured to receive a first volume of bodily fluid from the delivery device 105 and use the first volume of bodily fluid to perform one or more tests, assays, and / or diagnostic procedures. For example, the rapid testing device 170 may be a chromatographic lateral flow immunoassay, which can test for any suitable analyte, biomarker, protein, molecule, particle, etc. Chromatographic lateral flow immunoassays (referred to herein as “lateral flow assays” or “LFAs”) are typically nitrocellulose-based devices configured to detect the presence of a target analyte in a sample (e.g., a biological sample and / or a bodily fluid sample, such as blood, urine, etc.). Generally, an LFA comprises a series of capillary beds, such as porous paper sheets, microstructured or sintered polymers, etc., which may be disposed in desired locations and / or arrangements on a substrate to guide the sample (e.g., at least some of a first quantity of bodily fluid) to flow along a portion of the LFA.

[0045] LFA can be used in a wide range of applications where a relatively rapid, easy-to-use, and low-cost method is desired for rapid antigen detection. LFA is typically performed with little or no sample or reagent preparation, which can yield usable test results in as little as a few minutes (or longer if more sensitive test results are required). Furthermore, in some embodiments, LFA can be configured to test for analytes and / or biomarkers produced by the human body in response to in vivo conditions (e.g., infections such as sepsis), which again means that such LFA has relatively low sensitivity to contaminants (e.g., skin-residing microorganisms, etc.) that may be contained in a first quantity of bodily fluids drawn from the patient via the delivery device 105.

[0046] Typically, two types of LFAs are used, depending on the size and / or number of binding sites on the target analyte. Specifically, competitive LFAs are generally used when testing smaller analytes, while sandwich LFAs are generally used when testing larger analytes. In the context of home pregnancy testing, sandwich lateral flow assays are well-known. In some cases, sandwich LFAs may be needed to test for antigens, analytes, and / or biomarkers associated with sepsis and / or other infectious conditions in samples such as bodily fluids (e.g., blood). While the embodiments described herein include and / or implement sandwich LFAs, it should be understood that the embodiments are not limited thereto. For example, any embodiment described herein may use and / or perform competitive LFAs and / or any other suitable rapid diagnostic testing device.

[0047] Figure 2 A schematic example of a sandwich LFA 170A for contextual purposes is shown. The sandwich LFA 170A (referred to herein as “LFA”) includes a substrate 171 on which a sampling element 172, a conjugate element 173, a trapping element 174, a control element 175, and a suction core 176 are disposed. The substrate 171 can have any suitable shape, size, and / or configuration. For example, the substrate 171 can be a rectangular backing card or strip having a constant width and predetermined length, providing sufficient surface area to accommodate the various components of the LFA 170A. The substrate 171 may be made of a semi-rigid polymer designed to provide uniformity and flatness. The substrate 171 may contain one or more pressure-sensitive adhesives configured to facilitate the adhesion of the various components of the LFA 170A, as further described herein.

[0048] As shown, sampling element 172 is typically disposed at one end of the substrate and configured to receive a sample volume. Sampling element 172 may be a pad that provides a surface for receiving samples of blood and / or other biological fluids for analysis and facilitates the smooth, continuous, and uniform delivery of the sample to other components of the lateral flow test strip. Sampling element 172 may have any suitable shape, size, and / or configuration. Conjugation element 173 is disposed adjacent to sampling element 172 in a downstream direction. Conjugation element 173 comprises a dried matrix (e.g., a salt-sugar matrix) configured to include desired bioactive particles. The bioactive particles contained in the matrix include specific antibodies and / or affinity reagents (e.g., DNA aptamers, protein binders, etc.) immobilized on or within conjugation element 173. Antibodies and / or affinity reagents may be selected based on the target molecule (e.g., antigen or analyte) configured to be detected by LFA 170A. Alternatively, antibodies and / or affinity reagents may be conjugated directly or indirectly to molecules configured to allow detection. For example, antibodies can be labeled with colored particles (e.g., latex with blue color, colloidal gold with red color, and / or any other suitable particles), fluorescent particles, magnetic particles, enzymes for subsequent signal generation, etc. Thus, the labeled antibody can bind to a desired antigen or analyte to produce a labeled target analyte 177, which can be detected in other parts of the LFA 170A or by other elements of the LFA 170A.

[0049] The capturing element 174 is disposed near and / or downstream of the conjugation element 173 and contains particles or molecules that have been immobilized in or on the capturing element 174. The particles or molecules may be configured to bind to a labeled analyte 177, thereby capturing or immobilizing the labeled analyte 177 in or on the capturing element 174. As the concentration of the captured and / or immobilized labeled analyte 177 increases (e.g., the number of molecules within the capturing element 174 increases), the optical density of the detected molecules (e.g., colored markers) also increases. In this way, the LFA 170A is configured to present discrete colorimetric signal lines, regions, or bars to indicate the presence of the target analyte in the sample volume (e.g., a positive test result).

[0050] Control element 175 is disposed near and / or downstream of capture element 174. Control element 175 contains particles or molecules that have been immobilized within or on control element 175. Unlike capture element 174, the particles or molecules contained in control element 175 can be configured to bind to a variety of different particles, such as labeled analyte 177, labeled bioactive particles not bound to antigen, etc. Thus, control element 175 can be configured to bind and / or otherwise immobilize labeled particles that were not originally immobilized within or on capture element 174. Thus, control element 175 can present a colored portion or band, which can be used to indicate that a reaction has occurred and / or a test has been performed. For example, if the target analyte is not present in the sample volume, it may be desirable to confirm that the assay was performed correctly and that a negative result (no colored band on capture element 174 or capture element 174 not presenting a colored band) indicates the condition of the sample volume, rather than a malfunction of LFA 170A. The wick 176 is positioned near and / or downstream of the control element 175 and is configured to absorb or wick a portion of the sample that is not secured in or above the capture element 174 and / or the control element 175.

[0051] Measurement

[0052] The LFA 170A can be used to test for the presence of any suitable target analyte, biomarker, molecule, particle, etc., in a sample volume (e.g., a blood sample or any other suitable bodily fluid sample). For example, any embodiment described herein may include and / or implement an LFA (e.g., LFA 170A) and / or any other suitable flow-based rapid diagnostic system configured to test for the presence of a specific analyte or biomarker that can provide information for diagnosing a patient condition such as sepsis.

[0053] For example, blood lactate can be a biomarker for the clinical diagnosis and management of sepsis. In some cases, many other biomarkers can serve as alternatives to or supplements to lactate to guide clinical decision-making. A non-exhaustive list of suitable biomarkers may include pro-inflammatory cytokines and / or chemokines associated with the hyper-inflammatory phase of sepsis; C-reactive protein and / or procalcitonin (PCT), synthesized in response to infection and inflammation; biomarkers associated with neutrophil and / or monocyte activation; anti-inflammatory cytokines associated with the immunosuppressive phase of sepsis; and / or alterations in cell surface markers of monocytes and / or lymphocytes. In some cases, combinations of pro-inflammatory and anti-inflammatory biomarkers from multiple LFAs can be used, for example, to identify patients who are developing severe sepsis prior to substantial organ dysfunction. In some cases, one or more aptamers can be synthesized to target specific pro-inflammatory biomarkers, anti-inflammatory biomarkers, and / or any other suitable biomarkers, such as those described herein.

[0054] lactic acid

[0055] In some embodiments, any of the embodiments described herein can be used to detect lactate biomarkers, PCT biomarkers, and / or any other suitable biomarkers described herein that are associated with sepsis and / or otherwise used to identify sepsis. For example, in some embodiments, rapid testing device 170 may be configured to test blood lactate levels in a body fluid (e.g., blood) sample using, for example, a portable blood gas analyzer. In other embodiments, rapid testing device 170 may be an LFA (e.g., LFA 170A) configured to test for blood (e.g., whole blood, serum, etc.) lactate biomarkers (e.g., antigens). For example, the effectiveness of using serum lactate levels to diagnose sepsis is shown in Table 1 below, which presents results of studies on acute in-hospital mortality in sepsis patients on vasopressors (e.g., agents that cause vasoconstriction).

[0056] Table 1:

[0057]

[0058] Lactic acid is the end product of anaerobic glucose breakdown in tissues. It can be broken down into lactate, a hydroxycarboxylic acid anion, which is the conjugate base of lactate produced by the deprotonation of the carboxyl group. Lactic acid formation occurs when the energy needs of tissues cannot be met through adequate aerobic respiration. Lactic acid can be transported from the blood to the liver, where it is converted back to glucose via the Cori cycle. However, if the liver and kidneys cannot adequately clear lactate, the accumulated lactate concentration can lead to lactic acidosis. Clinically, the causes of acidosis can be classified into type A disorders and type B disorders. Type A disorders involve reduced tissue oxygenation, such as in sepsis, while type B disorders are caused by certain drugs and / or toxins, often accompanied by systemic diseases. Medical evidence shows that patients with persistently elevated lactate levels have increased morbidity and mortality. Excessive lactate in the body can also lead to bleeding, respiratory failure, trauma, seizures, local ischemia, kidney problems, liver disease, tissue hypoxia, shock, blood loss, and anemia. Therefore, lactate monitoring is crucial for diagnosing and assessing health problems arising in hypoxic conditions (i.e., situations where lactate levels in the body are elevated above acceptable levels). Blood lactate concentrations in healthy, non-stressed individuals have been reported to range from 0.1 to 1.0 mmol / M. In contrast, severely ill patients, such as those with severe sepsis or septic shock, may exhibit concentrations above 4 mM.

[0059] Lactic acid can exist as one of two optical isomers (L-lactic acid and its mirror image, D-lactic acid). Analytical methods for detecting and quantifying lactic acid include high-performance liquid chromatography (HPLC), fluorescence assays, colorimetric assays, chemiluminescence, and magnetic resonance spectroscopy. While these methods can provide accurate results, they have drawbacks such as time-consuming sample preparation, the use of expensive instruments, and the need for trained personnel. Therefore, the use of these analytical methods for detecting and quantifying lactic acid in biofluids is more suitable for centralized laboratories, and their implementation as point-of-care diagnostic tools may be limited.

[0060] The detection of lactate levels in biofluids, including blood and / or plasma, can also be achieved using enzymes. These enzymes can be immobilized on solid surfaces or supports (e.g., biosensors) to provide reaction sites that catalyze lactate chemistry by stabilizing transition reaction states or lowering the activation energy of specific lactate chemistry reactions, producing one or more types that can be monitored to correlate their evolution with lactate concentration. For example, enzymes such as L-lactate oxidase (LOD) and L-lactate dehydrogenase (LDH) can be used to detect L-lactic acid. LOD is a globular flavoprotein that can be obtained from a variety of bacterial sources such as Pediococcus, Aerococcus, Viridans, and Mycobacterium. The source of LOD can affect the pH range in which the enzyme can exhibit sufficient catalytic activity, typically ranging between 4 and 9. As a member of the flavin mononucleotide (FMN) family, LOD utilizes FMN as a cofactor to catalyze the oxidation of hydroxy acids in its reaction, which involves glycolate oxidase, L-lactic acid, monooxygenase, flavin cytochrome b2, long-chain α-hydroxy acid oxidase, and L-mandelate dehydrogenase. LOD can be immobilized on a solid support and exposed to biological fluids such as blood and plasma for the detection of the presence of L-lactic acid. LOD can catalyze the oxidation of L-lactic acid to pyruvate (PA) in the presence of dissolved oxygen, producing reduced LOD and hydrogen peroxide (H₂O₂) as a byproduct. The hydrogen peroxide produced by lactate oxidation can be precisely quantified by secondary chemical and / or electrochemical reactions. For example, the hydrogen peroxide produced during lactate oxidation in the presence of LOD enzymes can be electrochemically reduced or oxidized, generating an electrical signal that can be monitored by an electrode. The reduced LOD enzyme can then be re-oxidized on the electrode in a second reaction step, as shown in the reaction scheme below:

[0061]

[0062] H₂O₂→O₂+2H₂ + +2e -

[0063] Similar to LOD, LDH enzymes can be used to detect and quantify the presence of L-lactic acid in various biological fluids. LDH is a quaternary protein found in animals, plants, and prokaryotes. LDH is present throughout tissues and is released upon tissue damage. LDH enzymes comprise five distinct isoenzyme forms, distinguished by minor structural differences. Depending on the source, LDH enzymes are known to be stable within a relatively narrow pH range of 5–8, and more specifically, within a pH range of approximately 7.2–7.4. LDH can also catalyze the reaction of L-lactic acid to pyruvate (PA) via its cofactor nicotinamide adenine dinucleotide (NAD), which can be oxidized (NAD) to form pyruvate. + LHD exists in both its oxidized and reduced (NADH) forms. During the reaction, LHD converts L-lactic acid to pyruvate (PA) and NAD+ to its reduced (NADH) form. + It is converted to NADH. Then, the detection of lactate using LDH enzymes can be achieved through a secondary reaction, as described above in the reference section on the detection of L-lactic acid using LDH enzymes. For example, NADH can be electrochemically oxidized under the influence of an applied potential generated by an electrode, with the resulting current proportional to the L-lactic acid concentration, as shown in the following reaction equation:

[0064]

[0065]

[0066] As described above, the detection of lactate in biofluids using enzymes via the enzymatic oxidation of lactate relies on the conversion of lactate into one or more byproducts such as NADH and hydrogen peroxide (H₂O₂), which can be precisely quantified by secondary reactions. These secondary reactions typically involve electrochemical conversions occurring at the electrode surface (e.g., electrochemical techniques for lactate sensing), producing a transient current proportional to the amount of lactate present in the sample. Alternatively, as further described herein, byproducts of the enzymatic reaction of lactate can be quantified by light transfer processes (e.g., electrochemiluminescence and fluorescence techniques for lactate sensing).

[0067] Electrochemical biosensors (i.e., electrochemical biosensors) detect lactate using electrochemical techniques and utilize enzymes immobilized on a supporting substrate located near or adjacent to the electrode surface. The performance characteristics of electrochemical biosensors can vary considerably depending on the enzyme's source, environmental conditions including pH and temperature, the method used to immobilize the enzyme on the biosensor, the chemical properties of the matrix or support used for enzyme immobilization, and / or the electron transfer mechanism. Enzymes can be immobilized using various methods, and their reactivity depends on their interaction with the support, the nature of the enzyme, and the type of adsorption, the presence of mediators, and additives. Common enzyme immobilization techniques include physical adsorption, retention behind dialysis or polymer membranes, covalent coupling via crosslinking agents, and incorporation into the matrix of carbon composite matrices.

[0068] Challenges associated with enzyme immobilization include reproducibility, stability, and inactivation due to the evolution and / or accumulation of inhibitors and / or contaminants. For example, LOD enzymes immobilized by physical adsorption onto biosensors containing Au electrodes exhibit a 50% loss of stability after just one month of storage, while LOD enzymes immobilized in mesoporous silica using a polyvinyl alcohol (PVA) polymer matrix retain 98% of their initial activity after nine months. Therefore, the development of sensors for detecting lactate using LOD enzymes requires determining suitable immobilization techniques, appropriate matrix supports, and usage and / or storage conditions that allow for the long-term maintenance of enzyme activity or shelf life.

[0069] Electrochemical biosensors for lactate detection typically comprise a device with two or three electrode sensing platforms. Accurate measurement of lactate usually involves using a reference electrode (typically made of Ag / AgCl2) held near the working electrode to maintain a stable and known potential. The working electrode acts as a transducer, while the counter electrode establishes a path for current due to the potential change at the working electrode. Common methods for measuring the electrical signal generated during lactate detection include cyclic voltammetry, galvanometry, and potentiometry. Electrochemical biosensors can offer high sensitivity, wide linear range, and rapid response. However, their use is limited by complex experimental setups, system passivation due to fouling agents, and signal attenuation and interference due to competing reactions. For example, the electrochemical quantification of hydrogen peroxide (H₂O₂) generated during the enzymatic oxidation of L-lactic acid by LOD enzymes requires a high oxidation potential, leading to interference from other electrooxidizable substances.

[0070] Lateral flow assays (LFAs) configured to test blood (e.g., whole blood, serum, etc.) for lactate biomarkers (e.g., antigens) offer alternative tools to facilitate and / or aid in the diagnosis of sepsis. (See above reference.) Figure 2As shown, LFA can be performed on a strip comprising one or more components mounted on a plastic backing laminate or substrate 171. Components configured for LFA of lactate in blood and / or other biological fluids may include at least a sampling element 172 and a conjugation element 173.

[0071] Sampling element 172 may be a pad, as described above, providing a surface for receiving samples of blood and / or other biological fluids for analysis and facilitating the smooth, continuous, and uniform delivery of samples to other components of the lateral flow test strip. Sampling element 172 may have any suitable shape and / or size. In some embodiments, sampling element 172 may be a rectangular strip configured to adsorb and receive a volume of blood and / or other biological fluid samples. In other embodiments, sampling element 172 may be a rectangular strip with one end including a region larger than the strip width to facilitate aspiration of a volume of blood and / or other biological fluid samples. For example, sampling element 172 may be a rectangular strip including a circular region attached to one end of the strip. The circular region of sampling element 172 can provide a larger surface area for receiving blood and / or other biological fluid samples via a micropipette. Alternatively, in some embodiments, sampling element 172 may include a large-diameter circular region having various rectangular strips originating from the center of the circular region in the radial direction. Each rectangular strip facilitates the delivery of a portion of blood and / or other biological fluid samples to other components of the sideflow test strip for the simultaneous detection of multiple biomarkers (i.e., multiplexing) and / or for repeated assays for validation purposes.

[0072] Sampling element 172 may be disposed on the surface of the plastic backing stack to provide mechanical support to the LFA. In some embodiments, sampling element 172 may include an adhesive coated on one surface of the sample pad to facilitate adhesion to the plastic backing stack. The shape and size of sampling element 172 may be predetermined so that it can be disposed on the plastic backing stack. The thickness of sampling element 172 may be selected to facilitate adhesion of sampling element 172 to the plastic backing stack while maintaining the mechanical structure of the pad. Furthermore, the thickness of sampling element 172 may be selected to accommodate large amounts of blood and / or other biological fluids, prevent sample oversaturation on the pad, and guide the sample to the plastic backing stack. For example, in some embodiments, the thickness of sampling element 172 may be between 0.18 mm and 0.34 mm.

[0073] Sampling element 172 may be made of cellulose, nitrocellulose, glass fiber, and / or any other suitable material. In some embodiments, sampling element 172 may be made of cellulose membrane and / or chromatography paper configured to promote a linear flow rate of about 3 to 5 mm / min. Sampling element 172 may also include one or more chemical reagents configured to pretreat the sample before delivery to other downstream components. In some embodiments, the surface of sampling element 172 may be impregnated with a buffered aqueous solution providing an environment with a controlled pH. In some embodiments, the surface of the sampling element 172 may be impregnated with a buffer solution, including but not limited to phosphate-buffered saline (PBS), 2-ethanesulfonic acid (MES), tris(hydroxymethyl)aminomethane (TRIS), piperazine-N,N′-bis(PIPES), 3-morpholinopropane-1-sulfonic acid (MOPS), 2-[4-(2-hydroxyethyl)piperazine-1-yl]ethanesulfonic acid (HEPES), [tris(hydroxymethyl)methylamino]propanesulfonic acid (TAPS), N-cyclohexyl-2-aminoethanesulfonic acid (CHES), and / or N-cyclohexyl-3-aminopropanesulfonic acid (CAPS).

[0074] In some embodiments, sampling element 172 may include one or more components configured to capture and separate species present in blood and / or other biofluids that could interfere with LFA assays. For example, in some embodiments, sampling element 172 may include one or more regions configured to separate red blood cells present in blood and / or other biofluid samples. In some cases, the one or more regions configured to separate blood cells may be one or more separation pads disposed on sampling element 172. In other embodiments, the blood separation region may be a pad located in proximity to sampling element 172. In some cases, the blood separation pad may include one or more layers, such as polyester matrix and composite matrix, designed with an asymmetric morphology of different porosities and pore size distributions, which facilitates the capture of cellular components of blood (i.e., red blood cells, white blood cells, and platelets) in larger pores while allowing plasma to flow downstream through smaller pores.

[0075] The conjugation element 173 of the LFA for detecting and quantifying lactate from blood and / or other biological fluid samples may be a pad located downstream of the sampling element 172. The conjugation element 173 may comprise a dried matrix (e.g., a salt-sugar matrix) comprising bioactive species that can react with lactate and produce species detectable by colorimetry, as further described herein. The conjugation element 173 may be configured to contain one or more bioactive species that can be released upon contact with a moving liquid sample deposited on the upstream sampling element 172. As described above with reference to the sampling element 172, the conjugation element 173 may be a pad having any suitable shape and / or size. In some embodiments, the shape of the conjugation element 173 may be a strip having a size and / or shape substantially similar to that of the sampling element 172. In some embodiments, the conjugation element 173 and the sampling element 172 may be made from a single pad and may be disposed at opposite ends thereto and optionally attached to the surface of a plastic backing laminate to provide mechanical support to the LFA. In yet another embodiment, the conjugation element 173 and the sampling element 171 may be made of a single pad comprising a rectangular strip, wherein a first end of the strip includes a region larger than the strip width to provide a region for accommodating bioactive species for lactate oxidation and colorimetric detection, and a second end opposite the first end of the strip is larger than the strip width to provide a region for accommodating a volume of blood and / or other biological fluid sample. Alternatively, in some embodiments, the conjugation element 173 may comprise a plurality of rectangular strips radially coupled to a large-diameter circular region configured to accommodate the sampling element 171. In this configuration, each conjugation element 173 may facilitate the detection of multiple biomarkers present in a portion of a blood and / or other biological fluid sample (i.e., multiplexing), and / or be used for repeated assays for validation purposes.

[0076] The conjugation element 173 may include a dried matrix configured to include desired bioactive species for detecting and quantifying lactate in blood and / or other biofluid samples. For example, in this embodiment, the matrix of the conjugation element 173 may include a detection enzyme and a quantifying enzyme. The detection enzyme may be configured to exhibit high activity and selectivity for the catalytic oxidation of lactate, producing one or more byproducts that can be monitored by secondary chemical reactions to quantify the concentration of lactate present in the sample. For example, in some embodiments, the matrix of the conjugation element 173 may include a detection enzyme such as L-lactate oxidase (LOD). In other embodiments, the matrix of the conjugation element 173 may include other suitable detection enzymes such as L-lactate dehydrogenase (LDH). One or more detection enzymes may be loosely deposited on the surface of the conjugation element 173 pad such that they can dissolve in a volume of blood and / or other biofluid sample flowing from the sampling element 172.

[0077] Quantitative enzymes can be configured to exhibit high activity and selectivity for one or more types of stoichiometric conversions generated during the enzymatic oxidation of lactate, producing a quantifiable signal. In some embodiments, the dried matrix may include one or more heme-containing enzymes, such as catalase and / or peroxidase, which can catalyze redox reactions with hydroperoxides, such as hydrogen peroxide (H₂O₂) generated during lactate oxidation. Heme-containing enzymes may be, for example, horseradish peroxidase, which catalyzes the redox reaction of hydrogen peroxide (H₂O₂) and 3,3′-diaminobenzidine (DAB) to produce a dark brown, insoluble product that can be detected and quantified colorimetrically.

[0078] Although the LFA 170A is described above as also including a capture element 174, a control element 175, and a suction core 176, in this embodiment, lactic acid detection can be performed, for example, on or at the coupling element 173. Therefore, the LFA does not need to include separate capture elements, control elements, and / or suction cores.

[0079] For example, in some embodiments, the LFA can be coupled to an optical device such as a CMOS or CCD camera configured to collect images of the dark brown precipitate of 3,3′-diaminobenzidine (DAB) produced by hydrogen peroxide oxidation to determine the initial concentration of lactic acid present in the sample. For example, in some embodiments, the conjugation element 173 of the LFA can be imaged by a camera such as a dedicated optical detector or a smartphone peripheral, and the image intensity can be analyzed by image software to estimate the concentration of the DAB precipitate, the concentration of hydrogen peroxide, and thus the initial concentration of lactic acid present in the sample. In some embodiments, the concentration of lactic acid present in the sample can be determined by: (1) recording an image of the DAB brown precipitate, (2) calculating a grayscale mode value using image processing software, and (3) correlating the grayscale mode value with the concentration of lactic acid present in a sample having a known lactic acid content. The grayscale mode values ​​that can be used for the image range from 0 to 255, with values ​​closer to 0 corresponding to a darker image and values ​​closer to 255 corresponding to a brighter image.

[0080] Lateral flow assays (LFAs) configured to detect lactate in blood and / or other biofluids overcome some of the drawbacks observed in lactate detection methods that rely on an electrochemical reaction to quantify the amount of hydrogen peroxide (H₂O₂) produced during lactate oxidation. As described above, the enzymatic reaction of hydrogen peroxide (H₂O₂) with 3,3′-diaminobenzidine (DAB) produces a brown precipitate that is insoluble in blood and / or biofluid samples and can be quantified by optical methods such as colorimetry. Furthermore, the reaction of hydrogen peroxide and DAB is carried out under pH and temperature conditions similar to those required for lactate oxidation. Therefore, the use of additives in the dry matrix of LFAs protects the detection and quantification enzymes from degradation, facilitating storage for up to 9 months, as further described herein. Conversely, electrochemical methods for detecting and quantifying lactate typically require high oxidation potentials to convert hydrogen peroxide into an electrical signal. These potentials can often trigger interfering reactions from other electrooxidizable substances present in blood and / or biofluid samples, leading to inaccurate results. In addition, immobilizing enzymes onto solid surfaces presents several challenges, including (1) the need for complex and / or time-consuming manufacturing and characterization methods, and the reduced stability of enzymes during storage.

[0081] In some embodiments, the detection and quantification enzymes may be contained in a dried matrix in the presence of one or more chemical reagents and / or stabilizing additives, said chemical reagents and / or stabilizing additives being configured to maintain the activity and stability of the enzymes during storage and during lactate oxidation in blood and / or other biofluid samples. For example, the dried matrix may comprise weak acids or bases (e.g., buffers) that are soluble in blood and / or other biofluid samples and can dissociate in the sample to establish an equilibrium between their acidic properties and their conjugates, maintaining the sample pH within a range where the enzyme exhibits high catalytic activity. In some embodiments, the dried matrix may include one or more buffers, such as phosphate-buffered saline (PBS), 2-ethanesulfonic acid (MES), tris(hydroxymethyl)aminomethane (TRIS), piperazine-N,N′-bis(PIPES), 3-morpholinopropane-1-sulfonic acid (MOPS), 2-[4-(2-hydroxyethyl)piperazine-1-yl]ethanesulfonic acid (HEPES), [tris(hydroxymethyl)methylamino]propanesulfonic acid (TAPS), N-cyclohexyl-2-aminoethanesulfonic acid (CHES), and / or N-cyclohexyl-3-aminopropanesulfonic acid (CAPS).

[0082] In some embodiments, the dried matrix may include polysaccharides, such as chitosan, a non-toxic, biocompatible biopolymer that can provide antimicrobial and antioxidant activity to maintain the chemical integrity of enzymes over extended periods. In some embodiments, the chitosan stabilizer may be accompanied by one or more reagents configured to increase the solubility of chitosan in blood and / or other biofluid samples. For example, in some embodiments, the dried matrix may include chitosan and weak organic acids such as formic acid, acetic acid, and / or propionic acid, suitable for increasing the solubility of chitosan in a volume of blood and / or biofluid. In some embodiments, the dried matrix may comprise a combination of additives including chitosan, acetic acid, and / or buffers, adsorbed on the surface of the conjugate 173 and configured to dissolve in a volume of blood and / or biofluid delivered from the sampling element 170.

[0083] Lateral flow assays (LFAs) configured to test for lactate in blood and / or other biological fluids, as described above, can detect lactate present in a variety of samples, including buffer solutions, serum, plasma, and / or whole blood. More specifically, in some embodiments, the LFA can exhibit a dynamic range of detectable lactate of 2-6 mM, and a sensitivity equal to or greater than 0.5 mM lactate in buffer and / or serum samples. In some embodiments, the LFA can exhibit cutoff lactate concentrations of 2 mM and 4 M in buffer / serum. The total time required to obtain lactate results using an LFA formulated for lactate detection is approximately 10 minutes. When accelerated degradation studies are conducted at 37°C, LFAs formulated for lactate detection remain relatively stable over time, with degradation primarily occurring in the first week of testing. More specifically, LFAs formulated for lactate detection remain stable at 37°C for up to 4 weeks, showing minimal changes in signal response, supporting the view that LFA detection will remain viable over a long period.

[0084] Procalcitonin

[0085] In some embodiments, the rapid testing device 170 may be an LFA (e.g., LFA 170A) configured to test for PCT biomarkers. For example, the effectiveness of using serum PCT biomarker concentrations in the blood for the diagnosis of sepsis is shown in Table 2 below, which presents the results of studies on the diagnosis of sepsis, severe sepsis, and septic shock based on serum PCT measurements.

[0086] Table 2:

[0087]

[0088] Procalcitonin (PCT) is a 116-amino acid peptide with a molecular weight (MW) of approximately 14.5 kDa and belongs to the calcitonin peptide family. The PCT molecule consists of three parts: an N-terminal region (57 amino acids), immature calcitonin (33 amino acids), and calcitonin C-terminal peptide 1 (CCP-1) (21 amino acids), also known as katacalcin. PCT is a precursor hormone of calcitonin, undetectable in healthy individuals because the peptide is not released into the bloodstream in the absence of systemic inflammation. However, in cases of sepsis caused by bacterial infection, PCT synthesis is induced in tissues and thus becomes detectable in the blood. Bacterial toxins such as endotoxins and cytokines (e.g., interleukin (IL)-1β, interleukin-6, and tumor necrosis factor (TNF)-α) can trigger PCT production. PCT levels can rise rapidly between 2 and 6 hours after bacterial infection, peaking between 6 and 24 hours. Besides bacterial infections, some fungal and parasitic infections are also associated with the release of PCT in the bloodstream. Other conditions that can lead to high levels of PCT in the body include recent major surgery, severe trauma, severe burns, prolonged cardiogenic shock, and chronic kidney disease.

[0089] Some extrathyroidal tissues lack the ability to cleave PCT into its mature form, calcitonin, leading to PCT accumulation in the blood. Therefore, PCT can serve as a relatively highly discriminative biomarker between bacterial and viral inflammation, making it useful in patients with sepsis. Furthermore, PCT levels can correlate with and / or indicate the severity of bacterial infections. In cases of sepsis, rapid diagnosis of bacterial infection reduces the risk of unnecessary or inappropriate antibiotic use, which can increase antibiotic resistance or toxic side effects in patients.

[0090] Routine methods for diagnosing sepsis caused by bloodstream infections include culturing blood, urine, cerebrospinal fluid, and bronchial fluid specimens. These tests typically require 24 to 48 hours to produce results, and this time usually helps identify the pathogen, providing information about the microbial type and its susceptibility to antibiotics. However, clinical symptoms can manifest in the absence of positive cultures, leading to medical treatment based on false-negative results. The half-life of PCT (25 to 30 hours), coupled with its specificity for bacterial infections and its near-absence in healthy individuals, makes PCT a suitable biomarker for bacterial infections.

[0091] PCT can be quantified using immunoassays based on the sandwich ELISA principle. In these immunoassays, an antibody-procalcitonin-antibody complex is formed and quantified using one or more instrumental techniques, including chemiluminescence, enzymatic, fluorescence, and turbidimetric immunoassays. For example, the chemiluminescence assay for PCT uses a two-step sandwich method. In this method, an anti-PCT monoclonal antibody conjugated to alkaline phosphatase is added to a patient sample in the presence of a reagent buffer. After incubation, paramagnetic particles coated with the monoclonal anti-PCT antibody are added to the test. PCT binds to the paramagnetic particles, while the anti-PCT antibody in solution reacts with different antigenic sites on the PCT molecule. The particles are separated from the unconjugated material by a magnet. A chemiluminescent substrate is added to the test, and the light produced by the reaction is measured using a photometer, where the generation of photons is proportional to the concentration of PCT in the sample.

[0092] Alternatively, PCT can be measured using a quantitative homogeneous assay based on Time Resolved Amplified Cryptate Emission technology (TRACE) (BRAHMS, Hennigsdorf, Germany). This assay involves directing a 337 nm nitrogen laser beam at a sample containing PCT and two fluorescently labeled antibodies that recognize different epitopes of the PCT peptide. Exposure to the laser excitation triggers a nonradiative energy transfer between the donor and acceptor molecules; the donor molecule emits a long-lived fluorescence signal at 620 nm, while the acceptor molecule emits a short-lived signal at 665 nm. As the donor and acceptor molecules approach each other by binding to PCT, the resulting signal is amplified at 665 nm and persists for several microseconds, long enough to be detected after the background fluorescence, which is common in biological samples, decays.

[0093] Lateral flow assays (LFAs), configured to test for PCT biomarkers (e.g., antigens) in blood (e.g., whole blood, serum, etc.), offer an alternative tool for the diagnosis of sepsis. (See above reference.) Figure 2 The LFA can be performed over a strip comprising one or more components mounted above a substrate 171. Components configured for the detection and quantification of PCT in blood and / or other biological fluids may include a sampling element 172, a conjugation element 173, a capture element 174, a control element 175, and a suction core 176.

[0094] As described above, substrate 171 can be a backing laminate or backing card configured to provide mechanical support to components of the LFA. As described above, substrate 171 can have any suitable shape, size, and / or configuration. For example, substrate 171 can be a rectangular backing card or strip of constant width and predetermined length, capable of providing sufficient surface area to accommodate various components of the LFA. Substrate 171 can be made of a semi-rigid polymer designed to provide uniformity and flatness. Substrate 171 may include one or more pressure-sensitive adhesives configured to facilitate the adhesion of various parts of the LFA, as further described herein.

[0095] Sampling element 172 may be a pad that provides a surface for receiving samples of blood and / or other biological fluids for analysis and facilitates the smooth, continuous, and uniform delivery of samples to other components of the lateral flow test strip. Sampling element 172 may have any suitable shape and / or size. In some embodiments, sampling element 172 may be a rectangular strip configured to adsorb and receive a volume of blood and / or other biological fluid samples. Sampling element 172 may be disposed on the surface of substrate 171 to provide mechanical support to the LFA. In some embodiments, sampling element 172 may include an adhesive coated on one surface of the sample pad to facilitate adhesion to the plastic backing stack. The shape and size of sampling element 172 may be predetermined such that the sampling element can be disposed on the plastic backing stack. The thickness of sampling element 172 may be selected to facilitate adhesion of sampling element 172 to the plastic backing stack while maintaining the mechanical structure of the pad. Furthermore, the thickness of the sampling element 172 can be selected to accommodate large amounts of blood and / or other biological fluids, prevent sample oversaturation on the pad, and guide the sample to the plastic backing stack. The sampling element 172 may be made of cellulose, nitrocellulose, glass fiber, and / or any other suitable material.

[0096] The conjugation element 173 for detecting and quantifying LFA of PCT from blood and / or other biological fluid samples can be a pad located downstream of sampling element 172, such as Figure 2As shown. The conjugation element 173 can have any suitable shape and / or size. In some embodiments, the sampling element 172 may be shaped as a rectangular strip with a width similar to that of the sampling member 171, which is disposed on the surface of the substrate 171 to provide mechanical support to the LFA. The conjugation element 173 may comprise a dried matrix (e.g., a salt-sugar matrix) including bioactive particles and additives. The bioactive particles contained in the matrix include specific antibodies and / or affinity reagents (e.g., DNA aptamers, protein binders, etc.) that have been immobilized on or within the conjugation element 173. For example, in some embodiments, the surface of the sampling element 172 may be impregnated with a buffered aqueous solution that provides an environment with a controlled pH. In some embodiments, the surface of the sampling element 172 may be impregnated with a buffer solution, including but not limited to borate buffer solution, phosphate buffered saline (PBS), 2-ethanesulfonic acid (MES), tris(hydroxymethyl)aminomethane (TRIS), piperazine-N,N′-bis(PIPES), 3-morpholinopropane-1-sulfonic acid (MOPS), 2-[4-(2-hydroxyethyl)piperazine-1-yl]ethanesulfonic acid (HEPES), [tris(hydroxymethyl)methylamino]propanesulfonic acid (TAPS), N-cyclohexyl-2-aminoethanesulfonic acid (CHES), and / or N-cyclohexyl-3-aminopropanesulfonic acid (CAPS).

[0097] The drying matrix of sampling element 172 may include one or more surfactants used as wetting agents to dissolve polar species present in the sample. For example, in some embodiments, the drying matrix of conjugation element 173 may include nonionic surfactants such as glycidol, tergitol, ethoxylated and alkoxylated fatty acids, ethoxylated amines, alkyl and nonylphenol ethoxylates, ethoxylated sorbitan esters, castor oil ethoxylates, etc. The drying matrix may contain one or more biocides formulated to promote extended shelf life of LFA by inhibiting a broad spectrum of microorganisms. The biocides may be formulated in low concentrations in the drying matrix of conjugation element 173 to minimize and / or avoid potential health hazards, toxicological problems, and disposal issues. For example, in some embodiments, the drying matrix may include 5-chloro-2-methyl-4-isothiazolin-3-one (CMIT), 2-methyl-4-isothiazolin-3-one (MIT), a proprietary glycol, a modified alkyl carboxylate, and / or other commercially available preservative formulations, such as proclin 300. TM In some embodiments, the drying matrix may include one or more detergents or any amphiphilic molecule that can be used for protein solubilization, such as Tween20, Triton X, octyl glucosinolate, etc.

[0098] The dried matrix of the conjugating element 173 may include one or more antibodies and / or affinity reagents conjugated to a molecule configured to allow detection. In some embodiments, the dried matrix may include one or more detection antibodies capable of binding PCT and exhibiting high stability. For example, in some embodiments, the detection antibody may include procalcitonin human antibodies, including monoclonal anti-PCT antibody 14A2cc, monoclonal anti-CT antibody 796, PP3, etc.

[0099] Detection antibodies can be immobilized onto one or more colored particles (e.g., blue latex, red colloidal gold, and / or any other suitable particles), fluorescent particles, magnetic particles, or any other suitable particles that can be used to capture and quantify PCT in blood and / or other biological fluid samples. In some embodiments, detection antibodies can be immobilized onto gold nanoparticles. The gold nanoparticles and / or gold nanoshells can be functionalized with antibodies that exhibit specific binding activity to certain regions of the PCT molecule (e.g., bioconjugation). During bioconjugation, the surface of the gold nanoparticles can be functionalized with the detection antibody using physical methods that rely on physical interactions between the detection antibody and the surface of the gold nanoparticles, such as ionic interactions, hydrophobic interactions, and / or dative binding. Physical interactions occur through the spontaneous adsorption of the antibody onto the surface of the gold nanoparticles. In the case of ionic interactions, positively charged groups in the detection antibody are attracted to the negatively charged surface of the gold nanoparticle. Hydrophobic interactions occur between the hydrophobic portion of the detection antibody and the metal surface.

[0100] The advantages of functionalizing gold nanoparticles with detection antibodies using physical methods include ease of manufacture, simplicity, low cost, rapid fabrication, and the use of minimal chemicals and / or additives that could cause harmful toxicological effects. However, some disadvantages of physical methods may include the use of large quantities of detection antibodies in the preparation of functionalized gold nanoparticles, the random orientation of detection antibodies, and the relatively easy substitution of detection antibodies by other molecules with similar characteristics. These disadvantages often lead to high assay variability and low PCT capture capacity due to the low specificity of the binding forms on gold nanoparticles. For example, antibody conjugation to the surface of gold nanoparticles can occur via nonspecific binding sites that can block regions of the antibody suitable for PCT capture. For example, in some cases, antibodies can be physically adsorbed onto the surface of gold nanoparticles through interactions between constant structural domains present in the heavy chain and the nanoparticle surface. In this configuration, the antigen-binding sites of the antibody can be partially used for PCT interaction. In other cases, antibodies can be physically adsorbed onto the surface of gold nanoparticles through interactions between PCT antigen-binding sites, which excludes the interaction between the antigen-binding sites and PCT.

[0101] Alternatively, in some embodiments, antibodies can be conjugated to gold nanoparticles via chemical methods involving covalent bonds, such as chemisorption of thiol derivatives, bifunctional linkers, and / or linker molecules. Direct functionalization of gold nanoparticles with thiol-derived groups can be achieved by generating strong bonds on the particle surface through chemical reactions between gold and sulfur atoms. For example, thiol-functionalized antibodies can be directly attached to gold nanoparticles. However, this approach presents challenges, such as the use of reaction conditions that may compromise the stability of the nanoparticles, and may require harsh conditions.

[0102] The embodiments, embodiments, and / or methods described herein can overcome these limitations, for example, by including the use of other groups that can be attached to the surface of gold nanoparticles using bifunctional connectors, which provide specific functionalization on the surface of the gold nanoparticles. For example, carboxylated polyethylene glycol (PEG) molecules functionalized with thiol groups (PEG-SH) can be used to functionalize the surface of gold nanoparticles. PEG molecules functionalized onto gold nanoparticles may also include carboxyl-terminated groups. These carboxyl-terminated groups can be modified with coupling chemistry, including water-soluble carbodiimide (EDC) and N-hydroxy-succinimide (NHS) compounds, to generate reactive functional groups that bind to primary amine groups in antibody molecules. The water-soluble carbodiimide reacts with the carboxyl moiety in the PEG-containing gold nanoparticles to generate an intermediate active group, which will react with the N-hydroxy-succinimide compound to form a reactive ester group. When in direct contact with the antibody, the primary amine group in the antibody reacts with the ester group formed on the surface of the gold nanoparticles. This reaction was designed to generate amide bonds to attach antibodies to gold nanoparticles without adding spacer molecules between them.

[0103] The capture element 174 for detecting and quantifying LFA of PCT from blood and / or other biological fluid samples may be a pad disposed near and / or downstream of the conjugation element 173, containing particles or molecules already immobilized in or on the capture element 174. (See above reference) Figure 2 As the sample flows downstream in a volume of blood and / or other biofluids, particles or molecules can be configured to bind to a detection antibody, which is conjugated to the colored particles described above with reference to conjugation element 173. In some embodiments, capture element 174 may comprise capture antibodies immobilized and / or chemically bound to the surface of capture element 174. The capture antibody may be configured to interact with the detection antibody to capture PCT bound to the detection antibody, resulting in a localized accumulation of the detection antibody and its conjugated colored particles. In some embodiments, the capture antibody may be adsorbed onto the surface of capture element 174.

[0104] As described above with reference to the detection antibody, the capture antibody may include procalcitonin antibodies such as monoclonal anti-PCT antibody 14A2cc, monoclonal anti-CT antibody 796, and PP3. The immobilized capture antibody may be configured to bind PCT molecules that have been pre-bound to the detection antibody (and its conjugated colored particles) in the conjugation element 173. Consequently, exposure of the capture element 174 to a sample of blood and / or other biological fluids containing PCT that has previously flowed through the conjugation element 173 can lead to the accumulation of colored particles associated with the capture antibody, which binds to PCT molecules present in the sample. This accumulation of colored particles on the capture element 174 can be recorded and quantified by one or more optical methods to determine the concentration of PCT in the sample. For example, in some embodiments, the colored particles accumulated on the capture element 174 can be determined by a standard lateral flow reader, such as the commercially available Leelu reader (LUMOS diagnostics), configured to detect colored particles, providing suitable optical sensitivity and a dynamic range sufficient to cover a wide concentration range.

[0105] The LFA may include a control element 175 to capture detection antibodies that would not otherwise be captured by the capture element 174. In other embodiments, the LFA does not need to include a control element. The aspirator 176 of the LFA configured for detecting and quantifying PCT from blood and / or other biological fluid samples may be a pad disposed near and / or downstream of the capture element 174 (or control element 175, if included). See reference Figure 2 The wick 176 may be configured to absorb or wick a portion of the sample that is not secured in or on the capture element 174 (and / or control element 175, if included).

[0106] The lateral flow assay (LFA) configured to test PCT in blood and / or other biological fluids described above can detect PCT present in a variety of samples, including buffer solutions, serum, plasma, and / or whole blood. More specifically, in some embodiments, the LFA can exhibit a detectable PCT dynamic range of 0.2 ng / mL to 2 ng / mL in buffer and serum, and a sensitivity equal to or greater than 0.1 ng / mL. In some embodiments, the LFA can exhibit PCT cutoff concentrations of 0.2 ng / mL and 0.5 ng / mL in buffer / serum. The total time required to obtain results using the LFA configured for PCT detection is approximately 10 minutes. The LFA configured for PCT detection remains relatively stable during accelerated stability testing at 37°C, without significant conjugate release or flow through the lateral flow strip.

[0107] While tests for serum lactate and / or serum PCT concentrations have been described above, it should be understood that testing blood (e.g., whole blood or other suitable portions of blood) will produce similar or substantially the same results. Although lactate and PCT biomarkers have been described above, it should be understood that they are presented merely by way of example and not limitation. In some embodiments, a rapid testing device (e.g., LFA 170A) may be configured to test any suitable biomarker associated with and / or indicating said disease or condition, sepsis and / or any other infectious or disease condition. Furthermore, it should be understood that the rapid testing device 170 and / or LFA 170A (and / or any other suitable flow-based assay) may be used in conjunction with any fluid delivery device described herein with reference to specific embodiments.

[0108] fit

[0109] In some embodiments, the rapid testing device 170 may be an LFA (e.g., LFA170A), configured to use aptamers to test for any suitable biomarkers associated with sepsis and / or any other infectious condition. Aptamers are single-stranded DNA or RNA molecules that can selectively bind to a corresponding target with high affinity and specificity. These single-stranded molecules consist of a variable region containing 20-40 bases at the midpoint and two constant regions on either side containing binding sites. Aptamers can fold into secondary structures and three-dimensional shapes due to intermolecular hybridization. The equilibrium dissociation constant for aptamer-target binding is in the range of 1 picomolar (pM) to 1 nanomolar (nM). Aptamers have similar affinities to target molecules as antibodies and can be generated for desired targets, such as small toxic molecules, non-immunogenic targets, or single molecules that do not bind to antibodies. Furthermore, aptamers can be reversibly denatured by heat or chemicals, which is not possible with antibodies.

[0110] Aptamers are similar to antibodies in target recognition and various applications. However, the use of aptamers can present advantages over the use of antibodies, including, for example, manufacturing via in vitro methods (which, in contrast to the complex experiments required to obtain antibodies from bacteria, cell cultures, and / or animal cells (including human cells), rely on easily controlled and highly reproducible chemical reactions), the ability to bind to targets that antibodies do not recognize (such as ions, small molecules, complex multi-site molecules, proteins, bacterial cells, viruses, and / or cancer cells), the ability to amplify in large quantities in a short time via polymerase chain reaction (PCR), the ease of modification to introduce functional motifs (e.g., fluorophores, quenchers, and nanomaterials), stability under harsh conditions, and safety of use in in vivo due to their non-immunogenic characteristics. In some cases, aptamers can improve transport properties, allowing for cell-specific targeting and improved tissue penetration.

[0111] Aptamers can be customized for specific targets obtained through systematic evolution of ligands using the SELEX (Sequential Elasticity Array) method. This method comprises three main steps: library generation, selection, and amplification. In the first step, a random library is designed and synthesized using combinatorial chemistry to generate oligonucleotides containing variable regions of 20-40 bases each, with upstream and downstream primer binding sites flanking each end. The resulting library may contain 10¹²-10¹⁵ ssDNA or RNA sequences. In the second step, the target molecule is incubated with the library for several minutes in the presence of a binding buffer. The aptamer binds to the target, forming an aptamer-target complex, while non-specific sequences are retained in the binding buffer. The aptamer-target complex can be collected and washed several times with a washing buffer. The aptamer can then be separated from the aptamer-target complex by treatment with an elution buffer. The selection step may include an anti-selection procedure where the target is replaced with an analogue, excluding nucleic acid sequences that bind to the analogue. In the third step, for DNA, the sequences eluted in the second step are amplified by PCR; for RNA, amplification is performed by reverse transcriptase (RT)-PCR to generate a sublime library for the second round of the SELEX method. This method can be repeated several times until aptamers with high target specificity are produced.

[0112] When the affinity of the target-bound sequences is saturated, they are sent for cloning and sequencing, followed by identification of the target-bound aptamer sequences with high sensitivity and specificity. Several techniques can be used to improve the separation of unbound sequences from the aptamer-target complex. For example, in some cases, the selection of aptamers can include SELEX based on nitrocellulose membrane filtration, affinity chromatography and magnetic bead-based SELEX, capillary electrophoresis and / or microfluidic-based SELEX. Nitrocellulose membrane filtration-based SELEX uses a nitrocellulose membrane to retain the aptamer-target complex and removes unbound oligonucleotide sequences based on size. Multiple micron-sized pores on the membrane surface allow DNA or RNA oligonucleotides to pass through and trap proteins on the membrane. The material is then amplified by PCR or RT-PCR for the next round of manufacturing. Affinity chromatography and magnetic bead-based SELEX use agarose beads packed on a column as a stationary phase. Magnetic beads are also used to immobilize targets through physical interactions or chemical reactions between a specific tag and its ligand (on the bead). Capillary electrophoresis and microfluidic-based SELEX are used to improve separation speed, resolution, and capacity while minimizing sample dilution. In this method, unbound nucleotides are separated from aptamer-target complexes due to differences in electrophoretic mobility in an electric field. Aptamers can be obtained by the migration rates of the target, ligand, or a mixture of target-ligand complexes. Compared to other methods, capillary electrophoresis-based SELEX can be used to select aptamers in multiple rounds. Microfluidic-based SELEX technology is an automated and miniaturized platform that enables aptamer selection on a chip. To automate the selection process, the system includes several modules with micropumps, microvalves, reservoir manifolds, waste chambers, and PCR chambers. Other methods, including atomic force microscopy, high-throughput sequencing, graphene oxide, UV crosslinking, flow cytometry, and surface plasmon resonance (SPR), can be combined with the SELEX method. These methods enrich the selection means and improve the efficiency of aptamer selection.

[0113] Applications of aptamers include in vivo therapeutics, molecular biosensors, target capture, drug delivery, new drug development, hazard detection, environmental monitoring, clinical diagnostics, biomarker discovery, and food inspection. Aptamers are also used as recognition elements in analytical tools, including electrochemical and fluorescent biosensors, colorimetric assays, surface plasmon resonance assays, and amplification techniques.

[0114] Detection

[0115] In some cases, the rapid testing device 170 (e.g., LFA 170A and / or any other suitable rapid testing device) may be configured to present test results that can be visually inspected and / or evaluated by a person (e.g., a doctor, nurse, technician, etc.). For example, a doctor, nurse, technician, etc., may visually inspect the capture element 174 of the LFA 170A to determine the presence of a band along the capture element 174. Additionally, the control element 175 of the LFA 170A may be visually inspected to verify the performance of the test. In some such cases, visual inspection by a person can be performed relatively simply and may not require additional equipment to provide qualitative results (e.g., positive or negative test results).

[0116] In other cases, the LFA 170A can be configured to output test results, which can then be used by one or more electronic devices (e.g., Figure 1 The illustrated electronic device 190 receives, inspects, analyzes, interprets, etc. For example, in some cases, a portable strip reader can be used to read, scan, and / or evaluate one or more stripes along the capture element 174 and / or control element 175. The strip reader may include a camera, scanner, reader, etc., which may use a complementary metal-oxide-semiconductor (CMOS) device, charge-coupled device (CCD), and / or any other suitable detection device or camera to detect one or more stripes. In some embodiments, the strip reader may be configured to define a data or digital representation of a test result (strip), which may be qualitative, semi-quantitative, and / or quantitative. For example, the intensity of the capture element may be proportional to the concentration of the analyte, thereby allowing for the quantification of the analyte. In some cases, the strip reader may be configured to read, scan, and / or identify the presence and intensity of one or more stripes, thereby providing qualitative and quantitative data. In some implementations, the electronic device 190 may be integrated into / on the rapid test apparatus 170, or it may be a standalone device in which the rapid test apparatus 170 and / or one or more boxes (e.g., one or more portions of the rapid test apparatus 170) can be inserted for reading and analysis.

[0117] In some implementations, the strip reader may be configured to provide qualitative and / or quantitative data as input to the electronic device 190, which may analyze, process, and / or otherwise use the data to generate one or more qualitative and / or quantitative test results. The electronic device 190 may be any suitable hardware-based computing device configured to receive, process, define, and / or store data, such as one or more diagnostic test results, test criteria on which measurement results are based, predetermined and / or predefined treatment plans, patient profiles, disease profiles, etc. Additionally, the electronic device 190 may be configured to transmit and / or receive data via wired or wireless connections or networks. In some implementations, the electronic device 190 may be, for example, a mobile electronic device (e.g., a smartphone, tablet, laptop, and / or any other mobile or wearable device), a personal computer (PC), a workstation, server equipment or a distributed network of server equipment, a virtual server or machine, a virtual private server (which executes and / or runs as an instance or client on a physical server or group of servers), and / or any other suitable device. In some embodiments, electronic device 190 may be configured to provide a graphical and / or digital representation of the test results generated by rapid testing device 170. Additionally, in some embodiments, based on data associated with and / or representing the test results, electronic device 190 may be configured to determine and graphically or digitally present one or more diagnoses, one or more treatment plans, one or more simulations, and / or any other suitable data associated with bodily fluid samples, patients, and / or the medical treatment of patients.

[0118] As described above, in some embodiments, the transfer device 105 may be configured to transfer a first amount of bodily fluid to the rapid testing device 170 and transfer at least some of a second amount of bodily fluid to one or more optional fluid collection devices 195. For example, a second portion or sampling portion of the transfer device 105 may include an outlet or port and / or be in fluid communication with an outlet or port, which may allow the second amount of bodily fluid to be transferred out of the second portion or sampling portion of the transfer device 105. In some cases, one or more optional fluid collection devices 195 may be physically and / or fluidly coupled to the transfer device 105 (e.g., via an outlet or port) to receive at least some of the second amount of bodily fluid.

[0119] In some embodiments, one or more optional fluid collection devices 195 may be any one or more suitable devices for at least temporary containment of bodily fluids. For example, fluid collection device 195 may include, but is not limited to, any suitable vessel, container, reservoir, bottle, adapter, dish, vial, syringe, device, diagnostic and / or testing machine, etc. In some embodiments, the fluid collection device may be substantially similar to or identical to a known sample container, such as... (Manufactured by Becton Dickinson and Company (BD), BacT / SN or BacT / FA (manufactured by Biomerieux, Inc.) and / or any suitable reservoir, vial, microtube, microliter vial, nanoliter vial, container, microcontainer, nanocontainer, etc. In some embodiments, the fluid collection device may be substantially similar to or identical to any sample reservoir described in U.S. Patent No. 8,197,420 (“'420 Patent”), filed December 13, 2007, entitled “Systems and Methods for Parenterally Procuring Bodily-Fluid Samples with Reduced Contamination”, the disclosure of which is incorporated herein by reference in its entirety.

[0120] In some embodiments, the fluid collection device 195 may be empty of contents before receiving a sample volume of body fluid. For example, in some embodiments, the fluid collection device 195 or reservoir may be defined and / or configured to define or generate vacuum, suction, and / or negative pressure conditions, such as a vacuum-based collection tube (e.g., (e.g., syringes, etc.) In some embodiments, the fluid collection device 195 may be physically and / or fluidly coupled to the delivery device 105 (e.g., outlet or port) such that negative pressure conditions within the fluid collection device 195 facilitate the aspiration of bodily fluids from the patient and their entry into or through one or more portions of the delivery device 105, as further described herein with reference to specific embodiments.

[0121] In some embodiments, the fluid collection device 195 may include any suitable additives, culture media, substances, enzymes, oils, fluids, etc. For example, the fluid collection device 195 may be a sample or culture flask, including, for example, aerobic or anaerobic culture media. The sample or culture flask may be configured to receive a body fluid sample, which may then be tested (e.g., after incubation by in vitro diagnostic (IVD) testing and / or any other suitable test) for the presence of Gram-positive bacteria, Gram-negative bacteria, yeast, fungi, and / or any other organisms in the body fluid sample. In some cases, if such a test of the culture medium yields a positive result, the culture medium may subsequently be tested using a nucleic acid-based system (e.g., one or more PCR-based systems, one or more hybridization probes, one or more nucleic acid amplification assays (NAAT), etc.) to identify a specific organism. In some embodiments, in addition to or in place of the culture medium, the sample reservoir may include, for example, any suitable additives. Such additives may include, for example, heparin, citrate, ethylenediaminetetraacetic acid (EDTA), oxalate, sodium polyethanolsulfonate (SPS), etc. In some embodiments, the fluid collection device 195 may include any suitable additives or culture media, and may be evacuated and / or otherwise de-aired.

[0122] While “culture medium” is described above as a substance configured to react with organisms (e.g., microorganisms, such as bacteria) in body fluids, and “additive” is described above as a substance configured to react with portions of body fluids (e.g., constituent cells of blood, synovial fluid, etc.), it should be understood that the sample reservoir can contain any suitable substance, liquid, solid, powder, lyophilized compound, gas, etc. Furthermore, when referring to “additive” within the sample reservoir, it should be understood that the additive can be a culture medium, such as aerobic and / or anaerobic culture media contained in culture flasks, additives and / or any other suitable substance or combination of substances contained in culture flasks and / or any other suitable reservoir (e.g., those described above). That is, the embodiments described herein can be used with any suitable fluid reservoir, etc., containing any suitable substance or combination of substances.

[0123] In some embodiments, a second volume of body fluid contained in a second portion or sampling portion of the transport device 105 and / or in optional one or more fluid collection devices 195 can be used as a biological sample for one or more tests, assays, and / or diagnostic procedures. In some cases, isolating the first volume of body fluid from the second volume of body fluid can isolate contaminants, etc., from the first volume of body fluid and / or from the isolation portion of the transport device 105. Isolation can also make the second volume of body fluid substantially free of contaminants. Thus, the second portion or the second volume of body fluid can be used for one or more tests, such as blood culture tests, which may be relatively sensitive to contaminants (e.g., the presence of contaminants can produce results of contamination). In this way, the system 100 can be configured to acquire a first volume of body fluid and a second volume of body fluid, the first volume of body fluid being used for tests with relatively low sensitivity to contamination, and the second volume of body fluid being used for tests with relatively high sensitivity to contamination. In some cases, testing the first volume of body fluid can provide relatively rapid initial results that can inform one or more treatment options, while testing the second volume of body fluid can provide more detailed test results that typically require a longer time to form. Therefore, for time-sensitive medical conditions (e.g., sepsis), the initial results of testing the first volume of fluid can allow doctors or physicians to provide rapid initial treatment while a second volume of fluid is tested in more detail.

[0124] Figure 3 This is a schematic diagram of a fluid transfer and measurement system 200 according to an embodiment. The fluid transfer and measurement system 200 (also referred to herein as the "system") may include at least a fluid transfer device 205 and a rapid diagnostic test device 270. Additionally, the system 200 may include at least one fluid collection device 295, which may be physically and / or fluidly coupled to the fluid transfer device 205.

[0125] The fluid transfer device 205 (also referred to herein as the “transfer device”) may have any suitable shape, size, and / or configuration. In some embodiments, the transfer device 205 may be configured to draw bodily fluids (e.g., blood) from a patient and allow them to enter and / or pass through the transfer device 205. Furthermore, the transfer device 205 may be configured to transfer at least some of the drawn bodily fluids to one or more other devices, reservoirs, containers, vials, machines, tests, assays, etc., such as the rapid diagnostic testing device 270 and / or one or more fluid collection devices 295.

[0126] The transfer device 205 includes a housing 210 and an actuator 250. The housing 210 of the device 205 may have any suitable shape, size, and / or configuration. For example, in some embodiments, the housing 210 may have dimensions at least in part based on the initial amount or volume of bodily fluid configured to be transferred into and / or isolated within a portion of the housing 210. In some embodiments, the housing 210 may have dimensions and / or shape configured to increase the ergonomics and / or usability associated with the device 205. Furthermore, in some embodiments, one or more portions of the housing 210 may be formed of a relatively transparent material configured to allow a user to visually inspect and / or verify the flow of bodily fluid through at least a portion of the housing 210.

[0127] The housing 210 has and / or forms an inlet 212 and an outlet 213, defining at least one fluid flow path 215 therebetween. The inlet 212 can be any suitable inlet, opening, port, stopcock, lock (e.g., Luer lock), seal, coupler, valve (e.g., one-way, check valve, duckbill valve, umbrella valve, etc.), conduit, tubing, etc. The inlet 212 is configured to fluidly couple the housing 210 to a source of bodily fluids (e.g., a patient). For example, inlet 212 may be coupled to a lumen-containing device configured for percutaneous placement within a patient (e.g., a butterfly needle, intravenous (IV) catheter, peripherally inserted central catheter (PICC), midline, intermediate lumen-containing device, etc.). Thus, fluid can be transferred between housing 210 and the patient via inlet 212 and any one or more lumen-containing devices coupled between housing 210 and the patient. More specifically, transfer device 205 may be configured to transfer bodily fluids from the patient and / or any other source of bodily fluids through inlet 212 (and / or any lumen-containing device coupled thereto) and into housing 210 via inlet 212, as described further in detail herein.

[0128] like Figure 3 As shown, housing 210 defines one or more fluid flow paths 215 between inlet 212 and outlet 213. As described in further detail herein, transfer device 205 and / or housing 210 can be configured to switch between any number of states, operating modes, and / or configurations to selectively control the flow of bodily fluids through one or more fluid flow paths 215. Furthermore, transfer device 205 and / or housing 210 can be configured to switch automatically (e.g., based on pressure differential, time, electronically, membrane saturation, absorbent, and / or barrier material, etc.) or by intervention (e.g., user intervention, mechanical intervention, etc.).

[0129] Outlet 213 is in fluid communication with one or more fluid flow paths 215 and is configured to selectively receive bodily fluid flow from inlet 212 (via fluid flow path 215). Outlet 213 can be any suitable outlet, opening, port, stopcock, lock, seal, coupler, valve, pipe, conduit, etc., configured to be physically and / or fluidly coupled to any suitable device coupled to outlet 213, such as fluid collection device 295 (e.g., fluid or sample reservoir, syringe, vacuum-sealed container, culture flask, etc.). In some embodiments, outlet 213 and fluid collection device 295 may be integrally formed. In other embodiments, outlet 213 may be at least temporarily coupled to fluid collection device 295 by adhesives, resistance fits, mechanical fasteners, threaded couplings, puncture or perforation arrangements, any number of mating grooves and / or any other suitable coupling or combination thereof. For example, in some embodiments, outlet 213 may include and / or may be coupled to fluid transfer adapters, such as those described in U.S. Patent No. 10,123,783 (“'783 Patent”), filed March 2, 2015, entitled “Apparatus and Methods for Disinfection of a Specimen Container”, and / or in U.S. Provisional Patent Application No. 62 / 986,244 (“'244 Application”), filed March 6, 2020, entitled “Universal Transfer Adapters and Methods of Using the Same”, and / or may be coupled to fluid transfer devices, such as those described in U.S. Patent No. 10,772,548 (“'548 Patent”), filed June 2, 2015, entitled “Sterile Bodily-Fluid Collection Device and Methods”, the disclosure of each of which is incorporated herein by reference in its entirety. In such embodiments, the fluid transfer adapter may be coupled to a portion of the fluid collection device 295 and / or may receive a portion of the fluid collection device 295, and may establish fluid communication between the outlet 213 and the fluid collection device 295. In other embodiments, the outlet 213 may be connected via an intermediary structure ( Figure 3 (Not shown in the image) Such as sterile tubing, operatively coupled to the fluid collection device 295.

[0130] In some embodiments, the outlet 213 is arranged such that it can be physically and / or fluidly sealed before being coupled to the fluid collection device 295. In some embodiments, the outlet 213 can be switched from a sealed configuration to an unsealed configuration in response to being coupled to the fluid collection device 295 and / or in response to a negative pressure difference between the environment within the outlet 213 and / or the housing 210 and the environment within the fluid collection device 295.

[0131] The fluid collection device 295 can be any suitable device for at least temporarily containing bodily fluids, such as any device described in detail above with reference to the fluid collection device 195 (e.g., a vacuum-sealed container, sample reservoir, syringe, culture flask, etc.). In some embodiments, the fluid collection device 295 can be a sample reservoir including a vacuum seal that maintains negative pressure conditions (vacuum conditions) within the sample reservoir, which in turn can facilitate the extraction of bodily fluids from the patient via vacuum or suction, through the transfer device 205, and into the sample reservoir. As further described in detail herein, in embodiments where the fluid collection device 295 is a vacuum-sealed container, the user can couple the fluid collection device 295 to the outlet 213 to initiate a flow of bodily fluid from the patient and allow it to enter the device 205, such that a first portion or initial portion of the bodily fluid flow is transferred to and / or isolated by, for example, the rapid diagnostic test device 270, and that a second portion or subsequent portion of the bodily fluid flow bypasses and / or otherwise departs from the rapid diagnostic test device 270 and enters the fluid collection device 295 (e.g., via the outlet 213).

[0132] The actuator 250 of device 205 is at least partially disposed within housing 210 and configured to control, guide, and / or otherwise facilitate selective flow of fluid through at least a portion of housing 210 and / or at least a portion of one or more fluid flow paths 215. The actuator 250 may have any suitable shape, size, and / or configuration. In some embodiments, the actuator 250 may be a component or device configured to switch between two or more states (e.g., at least a first state and a second state). For example, the actuator 250 may be a valve, plunger, seal, diaphragm, bladder, baffle, plate, rod, switch, and / or the like. The actuator 250 may be actuated in any suitable manner and / or switched between any number of states (e.g., at least a first state and a second state). For example, switching the actuator 250 may include activating, pressing, moving, translating, rotating, switching, sliding, opening, closing, and / or otherwise reconfiguring the actuator 250.

[0133] In some embodiments, actuator 250 may be configured to switch between at least a first and a second state in response to manual actuation by a user (e.g., manual application of force to a button, slider, plunger, switch, valve, rotating member, conduit, etc.). In other embodiments, actuator 250 may be configured to automatically switch between at least a first and a second state in response to a pressure difference (or no pressure difference), a change in potential or kinetic energy, a change in composition or configuration (e.g., a portion of the actuator may at least partially dissolve or change), and / or so on. In other embodiments, actuator 250 may be mechanically actuated or switched and / or electrically actuated or switched (e.g., by a motor, spring release mechanism, and / or so on) based on a predetermined time, the volume of bodily fluid received, the volumetric flow rate of the bodily fluid, the flow rate of the bodily fluid, etc. While examples of actuators and / or ways in which actuators can switch are provided, it should be understood that they are given merely as examples and not as limitations.

[0134] exist Figure 3 In the illustrated embodiment, actuator 250 may be configured to selectively establish fluid communication between inlet 212 and rapid diagnostic testing device 270 when in a first state, and selectively establish fluid communication between inlet 212 and outlet 213 when in a second state. When in the first state, actuator 250 may be configured to allow bodily fluids to reach or enter rapid diagnostic testing device 270 from inlet 212, through at least a portion of fluid flow path 215. In some embodiments, actuator 250 may be configured to isolate, separate, disconnect, and / or otherwise prevent fluid communication between outlet 213 and inlet 212, at least a portion of fluid flow path 215, and / or rapid diagnostic testing device 270. When in the second state, as further described herein, actuator 250 may be configured to allow a subsequent volume of bodily fluid (e.g., a volume of bodily fluid following the initial volume) to be transferred from inlet 212 through at least a portion of fluid flow path 215 to outlet 213 (and / or fluid collection device 295 fluidly coupled to outlet 213). Furthermore, when in the second state, as further described herein, actuator 250 may be configured to isolate, separate, disconnect, and / or otherwise prevent fluid communication between rapid diagnostic test device 270 and at least a portion of inlet 212, outlet 213, and / or fluid flow path 215.

[0135] The rapid diagnostic test device 270 (also referred to herein as the “rapid test device” or simply the “test device”) may have any suitable shape, size, and / or configuration. In some embodiments, the rapid test device 270 may be removably coupled to the transmission device 205 or any suitable portion thereof (e.g., an inlet portion, an outlet portion, an isolation portion, a sampling portion, and / or any other suitable portion). In other embodiments, the rapid test device 270 may be integrated into the transmission device 205. For example, the transmission device 205 and the rapid test device 270 may be formed integrally or singly and / or the transmission device 105 and the rapid test device 170 may be integrated in other ways. In other embodiments, the transmission device 205 may include and / or may form ports, adapters, and / or receiving portions to which the rapid test device 270 may be coupled, or the rapid test device 270 may be inserted into the ports, adapters, and / or receiving portions to establish fluid communication between them. In some such implementations, coupling the rapid test device 270 to the transmission device 205 can be used to switch one or more flow controllers, valves, diaphragms, ports, seals, etc., from a closed or sealed state to an open state, allowing fluid communication between the transmission device 205 and the test device 270.

[0136] In some embodiments, the rapid testing device 270 may be configured to receive a first volume of bodily fluid from the transmission device 205 and use the first volume of bodily fluid to perform one or more tests, assays, and / or diagnostic procedures. The rapid testing device 270 may be any suitable testing device. For example, as referenced above... Figure 2 As detailed in the LFA 170A shown, the rapid testing device 270 can be an LFA, etc. In some embodiments, the testing device 270 can be an LFA configured to test for the presence of a specific analyte or biomarker that can provide information for diagnosing a patient's condition such as sepsis and / or any other disease state. For example, an LFA can be configured to test for lactate and / or PCT biomarkers, which can be indicators of sepsis. In other embodiments, the testing device can be an LFA configured to test for the conditions described above. Figure 2 Any target analytes and / or biomarkers described in the LFA 170A shown.

[0137] In some cases, the rapid testing device 270 can be configured to output a test result associated with the volume of bodily fluid transferred from the transmission device 205 when the transmission device 205 and / or the actuator 250 are in a first state. The test result (e.g.) Figure 3(As indicated by the arrow marked "Output") The output can be detected and / or evaluated by a human visual inspection, and / or by one or more electronic devices (e.g., electronic device 290). In some cases, the test results output by the rapid testing device 270 can be qualitative, semi-quantitative, and / or quantitative. Therefore, the rapid testing device 270 may be similar to or identical in structure and / or function to the rapid testing device 170 described in detail above, and thus will not be described in detail herein.

[0138] As described above, system 200 can be used to obtain one or more volumes of bodily fluid from a patient, which can be used for one or more testing, assay, and / or diagnostic procedures. For example, in some cases, users such as doctors, physicians, nurses, phlebotomists, technicians, etc., can manipulate device 205 to establish fluid communication between inlet 212 and a source of bodily fluid (e.g., a patient's vein, cerebrospinal fluid (CSF) from the spinal canal, urine collection, and / or the like). As a specific example, in some cases, inlet 212 may be coupled to a needle or the like and / or may include a needle or the like, which can be operated to pierce the patient's skin and insert at least a portion of the needle into the patient's vein, thereby placing inlet 212 in fluid communication with a source of bodily fluid (e.g., a vein, IV catheter, PICC, etc.).

[0139] In some cases, when inlet 212 is positioned in fluid communication with a source of bodily fluid (e.g., a portion of a patient), actuator 250 may be in a first state such that at least a portion of fluid flow path 215 establishes fluid communication between inlet 212 and rapid testing device 270 (and / or a portion of device 205 to which rapid testing device 270 is coupled). Thus, transfer device 205 may be configured to transfer an initial volume of bodily fluid from a source of bodily fluid (e.g., a patient) to rapid testing device 270. In some embodiments, the initial volume of bodily fluid may flow passively (e.g., without user intervention and / or switching of one or more components) to the rapid testing device 270 in response to positive pressure associated with the patient’s vascular system and / or in response to any fluid transfer method described in U.S. Patent Publication No. 2018 / 0353117 (“'117 Publication”), filed June 11, 2018, entitled “Fluid Control Devices and Methods of Using the Same”, the disclosure of which is incorporated herein by reference in its entirety.

[0140] In other embodiments, the transfer device 205 and / or a portion thereof may be configured to generate a negative pressure differential (e.g., partial vacuum, suction, and / or etc.) within at least a portion of the fluid flow path 215, which can initiate and / or sustain the flow of an initial volume of bodily fluid from a bodily fluid source to the rapid testing device 270. For example, in some cases, the actuator 250 may be stored in a third state (e.g., a storage state) before use and may be transitioned from the storage state to a first state to initiate the flow of an initial volume of bodily fluid. In such cases, the transition of the actuator 250 can generate a negative pressure that can draw bodily fluid from the inlet 212 to the rapid testing device 270. In some such embodiments, the actuator 250 can be switched to generate a negative pressure differential in a manner similar to and / or substantially the same as that described in any of the following U.S. patents or U.S. patent publications: U.S. Patent No. 8,535,241 (“'241 Patent”), filed October 22, 2012, entitled “Fluid Diversion Mechanism for Bodily-Fluid Sampling”; U.S. Patent No. 9,060,724 (“'724 Patent”), filed May 29, 2013, entitled “Fluid Diversion Mechanism for Bodily-Fluid Sampling”; U.S. Patent No. 9,155,495 (“'495 Patent”), filed December 2, 2013, entitled “Syringe-Based Fluid Diversion Mechanism for Bodily-Fluid Sampling”; and U.S. Patent No. 9,155,495 (“'495 Patent”), filed June 23, 2016, entitled “Devices and Methods for Syringe Based Fluid”. U.S. Patent Publication No. 2016 / 0361006 (“'006 Publication”) entitled “Transfer for Bodily-FluidSampling”; and / or U.S. Patent Publication No. 2020 / 0253524 (“'524 Publication”) filed February 8, 2019, entitled “Devices and Methods for Bodily Fluid Collection and Distribution”, the disclosure of each of these patents or patent publications is incorporated herein by reference in its entirety. In other embodiments, as described in further detail herein with reference to other embodiments, an initial volume of bodily fluid may flow to rapid testing device 270 in response to a negative pressure differential generated by fluid collection device 295.

[0141] The initial volume of the body fluid can be any suitable volume of body fluid, such as any of the volumes or amounts described above. For example, in some cases, the transfer device 205 may remain in a first state or configuration until a predetermined and / or desired volume (e.g., the initial volume) of body fluid is transferred to the rapid testing device 270. In some embodiments, the initial volume may be associated with and / or at least partially based on a desired volume sufficient to enable the rapid testing device 270 to perform one or more tests or determinations. In other embodiments, the initial volume of the body fluid may be associated with an amount or volume of body fluid equal to or greater than the volume associated with the fluid flow path defined between the body fluid source and the rapid testing device 270, and / or at least partially based on said amount or volume. In other embodiments, the transfer device 205 may be configured to transfer a flow of body fluid (e.g., the initial volume) to the rapid testing device 270 until the pressure differential between the rapid testing device 270 and the inlet 212 or the body fluid source becomes substantially equal and / or otherwise decreases below a desired threshold.

[0142] In some embodiments, when the initial volume is transferred to, for example, a sampling element (e.g., sampling element 171), the rapid testing device 270 can initiate the testing and / or determination of the initial volume of body fluid. In some cases, the rapid testing device 270 may be configured to provide one or more solutions, buffers, mixtures, additives, and / or the like that can be mixed or combined with the initial volume. In this way, the initial volume of body fluid (whether alone or mixed with other components) can flow through the rapid testing device 270 (e.g., as referenced above). Figure 2 The aforementioned LFA (Lactic Acid Analyzer) can then perform one or more tests or determinations on the initial volume. For example, in some cases, as described in detail above, the rapid testing device 270 can be an LFA configured to test for the presence of lactic acid and / or PCT. Furthermore, as described in detail above, once the test or determination is completed, the rapid testing device 270 can be configured to output test results that can be detected and / or evaluated by a person and / or one or more electronic devices.

[0143] After the initial volume of bodily fluid has been transferred and / or converted into the rapid testing device 270, the transfer device 205 can transition from a first state or configuration to a second state or configuration. For example, in some embodiments, when the initial volume of bodily fluid is transferred into the rapid testing device 270, the actuator 250 can transition from its first state to its first state, which in turn places the transfer device 205 in its second state. In some embodiments, the arrangement of the transfer device 205 may prevent it from transitioning to the second state before the initial volume is collected in the rapid testing device 270.

[0144] In some embodiments, the arrangement of the delivery device 205, actuator 250, and / or rapid testing device 270 allows the flow of bodily fluid entering the rapid testing device 270 to substantially stop or slow down in response to receiving an initial volume. In some cases, a user can visually inspect a portion of the device 205 and / or housing 210 to determine that the initial volume of bodily fluid is contained in the rapid testing device 270 and / or that the flow of bodily fluid entering the rapid testing device 270 has slowed down or substantially stopped. In some embodiments, a user can apply force to the actuator 250 and / or otherwise actuate the actuator 250 to switch the actuator 250 from its first state to its first state. In other embodiments, the actuator 250 can switch automatically (e.g., without user intervention). Furthermore, in some embodiments, the device 205 and / or actuator 250 can switch from the first state to a second state when the rapid testing device 270 performs one or more tests or measurements on the initial volume of bodily fluid. In other words, the rapid testing device 270 can measure an initial volume of body fluid, while the device 205 is used to transfer one or more subsequent volumes of body fluid (e.g., in one or more parallel processes).

[0145] In some embodiments, the transition of actuator 250 from its first state to its second state (e.g., placing the transfer device 205 in its second state or configuration) can isolate, separate, separate, and / or retain the initial volume of bodily fluid within the rapid testing device 270. In other words, actuator 250 can isolate and / or separate the rapid testing device 270 from one or more portions of the inlet 212, outlet 213, and fluid flow path 215. As further described in detail herein, in some cases, contaminants, such as microorganisms remaining on skin detached during a venipuncture event, other external sources of contamination, colonization of catheters and PICC lines used for sample collection, and / or so on, may be entrained and / or contained in the initial volume of bodily fluid. Therefore, these contaminants are isolated within the initial volume. Furthermore, as described in detail above, the arrangement of the rapid testing device 270 can make the tests and / or measurements performed by the rapid testing device 270 less susceptible to such contamination, meaning that the accuracy of the test results output by the rapid testing device 270 is unaffected by such contamination.

[0146] In addition to isolating the rapid testing device 270 from at least a portion of the inlet 212, outlet 213, and fluid flow path 215, placing the actuator 250 in its second state also establishes fluid communication between the inlet 212 and outlet 213 via at least a portion of the fluid flow path 215. For example, in some embodiments, changing the actuator 250 from its first state to its second state can, for example, open or close a port or valve, move one or more seals, move or remove one or more obstructions, define one or more portions of the flow path, and / or so on.

[0147] In some embodiments, the fluid collection device 295 may be fluidly coupled to the outlet 213 before and / or simultaneously with the actuator 250 transitioning from the first state to the second state. As described above, the fluid collection device 295 may be any suitable reservoir, container, and / or device configured to receive a volume of bodily fluid. For example, the fluid collection device 295 may be a vacuum-sealed reservoir or container defining a negative pressure, and / or may be a syringe operable to generate a negative pressure. In some cases, coupling the outlet 213 to the fluid collection device 295 selectively exposes at least a portion of the fluid flow path 215 to the negative pressure and / or suction within the fluid collection device 295. Thus, in response to the negative pressure and / or suction, one or more subsequent volumes of bodily fluid may flow from the inlet 212, through at least a portion of the fluid flow path 215, through the outlet 213, and into the fluid collection device 295. As described above, isolating the initial volume of body fluid (e.g., in the rapid testing device 270) before collecting or acquiring one or more subsequent volumes reduces and / or substantially eliminates a certain amount of contaminants in the one or more subsequent volumes. Therefore, the subsequent volumes of body fluid can be used for one or more tests, such as blood culture tests and / or the like, which may be relatively sensitive to contaminants (e.g., can produce results of contamination due to the presence of contaminants). In this way, the system 200 can be configured to acquire an initial volume of body fluid and one or more subsequent volumes of body fluid, the initial volume of body fluid being used for tests with relatively low sensitivity to contamination, and the subsequent volumes of body fluid being used for tests with relatively high sensitivity to contamination. In some cases, testing the initial volume of body fluid (e.g., via the rapid testing device 270) can provide relatively rapid initial results that may suggest one or more treatment options, while testing one or more subsequent volumes of body fluid can provide more detailed test results that typically require a longer time to form.

[0148] Figure 4This is a schematic diagram of a fluid transfer and measurement system 300 according to an embodiment. The fluid transfer and measurement system 300 (also referred to herein as the "system") may include at least a fluid transfer device 305 and a rapid diagnostic test device 370. In some embodiments, the system 300 may include at least one fluid collection device 395, which may be physically and / or fluidly coupled to the fluid transfer device 305. Parts and / or aspects of the fluid transfer device 305, the rapid diagnostic test device 370, and / or the fluid collection device 395 may be referenced above. Figure 3 The fluid transfer devices 105 and / or 205, the rapid diagnostic testing devices 170 (and / or LFA170A) and / or 270, and / or the fluid collection devices 195 and / or 295 described in detail are similar to and / or substantially the same as those shown in Figure 3. Therefore, these parts and / or aspects will not be described in further detail herein.

[0149] The fluid transfer device 305 (also referred to herein as the “transfer device”) may have any suitable shape, size, and / or configuration. In some embodiments, the transfer device 305 may be configured to draw bodily fluids (e.g., blood) from a patient and allow them to enter and / or pass through the transfer device 305. Furthermore, the transfer device 305 may be configured to transfer at least some of the drawn bodily fluids to one or more other devices, reservoirs, containers, vials, machines, tests, assays, etc., such as the rapid diagnostic testing device 370 and / or one or more fluid collection devices 395.

[0150] The transfer device 305 includes a housing 310, a flow controller 340, and an actuator 350. The housing 310 of the device 305 may have any suitable shape, size, and / or configuration. For example, in some embodiments, the housing 310 may be as described above. Figure 3 The housing 210 is similar to and / or substantially the same. Specifically, the housing 310 has and / or forms an inlet 312 and an outlet 313, defining at least one fluid flow path 315 between them. The inlet 312 can be any suitable inlet or port and can be configured to establish fluid communication between the housing 310 and a source of bodily fluids (e.g., a patient). The outlet 313 can be any suitable outlet or port and can be configured to establish fluid communication between the housing 310 and a fluid collection device 395. Furthermore, the fluid collection device 395 can be similar to or substantially the same as the fluid collection device 295 and therefore will not be described in detail herein. As further described in detail herein, one or more fluid flow paths 315 defined by the housing 310 extend between the inlet 312 and the outlet 313 and can selectively establish fluid communication between them.

[0151] However, housing 310 may differ from housing 210 by including, forming, and / or coupling to isolation chamber 330. As further described herein, isolation chamber 330 is selectively in fluid communication with fluid flow path 315. Additionally, isolation chamber 330 includes, is coupled to, and / or is otherwise in fluid communication with rapid diagnostic testing device 370. As further described herein, isolation chamber 330 may be configured to (1) receive a flow of bodily fluid and / or a volume of bodily fluid from inlet 312, (2) isolate (e.g., separate, isolate, contain, retain, detach, etc.) at least a portion of the flow of bodily fluid and / or a volume of bodily fluid therein, and (3) transfer at least a portion of the flow of bodily fluid and / or a volume of bodily fluid to rapid diagnostic testing device.

[0152] The isolation chamber 330 may have any suitable arrangement, such as those described herein with respect to specific embodiments. For example, in some embodiments, the isolation chamber 330 may be formed at least partially by the housing 310. In other embodiments, the isolation chamber 330 may be a reservoir placed and / or arranged within a portion of the housing 310. In other embodiments, the isolation chamber 330 may be formed and / or defined by a portion of a fluid flow path 315. That is, the housing 310 may define one or more lumens and / or may include one or more lumen-defining devices configured to receive an initial flow or initial volume of bodily fluid from the inlet 312, thereby forming and / or serving as the isolation chamber 330. While examples of isolation chambers are described herein, it should be understood that the transfer device 305 and / or the housing 310 may have isolation chambers arranged in any suitable manner, and therefore, the isolation chamber 330 is not intended to be limited to those shown and described herein.

[0153] The isolation chamber 330 may have any suitable volume and / or fluid capacity. For example, in some embodiments, the isolation chamber 330 may have a volume and / or fluid capacity between about 0.1 mL and about 5.0 mL. In some embodiments, the isolation chamber 330 may have a volume measured based on a certain amount of bodily fluid (e.g., an initial or first volume of bodily fluid) configured to be transferred in the isolation chamber 330. For example, in some embodiments, the isolation chamber 330 may have a volume sufficient to receive an initial volume of bodily fluid as small as one microliter or less (e.g., as small as 20 drops, 10 drops, 5 drops, a single drop, or any suitable volume in between). In other embodiments, the isolation chamber 330 may have a volume sufficient to receive an initial volume of bodily fluid up to, for example, about 5.0 mL, 10.0 mL, 15.0 mL, 20.0 mL, 30.0 mL, 40.0 mL, 50.0 mL, or more. In some embodiments, the volume of the isolation chamber 330 may be equal to at least some of the volume of one or more lumens in fluid communication with the source of bodily fluid (e.g., the combined volume of the lumen of the needle, the inlet 312, and at least a portion of the fluid flow path 315). In other embodiments, the isolation chamber 330 may have a volume at least partially based on the required volume of bodily fluid used in or by the rapid diagnostic test device 370.

[0154] like Figure 4 As shown, device 305 includes a flow controller 340, which is at least partially disposed within housing 310 and configured to control, guide, and / or otherwise facilitate the selective flow of fluid through at least a portion of housing 310, at least a portion of fluid flow path 315, and / or at least a portion of isolation chamber 330. In this document, the fluid flow may be, for example, a liquid such as water, oil, wetting fluid, bodily fluid, and / or any other suitable liquid, and / or a gas such as air, oxygen, carbon dioxide, helium, nitrogen, ethylene oxide, and / or any other suitable gas.

[0155] The flow controller 340 may have any suitable shape, size, and / or configuration. In some embodiments, the flow controller 340 may be, for example, a valve, diaphragm, diaphragm, bladder, plunger, piston, bag, pouch, and / or any other suitable component having the desired stiffness, flexibility, and / or rigidity, or any suitable combination thereof. In some embodiments, the flow controller 340 may be, for example, a flow restrictor, vent, absorbent component, selectively permeable component (e.g., a fluid-impermeable barrier or seal that at least selectively allows air or gas to pass through), port, junction, actuator, and / or the like, or any suitable combination thereof. In some implementations, the flow controller 340 may be similar to or substantially identical to any flow controller described in the following publications: '117 Publication; U.S. Patent Publication No. 2019 / 0076074, filed September 12, 2018, entitled "Fluid Control Devices and Methods of Using the Same" ("'074 Publication"); U.S. Patent Publication No. 2019 / 0365303, filed May 30, 2019, entitled "Fluid Control Devices and Methods of Using the Same" ("'303 Publication"); and / or U.S. Patent Publication No. 2020 / 0289039, filed March 11, 2019, entitled "Fluid Control Devices and Methods of Using the Same" ("'039 Publication"). The disclosures of each publication are incorporated herein by reference in their entirety.

[0156] In some embodiments, the transfer device 305 may be configured to selectively transfer a quantity of bodily fluid to the isolation chamber 330 or outlet 313 based at least in part on a pressure difference between two or more portions of the transfer device 305. For example, the pressure difference may be generated by fluid coupling of outlet 313 with a fluid collection device 395, which may define a negative pressure and / or be configured to generate a negative pressure (e.g., a evacuated reservoir, syringe, pressurized tank, and / or other source or potential energy that generates a vacuum or pressure difference). In other embodiments, the pressure difference may be generated by changes in volume and / or temperature. In other embodiments, the pressure difference may be generated by at least a portion of the transfer device 305, housing 310, actuator 350, and / or a evacuated and / or filled portion of the fluid flow path 315 (e.g., isolation chamber 330 and / or any other suitable portion). In some embodiments, the pressure difference may be established automatically or by direct or indirect intervention (e.g., by a user).

[0157] In some embodiments, the flow controller 340 may be configured to facilitate the displacement of air (or other fluids) through one or more portions of the transmission device 305, which in some cases may allow or result in pressure differentials and / or pressure equalization across one or more portions of the housing 310. Furthermore, the flow of fluids (e.g., gases and / or liquids) generated by the pressure differentials may be selectively controlled by the flow controller 340. For example, the flow controller 340 may be configured to switch between one or more operating states or conditions to control fluid flow. In some embodiments, the flow controller 340 may be a component or device formed of an absorbent or semi-permeable material configured to selectively allow fluid flow. For example, as detailed in '117 publication and / or '380 application, such an absorbent material may be converted from a first state to a second state in which the material allows gas (e.g., air) to flow but prevents liquid (e.g., bodily fluids) to flow, and in a second state in which the material substantially prevents both gas and liquid flow (e.g., the flow controller 340 may be a selectively permeable blood barrier).

[0158] In some embodiments, the flow controller 340 may be configured to transition from a first state to a second state in response to a negative pressure differential and / or suction applied to at least a portion of the flow controller 340. For example, the flow controller 340 may include one or more valves, membranes, diaphragms, and / or the like. For example, before using the device 305, the flow controller 340 may be in a first state (e.g., a stored or unused state), and in response to fluid coupling of outlet 313 to fluid collection device 395 (e.g., a collection device defining or configured to define negative pressure and / or suction), the flow controller 340 may transition to the second state. In some embodiments, as detailed in '380' and / or '477' applications, the flow controller 340 may be an airbag configured to transition from a first state or "flip" to a second state in response to a negative pressure differential and / or suction applied to the surface of the airbag.

[0159] In some embodiments, the size, shape, arrangement, and / or constituent materials of the flow controller 340 may be configured and / or otherwise selected such that the flow controller 340 transitions from a first state to a second state in a predetermined manner and / or at a predetermined or desired rate. In some cases, controlling the rate at which the flow controller 340 transitions from the first state to the second state can further control and / or regulate the rate at which bodily fluid flows into the isolation chamber 330 and / or the magnitude of the suction generated in the isolation chamber 330, which can be used to draw an initial volume of bodily fluid into the isolation chamber 330. Although Figure 4Not shown, in some embodiments, the housing 310 and / or the flow controller 340 may include any suitable components, features, openings, etc., configured to regulate the suction applied to or through the flow controller 340, which in turn regulates the rate at which the flow controller 340 transitions from a first state to a second state. In some cases, controlling the rate of transition of the flow controller 340 and / or the magnitude of the pressure difference and / or suction generated within the isolation chamber 330 can reduce the likelihood of, for example, hemolysis and / or venous collapse in blood samples (this is particularly important, for example, when obtaining body fluid samples from vulnerable patients). In some cases, regulating the transition of the flow controller 340 and / or the pressure difference generated within the isolation chamber 330 can at least partially control the amount or volume of body fluid transferred to the isolation chamber 330 (i.e., the volume of the initial amount of body fluid can be controlled).

[0160] In some embodiments, the flow controller 340 may include any suitable combination of means, components, and / or features. It should be understood that the flow controllers included in the embodiments described herein are presented by way of example and not limitation. Therefore, although particular flow controllers are described herein, it should be understood that fluid flow through the transfer device 305 can be controlled by any suitable means.

[0161] The actuator 350 of device 305 is at least partially disposed within housing 310 and configured to control, guide, and / or otherwise facilitate selective flow of fluid through at least a portion of housing 310 and / or at least a portion of one or more fluid flow paths 315. Actuator 350 may have any suitable shape, size, and / or configuration. In some embodiments, actuator 350 may be a component or device configured to switch between any number of states in any suitable manner. Additionally, actuator 350 may be actuated in any suitable manner (e.g., user actuation, automatic actuation, mechanical actuation, electronic actuation, chemical actuation, and / or etc.). For example, actuator 350 may be similar to and / or substantially identical to any of the actuators described above with reference to actuator 250.

[0162] exist Figure 4In the illustrated embodiment, actuator 350 may be configured to selectively establish fluid communication between inlet 312 and isolation chamber 330 when in a first state, and selectively establish fluid communication between inlet 312 and outlet 313 when in a second state. In the first state, actuator 350 may be configured to allow bodily fluid to flow from inlet 312 through at least a portion of fluid flow path 315 to reach or enter isolation chamber 330. In some embodiments, actuator 350 may be configured to isolate, separate, disconnect, and / or otherwise prevent fluid communication between outlet 313 and inlet 312, at least a portion of fluid flow path 315, and / or isolation chamber 330. In the second state, as further described herein, actuator 350 may be configured to allow subsequent volumes of bodily fluid (e.g., a volume of bodily fluid following the initial volume) to be transferred from inlet 312 through at least a portion of fluid flow path 315 to outlet 313 (and / or fluid collection device 395 fluidly coupled to outlet 313). Additionally, when in the second state, the actuator 350 can be configured to isolate, separate, disconnect, and / or otherwise prevent fluid communication between the isolation chamber 330 and at least a portion of the inlet 312, outlet 313, and / or fluid flow path 315. Figure 4 In the illustrated embodiment, as described in further detail herein, the transfer device 305 enables the actuator 350 and the flow controller 340 to jointly control the flow of fluid (e.g., gas and / or liquid) through the device.

[0163] The rapid diagnostic test apparatus 370 (also referred to herein as a "rapid test apparatus" or simply a "test apparatus") may have any suitable shape, size, and / or configuration. In some embodiments, the rapid test apparatus 370 may be removably coupled to the transmission device 305 or any suitable portion thereof. For example, in Figure 4 In the illustrated embodiment, the rapid test device 370 may be at least fluidly coupled to the isolation chamber of the transmission device 305. In other embodiments, the rapid test device 370 may be integrated into the transmission device 305, such that the rapid test device 370 is in fluid communication with the isolation chamber 330. For example, the transmission device 305 and the rapid test device 370 may be integrally or separately formed and / or otherwise integrated. In other embodiments, the housing 310 may include and / or may form ports, adapters, and / or receiving portions to which the rapid test device 370 may be coupled, or the rapid test device 370 may be inserted into the ports, adapters, and / or receiving portions to establish fluid communication between the rapid test device 370 and the isolation chamber 330.

[0164] In some such implementations, coupling the rapid test device 370 to the transfer device 305 can be used to change one or more flow controllers, valves, diaphragms, ports, seals, etc., from a closed or sealed state to an open state, allowing fluid communication between the transfer device 305 and the test device 370. Although Figure 4 Not shown, but in some embodiments, the transmission device 305 may include a second actuator, etc., that can be manipulated to establish fluid communication between the isolation chamber 330 and the rapid testing device 370. In other embodiments, the actuator 350 may be switched to establish fluid communication between the isolation chamber 330 and the rapid testing device 370.

[0165] In some embodiments, the rapid testing device 370 may be configured to receive a first volume of bodily fluid from the transmission device 305 and use the first volume of bodily fluid to perform one or more tests, assays, and / or diagnostic procedures. The rapid testing device 370 may be any suitable testing device. For example, as referenced above... Figure 2 As detailed in the LFA 170A shown, the rapid test apparatus 370 can be an LFA, etc. In some embodiments, the test apparatus 370 and / or aspects or portions thereof may be substantially similar to the rapid test apparatus 170 and / or 270 described in detail above. Therefore, the rapid test apparatus 370 and / or aspects or portions thereof will not be described in detail herein.

[0166] As described above, system 300 can be used to obtain one or more volumes of bodily fluid from a patient, which can be used for one or more testing, assay, and / or diagnostic procedures. For example, in some cases, as described above, a user such as a physician, internist, nurse, phlebotomist, technician, etc., can manipulate device 305 to establish fluid communication between inlet 312 and a source of bodily fluid (e.g., a patient's vein, cerebrospinal fluid (CSF) from the spinal canal, urine collection, and / or the like). In some cases, when inlet 312 is positioned in fluid communication with a source of bodily fluid (e.g., a portion of the patient), actuator 350 may be in a first state such that at least a portion of fluid flow path 315 establishes fluid communication between inlet 312 and isolation chamber 330.

[0167] Thus, the transfer device 305 can be configured to transfer an initial volume of bodily fluid from a fluid source (e.g., a patient) to the rapid testing device 370. More specifically, in Figure 4In the illustrated embodiments, once inlet 312 is positioned in fluid communication with a source of bodily fluid (e.g., a portion of a patient's fluid), outlet 313 can be fluidly coupled to fluid collection device 395. As described above, in some embodiments, fluid collection device 395 can be any suitable reservoir, container, and / or device configured to receive a quantity of bodily fluid. For example, fluid collection device 395 can be a vacuum-sealed reservoir or container defining a negative pressure, and / or can be a syringe operable to generate negative pressure. In some cases, coupling outlet 313 to fluid collection device 395 selectively exposes at least a portion of fluid flow path 315 to negative pressure and / or suction within fluid collection device 395. In some embodiments, actuator 350 can be in a first state such that outlet 313 is isolated from inlet 312. Additionally, when actuator 350 is in the first state, outlet 313 can be in fluid communication with flow controller 340 (e.g., via a portion of fluid flow path 315). When the fluid collection device 395 is coupled to the outlet 313, the flow controller 340 can similarly be in its first state.

[0168] In embodiments where the flow controller 340 is a selectively permeable component or membrane, the arrangement of the flow controller 340 and actuator 350 allows air or gas flow to be permitted through the flow controller 340 between the outlet 313 and the isolation chamber 330. In such embodiments, as detailed in '117 publication and / or '380 application, this arrangement results in at least a portion of the negative pressure differential or suction generated by the fluid collection device 395 being transferred to and / or through the isolation chamber 330, which in turn can be used to draw an initial volume of bodily fluid from a source through at least a portion of the inlet 312 and the fluid flow path 315 and into the isolation chamber 330.

[0169] Alternatively, in embodiments where the flow controller 340 is a diaphragm, baffle, valve, sleeve, etc., the arrangement of the flow controller 340 and actuator 350 allows a portion and / or surface of the flow controller 340 to be in fluid communication with the outlet 313 (e.g., via a portion of the fluid flow path 315). In this way, negative pressure and / or suction can be applied to a portion and / or surface of the flow controller 340, which can then be used to transition the flow controller 340 from its first state to its second state, in which the isolation chamber 330 has a first volume, and in the second state, the isolation chamber 330 has a second volume greater than the first volume. The increase in volume of the isolation chamber 330 can cause a decrease in pressure within the isolation chamber 330, thereby generating a negative pressure differential that can be used to draw bodily fluids into the isolation chamber 330. Therefore, in such embodiments, as detailed in the '380 application and / or '477 application, in response to the switching of the flow controller 340, an initial volume of body fluid can be drawn into the isolation chamber 330 (e.g., the volume of the isolation chamber 330 increases as the flow controller 340 switches from a first state to a second state).

[0170] The initial volume of the body fluid can be any suitable volume of body fluid, such as any of the volumes or amounts described above. For example, in some cases, the transfer device 305 may remain in a first state or configuration until a predetermined and / or desired volume (e.g., the initial volume) of body fluid is transferred to the isolation chamber 330. In some embodiments, the initial volume may be associated with and / or at least partially based on the volume of the isolation chamber 330 or a portion thereof (e.g., a volume sufficient to fill the isolation chamber 330 or a desired portion of the isolation chamber 330). In some embodiments, the initial volume may be associated with and / or at least partially based on a desired volume sufficient to enable the rapid testing device 370 to perform one or more tests or determinations. In other embodiments, the initial volume of the body fluid may be associated with and / or at least partially based on the amount or volume of body fluid equal to or greater than the volume associated with the fluid flow path defined between the body fluid source and the isolation chamber 330. In other embodiments, the transfer device 305 may be configured to transfer a flow of bodily fluid (e.g., an initial volume) into the isolation chamber 330 until the pressure difference between the isolation chamber 330 and the inlet 312 or the source of bodily fluid is substantially equalized and / or otherwise reduced to below a desired threshold.

[0171] In some embodiments, the transfer device 305 may be configured to transfer a flow of bodily fluid (e.g., an initial volume) into the isolation chamber 330 until the flow controller 340 transitions to its second configuration. In other words, in some embodiments, transferring an initial volume of bodily fluid into the isolation chamber 330 can be used to place the flow controller 340 into its second state or configuration. For example, in embodiments where the flow controller 340 is a selectively permeable component, transferring an initial volume of bodily fluid into the isolation chamber 330 may cause at least a portion of the initial volume to wet and / or saturate the flow controller 340, which in turn places the flow controller 340 into its second state, as detailed in '117 and / or '380 applications. In embodiments where the flow controller 340 is a diaphragm and / or the like, as detailed in '380 and / or '477 applications, the transfer of the initial volume to the isolation chamber 330 may substantially coincide with the flow controller 340 being placed into its second state and / or configuration (e.g., in response to a negative pressure generated by the fluid collection device 395). Furthermore, in Figure 4 In the illustrated embodiment, the flow controller 340 is arranged such that, when in its second state and / or configuration, the flow controller 340 isolates the isolation chamber 330 from the outlet 313 and / or fluidly separates the isolation chamber 330 from the outlet 313, such that the negative pressure and / or suction generated by the fluid collection device 395 no longer act on or pass through the isolation chamber 330.

[0172] In some embodiments, when the flow controller 340 is in its second state and before the actuator transitions from its first state to its second state, at least a portion of the initial volume of fluid may be transferred from the isolation chamber 330 to the rapid testing device 370. In some embodiments, the actuator 350 is configured to isolate the isolation chamber 330 from at least a portion of the inlet 313, outlet 315, and fluid flow path 315. In such embodiments, a portion of the initial volume of fluid may be transferred from the isolation chamber 330 before, during, and / or after the actuator 350 transitions from its first state to its second state. In some embodiments, the transfer of a portion of the initial volume may be automatic. In other embodiments, the transfer of a portion of the initial volume may be in response to one or more user inputs and / or, etc.

[0173] In some embodiments, as described in detail above with reference to rapid testing device 270, transferring a portion of an initial volume of bodily fluid to rapid testing device 370 can initiate testing and / or determination of that portion of the initial volume of bodily fluid. Furthermore, rapid testing device 370 can be configured to perform any suitable test and / or determination. For example, as described in detail above, rapid testing device 370 can be an LFA configured to test for the presence of lactate and / or PCT. Additionally, as described in detail above, once the test or determination is complete, rapid testing device 370 can be configured to output test results that can be detected and / or evaluated by a person and / or one or more electronic devices.

[0174] In some embodiments, the transition of actuator 350 from its first state to its second state (e.g., placing the transfer device 305 in its second state or configuration) can isolate, separate, separate, and / or retain the initial volume of bodily fluid in isolation chamber 330 and / or rapid testing device 370. In other words, actuator 350 can isolate and / or separate isolation chamber 330 from one or more portions of inlet 312, outlet 313, and fluid flow path 315. In some cases, isolating the initial volume of bodily fluid in isolation chamber 330 can also isolate contaminants in the initial volume. Furthermore, as described in detail above, the arrangement of rapid testing device 370 can make the tests and / or measurements performed by rapid testing device 370 less susceptible to such contamination, meaning that the accuracy of the test results output by rapid testing device 370 is not affected by such contamination.

[0175] In addition to isolating the isolation chamber 330 from at least a portion of the inlet 312, outlet 313, and fluid flow path 315, placing the actuator 350 in its second state (and placing the flow controller 340 in its second state) also establishes fluid communication between the inlet 312 and outlet 313 via at least a portion of the fluid flow path 315. For example, in some embodiments, changing the actuator 350 from its first state to its second state can, for example, open or close a port or valve, move one or more seals, move or remove one or more obstructions, define one or more portions of the flow path, and / or so on. Thus, in response to the negative pressure and / or suction generated by the fluid collection device 395, one or more subsequent volumes of body fluid can flow from the inlet 312, through at least a portion of the fluid flow path 315, through the outlet 313, and into the fluid collection device 395. As described above, isolating the initial volume of body fluid (e.g., in the rapid testing device 370) before collecting or acquiring one or more subsequent volumes of body fluid reduces and / or substantially eliminates a certain amount of contaminants in the one or more subsequent volumes. Therefore, system 300 can be configured to acquire an initial volume of body fluid and one or more subsequent volumes of body fluid, the initial volume of body fluid being used for rapid testing with relatively low sensitivity to contamination, and one or more subsequent volumes of body fluid being used for testing with relatively high sensitivity to contamination, as described above with reference to systems 100 and / or 200.

[0176] Figure 5A and Figure 5B This is a schematic diagram of a fluid transfer and measurement system 400 according to an embodiment, shown in a first state and a second state, respectively. The fluid transfer and measurement system 400 (also referred to herein as the "system") may include at least a fluid transfer device 405 and a rapid diagnostic testing device 470. Parts and / or aspects of the fluid transfer device 405 and / or the rapid diagnostic testing device 470 may be similar to and / or substantially identical to the fluid transfer devices 105, 205 and / or 305 and / or the rapid diagnostic testing devices 170 (and / or LFA 170A), 270 and / or 370 described in detail above, respectively. Therefore, these parts and / or aspects will not be described in further detail herein.

[0177] The fluid transfer device 405 (also referred to herein as the “transfer device”) may have any suitable shape, size, and / or configuration. In some embodiments, the transfer device 405 may be configured to draw bodily fluids (e.g., blood) from a patient and allow them to enter and / or pass through the transfer device 405. Additionally, the transfer device 405 may be configured to transfer at least some of the drawn bodily fluids to one or more other devices, reservoirs, containers, vials, machines, tests, assays, etc., such as the rapid diagnostic testing device 470 and / or one or more fluid collection devices (not included in the above description). Figure 5A and Figure 5B (as shown in the image).

[0178] The transfer device 405 includes at least a housing 410 and an actuator 450. The housing 410 of the device 405 may have any suitable shape, size, and / or configuration. For example, in some embodiments, the housing 410 may be similar to and / or substantially the same as the housings 210 and / or 310 described above. Specifically, the housing 410 has and / or forms an inlet 412 and an outlet 413, and may define at least one fluid flow path between them (not shown in the original text). Figure 5A and Figure 5B (As shown in the image). Inlet 412 can be any suitable inlet or port and can be configured to establish fluid communication between housing 410 and a source of bodily fluid (e.g., a patient). Outlet 413 can be any suitable outlet or port and can be configured to establish fluid communication between housing 410 and a fluid collection device (not shown in the image). Figure 5A and Figure 5B (as shown), such as any of those described in detail above. As further described herein, one or more fluid flow paths defined by housing 410 extend between inlet 412 and outlet 413, and fluid communication may be selectively established between them.

[0179] As described above with reference to housing 310 Figure 5A and Figure 5B The illustrated housing 410 includes an isolation chamber 430, forms the isolation chamber 430, and / or is coupled to the isolation chamber 430, which is configured to be selectively positioned in fluid communication with a fluid flow path and / or at least an inlet 412. Additionally, the isolation chamber 430 includes a rapid diagnostic testing device 470, is coupled to the rapid diagnostic testing device 470, and / or is otherwise configured to be in fluid communication with the rapid diagnostic testing device 470. The isolation chamber 430 may have any suitable shape, size, and / or configuration. For example, in some embodiments, the isolation chamber 430 may have a volume and / or fluid capacity between about 0.1 mL and about 5.0 mL. In some embodiments, the isolation chamber 430 may have a volume measured according to the amount of bodily fluid (e.g., the initial or first amount of bodily fluid) configured to be transferred into the isolation chamber 430 and / or configured to be tested by the rapid diagnostic testing device 470. In some embodiments, the isolation chamber 430 and / or at least a portion thereof may be at least in form and / or function similar to those referenced above. Figure 4 The isolation room 330 described is essentially the same. Therefore, this document will not describe any part and / or aspect of isolation room 430 in further detail.

[0180] exist Figure 5A and Figure 5BIn the illustrated embodiment, at least a portion of the isolation chamber 430 may include an absorbent and / or a hydrophilic material 431. Additionally, the isolation chamber 430 includes a sampling portion 435 and an vent 424. The absorbent material 431 may be disposed within a portion of the isolation chamber 430. For example, one or more inner surfaces of the isolation chamber 431 may be lined with and / or formed of the absorbent material 431. Figure 5A and Figure 5B As shown, the isolation chamber 430 is arranged such that the sampling portion 435 of the isolation chamber 430 is downstream of the absorbent material 431 (e.g., temporarily fluidly coupled to the inlet 412 relative to a portion of the isolation chamber 430). In this way, the absorbent material 431 can be configured to receive and / or absorb a first portion or part of the initial volume of body fluid transferred into the isolation chamber 430. In some embodiments, the absorbent material 431 may become saturated after absorbing a predetermined amount or volume of body fluid, such that any additional amount or volume of body fluid transferred into the isolation chamber 430 may flow into the sampling portion 435. As further described in detail herein, the sampling portion 435 of the isolation chamber 430 may be positioned in fluid communication with the rapid diagnostic testing device 470 to transfer a portion of the initial volume of body fluid placed in the sampling portion 435 into the rapid diagnostic testing device 470.

[0181] Vent 424 is coupled to housing 410 and / or isolation chamber 430 and is in fluid communication with the internal volume of isolation chamber 430. Vent 424 may be configured to expel air or gas from isolation chamber 430 and / or otherwise allow air or gas to flow out of isolation chamber 430 when an initial volume of bodily fluid is transferred into isolation chamber 430. In some embodiments, expelling air or gas from isolation chamber 430 (e.g., via vent 424) may reduce the amount of pressure within isolation chamber 430 that would otherwise restrict and / or impede the inflow of bodily fluid into isolation chamber 430. In some embodiments, expelling air or gas through vent 424 may allow the creation of a negative pressure differential that may facilitate the transfer of an initial volume of bodily fluid into isolation chamber 430. Although absorbent material 431 and vent 424 are in Figure 5A and Figure 5B While shown as separate components, in other embodiments, the absorbent material 431 may form one or more vents configured to vent air from the isolation chamber 430 and to absorb a first portion or part of the initial volume. For example, the absorbent material 431 may form one or more walls or portions of the walls of the isolation chamber 430.

[0182] The actuator 450 of device 405 may have any suitable shape, size, and / or configuration. In some embodiments, actuator 450 and / or aspects or portions thereof may be similar to and / or substantially identical to actuators 150, 250, and / or 350 described in detail above. In some embodiments, actuator 450 may be at least partially disposed within and / or partially formed by housing 410. As described above, actuator 450 may be configured to control, guide, and / or otherwise facilitate the selective flow of fluid through at least a portion of housing 410 and / or at least a portion of one or more fluid flow paths. In some embodiments, actuator 450 may be a component or device configured to switch between any number of states (e.g., two, three, four, or more) in any suitable manner (e.g., user actuation, automatic actuation, mechanical actuation, electronic actuation, chemical actuation, and / or etc.).

[0183] More specifically, in Figure 5A and Figure 5B In the illustrated embodiment, actuator 450 can be configured to switch between a first state and a second state, in which inlet 412 is in fluid communication with isolation chamber 430. Figure 5A In the second state, inlet 412 and outlet 413 are in fluid communication. Figure 5B In some embodiments, actuator 450, in a first state, may be configured to isolate, separate, disconnect, and / or otherwise prevent fluid communication between outlet 413 and inlet 412 and / or between outlet 413 and isolation chamber 430. Conversely, in a second state, actuator 450 may be configured to allow subsequent volumes of body fluid (e.g., volumes of body fluid following the initial volume) from inlet 412 through one or more fluid flow paths (not in...). Figure 5A and Figure 5B (As shown in the image) fluid is transferred to outlet 413 (and / or a fluid collection device fluidly coupled to outlet 413). Additionally, when in the second state, actuator 450 can be configured to isolate, separate, disconnect, and / or otherwise prevent fluid communication between isolation chamber 430 and inlet 412, isolation chamber 430 and outlet 413, and / or isolation chamber 430 and at least a portion of the fluid flow path extending between inlet 412 and outlet 413. Thus, actuator 450 can be structurally and / or functionally similar to actuators 150, 250, and / or 350 described in detail above.

[0184] The rapid diagnostic test device 470 (also referred to herein as a "rapid test device" or simply a "test device") may have any suitable shape, size, and / or configuration. In some embodiments, the rapid test device 470 may be removably coupled to the transmission device 405 or any suitable portion thereof. For example, in Figure 5Aand Figure 5B In the illustrated embodiments, the rapid testing device 470 may be configured to engage or couple to the housing 410 and / or the isolation chamber 4350, such that the rapid testing device 470 is positioned in fluid communication with the sampling portion 435 of the isolation chamber 430. In some embodiments, the housing 410 may include and / or form ports, adapters, and / or receiving portions to which the rapid testing device 470 may be coupled, or the rapid testing device 470 may be inserted into the ports, adapters, and / or receiving portions to establish fluid communication between the rapid testing device 470 and the sampling portion 435 of the isolation chamber 430. Furthermore, in Figure 5A and Figure 5B In the illustrated embodiments, switching actuator 450 from its first state to its second state can establish fluid communication between isolation chamber 430 and rapid testing device 470 (e.g., via one or more flow controllers, valves, diaphragms, ports, seals, aligned flow paths, and / or other suitable components or devices for establishing fluid communication). In some embodiments, switching actuator 450 from its first state to its second state can establish fluid communication between isolation chamber 430 and rapid testing device 470.

[0185] In some embodiments, the rapid testing device 470 may be configured to receive a first volume of bodily fluid from the sampling portion 435 of the isolation chamber 430 and use the first volume of bodily fluid to perform one or more tests, assays, and / or diagnostic procedures. The rapid testing device 470 can be any suitable testing device. For example, as referenced above... Figure 2 As detailed in the LFA 170A shown, the rapid test apparatus 470 can be an LFA, etc. In some embodiments, the test apparatus 470 and / or aspects or portions thereof may be substantially similar to the rapid test apparatuses 170, 270, and / or 370 described in detail above. Therefore, the rapid test apparatus 470 and / or aspects or portions thereof will not be described in detail herein.

[0186] System 400 can be used to obtain one or more volumes of bodily fluid from a patient, which can be used for one or more testing, assay, and / or diagnostic procedures. As described above, for example, inlet 412 can be positioned in fluid communication with a source of bodily fluid. In some cases, such as Figure 5AAs shown, when inlet 412 is positioned in fluid communication with a source of bodily fluid (e.g., a portion of a patient), actuator 450 may be in a first state, thereby establishing fluid communication between inlet 412 and isolation chamber 430 and isolating outlet 413 from inlet 412. Thus, transfer device 405 may be configured to transfer an initial volume of bodily fluid from the source of bodily fluid (e.g., the patient) to rapid testing device 470. In some embodiments, the initial volume of bodily fluid may flow into and / or into isolation chamber 430 in response to a pressure difference between isolation chamber 430 and inlet 412 and / or the source of bodily fluid. In some embodiments, vent 424 may be configured to allow air or gas to flow out of isolation chamber 430, which may facilitate the inflow of the initial volume of bodily fluid into isolation chamber 430. In some embodiments, vent 424 may be configured to vent isolation chamber 430 in a manner similar to, for example, the vent described in '117 disclosure and / or others.

[0187] The initial volume of body fluid can be any suitable volume of body fluid, such as any of the volumes or amounts mentioned above. More specifically, in Figure 5A and Figure 5B In the illustrated embodiments, the initial volume of body fluid is sufficient to saturate and / or wet (or substantially saturate and / or wet) the absorbent material 431 placed in the isolation chamber 430, and sufficient to fill (or substantially fill) the sampling portion 435 of the isolation chamber 430. In some embodiments, the filling of the isolation chamber 430 may be continuous, as the initial volume of body fluid is first absorbed by the absorbent material 431 until the absorbent material 431 is saturated, and then the remaining portion of the initial volume of body fluid may flow into and / or fill the sampling portion 435 of the isolation chamber 430. In some embodiments, continuous filling of the isolation chamber 430 may allow a portion of the initial volume of body fluid (e.g., a first portion) to contain contaminants (e.g., those associated with and / or generated by venipuncture events, fluid-coupled to one or more components, etc.), while a portion of the initial volume of body fluid (e.g., a second portion) may contain a reduced amount of contaminants and / or may be substantially free of contaminants. In some cases, once the initial volume of body fluid has been transferred into the isolation chamber 430, the flow of body fluid can be stopped and / or the pressure differential can be substantially equalized, which can slow down or stop the flow of body fluid.

[0188] In some implementations, after the initial volume of bodily fluid is transferred into the isolation chamber 430, the actuator 450 can be released from its first state ( Figure 5A ) transforms into its second state ( Figure 5BFor example, in some embodiments, actuator 450 may be moved, slidable, switched, rotated, and / or otherwise converted relative to inlet 412 and outlet 413. In some embodiments, switching and / or moving actuator 450 may include switching and / or moving at least a portion of housing 410. In other embodiments, actuator 450 may be moved relative to housing 410 (e.g., housing 410 need not be switched and / or moved).

[0189] like Figure 5B As shown, switching actuator 450 from a first state to a second state can establish fluid communication between the sampling portion 435 of the isolation chamber 430 and the rapid testing device 470, and can isolate the isolation chamber 430 from one or more portions of the inlet 412, outlet 413 and / or the fluid flow path therebetween. In some embodiments, the actuator 450 is arranged such that placing the actuator 450 in the second state results in and / or increases the air gap between a portion of the isolation chamber 430 comprising absorbent material 431 and a portion of the isolation chamber 430 comprising, forming and / or defining the sampling portion 435. The air gap can facilitate the transfer of bodily fluids from the sampling portion 435 to the rapid testing device 470 (e.g., by allowing a desired relative pressure or pressure difference). Additionally, in cases where contaminants are contained in a portion of the initial volume absorbed by absorbent material 431, this arrangement can ensure that only a portion of the initial volume placed in the sampling portion 435 of the isolation chamber 430 is transferred to the rapid testing device 470.

[0190] When actuator 450 transitions from its first state to its second state, at least a portion of the initial volume of fluid can be transferred from the sampling portion 435 of isolation chamber 430 to rapid testing device 470. In some embodiments, the transfer of a portion of the initial volume can be automatic. In other embodiments, the transfer of a portion of the initial volume can be in response to one or more user inputs and / or, etc. In some embodiments, placing actuator 450 in the second state can fluidly couple rapid testing device 470 to the sampling portion 435 of isolation chamber 430, thereby allowing fluid to transfer between them.

[0191] In some embodiments, as described in detail above with reference to rapid testing device 270, transferring a portion of the initial volume of bodily fluid to rapid testing device 470 can initiate testing and / or determination of that portion of the initial volume of bodily fluid. In some cases, such as Figure 5BAs shown, system 400, delivery device 405, and / or rapid testing device 470 can be configured to provide buffer solution 481 (or any other suitable solution) which can be mixed with a portion of the initial volume of body fluid. Rapid testing device 470 can be configured to perform any suitable test and / or assay. For example, as described in detail above, rapid testing device 470 can be an LFA configured to test for the presence of lactate and / or PCT. Furthermore, once the test or assay is complete, rapid testing device 470 can be configured to output test results that can be detected and / or evaluated by a person and / or one or more electronic devices, as described in detail above with reference to rapid testing devices 170, 270, and / or 370.

[0192] Transitioning actuator 450 from its first state to its second state can isolate, separate, separate, and / or retain the initial volume of liquid within isolation chamber 430 and / or rapid testing device 470. In other words, actuator 450 can isolate and / or separate isolation chamber 430 from inlet 412, outlet 413, and one or more portions of the fluid flow path. In some cases, isolating the initial volume of bodily fluid within isolation chamber 430 can also isolate contaminants in the initial volume (e.g., at least a portion of the initial volume absorbed by absorbent material 431). Furthermore, as described in detail above, the arrangement of rapid testing device 470 can make the tests and / or measurements performed by rapid testing device 470 less susceptible to such contamination, meaning the accuracy of test results output by rapid testing device 470 is unaffected by such contamination. In other cases, the absorption of a first portion or part of the initial volume of bodily fluid by absorbent material 431 can allow rapid testing device 470 to perform one or more tests that may be at least partially sensitive to contaminants.

[0193] Additionally, converting actuator 450 to its second state establishes fluid communication between inlet 412 and outlet 413 via at least a portion of a fluid flow path disposed between inlet 412 and outlet 413. For example, converting actuator 450 from its first state to its second state may involve opening or closing a port or valve, moving one or more seals, moving or removing one or more obstructions, defining one or more portions of a flow path, and / or so on. In some embodiments, outlet 413 may be placed in fluid communication with a fluid collection device before or after the actuator is placed in its second state. As described in detail above, the fluid collection device may define negative pressure and / or suction and / or may be configured to generate negative pressure and / or suction, which can be used to draw bodily fluids into the fluid collection device. Thus, in response to negative pressure and / or suction, one or more subsequent volumes of bodily fluid may flow from inlet 412, through any suitable fluid flow path or a portion thereof, through outlet 413 into the fluid collection device. As described above, isolating the initial volume of body fluid in isolation chamber 430 before collecting or acquiring one or more subsequent volumes reduces and / or substantially eliminates the amount of contaminants in one or more subsequent volumes. Therefore, as described above with reference to systems 100, 200, and / or 300, system 400 can be configured to acquire an initial volume of body fluid and one or more subsequent volumes of body fluid, the initial volume of body fluid being used for one or more rapid testing procedures, and the subsequent volumes of body fluid being used for tests with relatively high sensitivity to contamination (e.g., blood culture tests).

[0194] Figures 6A to 6D This is a schematic diagram of a fluid transfer and measurement system 500 according to at least a portion of an embodiment. The fluid transfer and measurement system 500 (also referred to herein as the "system") may include at least a fluid transfer device 505 and a rapid diagnostic testing device 570. Parts and / or aspects of the fluid transfer device 505 and / or the rapid diagnostic testing device 570 may be similar to and / or substantially identical to the fluid transfer devices 105, 205, 305 and / or 405 and / or the rapid diagnostic testing devices 170 (and / or LFA 170A), 270, 370 and / or 470 described in detail above. Therefore, these parts and / or aspects will not be described in further detail herein.

[0195] The fluid transfer device 505 (also referred to herein as the “transfer device”) may have any suitable shape, size, and / or configuration. In some embodiments, the transfer device 505 may be configured to draw bodily fluids (e.g., blood) from a patient and allow them to enter and / or pass through the transfer device 505. Additionally, the transfer device 505 may be configured to transfer at least some of the drawn bodily fluids to one or more other devices, reservoirs, containers, vials, machines, tests, assays, etc., such as the rapid diagnostic testing device 570 and / or one or more fluid collection devices (not included in the above description). Figures 6A-6D (as shown in the image). Transmission device 505 and / or aspects or parts thereof may be substantially similar to any of the transmission devices 105, 205, 305 and / or 405 described in detail above. Therefore, transmission device 505 will not be described in detail herein.

[0196] The rapid diagnostic test apparatus 570 (also referred to herein as the "rapid test apparatus" or simply the "test apparatus") can be any suitable test apparatus. In some embodiments, the test apparatus 570 and / or aspects or portions thereof may be substantially similar to the rapid test apparatus 170 (and / or LFA 170A), 270, 370 and / or 470 described in detail above. Therefore, the rapid test apparatus 570 and / or aspects or portions thereof will not be described in detail herein.

[0197] exist Figures 6A to 6D The implementation scheme shown above refers to... Figure 2 As detailed in the LFA170A illustration, the rapid testing device 570 can be an LFA or similar device. The rapid testing device 570 includes a substrate 571 having any suitable capillary bed or similar configuration, as described above. Additionally, the rapid testing device 570 includes a coupling member 578, which can be coupled to the substrate 571 via an attachment mechanism 579. The coupling member 578 can be any suitable coupling member configured to establish fluid communication with the internal volume of the transmission device 505 in response to the rapid testing device 570 being coupled to the transmission device 505. For example, as... Figure 6A and Figure 6BAs shown, the rapid testing device 570 and / or its coupling member 578 may be configured to be coupled to the transmission device 505 via a port 525 (e.g., any suitable port, vent, coupler, opening, valve, connector, etc.). In some embodiments, the coupling member 578 may be, for example, a puncture member, needle, tube, etc., which may puncture and / or otherwise advance through the port 525. In some embodiments, the coupling member 578 may be a capillary member, etc., configured to transmit fluid via capillary action. In some embodiments, the port 525 may be self-healing, and the port 525 may seal once the coupling portion 578 of the rapid testing device 570 is removed from the port 525. In some embodiments, the port 525 and / or at least a portion thereof may include and / or may form a vent similar to vent 424.

[0198] The attachment mechanism 579 can be any suitable component, mechanism, device, etc., configured to attach the coupling member 578 to the substrate 571. In some embodiments, the attachment mechanism 579 can be configured to switch between two or more states or configurations to selectively position the coupling member 578 in fluid communication with a portion of the substrate 571 (e.g., a sample portion, element, and / or capillary bed). More specifically, the attachment mechanism 579 can be configured in a first state and / or configuration ( Figures 6A-6C ) with the second state and / or configuration ( Figure 6D Convert between )

[0199] In the first state, the rapid testing device 570 can be coupled to the transmission device 505, and the coupling portion 578 can establish fluid communication with the internal volume of the transmission device 505 (e.g., through port 525). Figure 6B As shown, the coupling member 578 can receive at least a portion of the volume of bodily fluid disposed in the transmission device 505 (e.g., via capillary action, pressure differential, and / or any other fluid transfer mode). Figure 6C and Figure 6D As shown, once the coupling member 578 has received the required volume of body fluid, the rapid testing device 570 can be decoupled from the transmission device 505, and the attachment mechanism 579 can transition from its first state to its second state.

[0200] For example, in some embodiments, the attachment mechanism 579 may be a movable hinge capable of bending, folding, deforming, and / or otherwise reconfiguring. When the attachment mechanism 579 is in the second state, the coupling member 578 may be in fluid communication with a portion of the substrate 571 (e.g., a sample portion, element, and / or capillary bed), such as... Figure 6DAs shown. Therefore, the volume of bodily fluid contained in coupling member 578 can be transferred to a portion of substrate 571. Additionally, in some embodiments, when attachment mechanism 579 is in the second state, buffer solution 581 and / or any other suitable solution can be transferred to substrate 571. Buffer solution 581 can be transferred to substrate 571 through coupling member 578, any suitable portion of attachment mechanism 579, and / or any other suitable portion of rapid testing device 570. In this way, buffer solution 581 can be mixed with a volume of bodily fluid, and the mixture can flow along substrate 571 for testing, as described in detail above. In some embodiments, rapid testing device 570 can be configured to test for the presence of lactate and / or PCT, the presence of which can indicate patient conditions such as sepsis. Furthermore, as described in detail above with reference to rapid testing devices 170, 270, 370 and / or 470, once the test or measurement is completed, rapid testing device 570 can be configured to output test results that can be detected and / or evaluated by a person and / or one or more electronic devices.

[0201] 7A to 7D This is a schematic diagram of a fluid transfer and measurement system 600 according to an embodiment. The fluid transfer and measurement system 600 (also referred to herein as the "system") may include at least a fluid transfer device 605 and a rapid diagnostic testing device 670. Parts and / or aspects of the fluid transfer device 605 and / or the rapid diagnostic testing device 670 may be similar to and / or substantially identical to the fluid transfer devices 105, 205, 305, 405 and / or 505 and / or the rapid diagnostic testing devices 170 (and / or LFA170A), 270, 370, 470 and / or 570 described in detail above. Therefore, these parts and / or aspects will not be described in further detail herein.

[0202] The fluid transfer device 605 (also referred to herein as the “transfer device”) may have any suitable shape, size, and / or configuration. In some embodiments, the transfer device 605 may be configured to draw bodily fluids (e.g., blood) from a patient and allow them to enter and / or pass through the transfer device 605. Additionally, the transfer device 605 may be configured to transfer at least some of the drawn bodily fluids to one or more other devices, reservoirs, containers, vials, machines, tests, assays, etc., such as the rapid diagnostic testing device 670 and / or one or more fluid collection devices (not included in the above description). Figures 7A-7D (as shown in the image).

[0203] The transfer device 605 includes at least a housing 610 and an actuator 650. The housing 610 of the device 605 may have any suitable shape, size, and / or configuration. For example, in some embodiments, the housing 610 may be similar to and / or substantially the same as the housings 210, 310, and / or 410 described above. Specifically, the housing 610 has and / or forms an inlet 612 and an outlet 613, and may define a fluid flow path 615 between them. The inlet 612 may be any suitable inlet or port and may be configured to establish fluid communication between the housing 610 and a source of bodily fluids (e.g., a patient). The outlet 613 may be any suitable outlet or port and may be configured to establish fluid communication between the housing 610 and a fluid collection device (not in...). Figures 7A-7D (as shown in the image), such as any of those described in detail above. As further described herein, the fluid flow path 615 defined by the housing 610 extends between the inlet 612 and the outlet 613, and fluid communication may be selectively established between them.

[0204] As described above with reference to housing 410 Figures 7A-7D The illustrated housing 610 includes, forms, and / or is coupled to an isolation chamber 630, which is configured to be selectively positioned in fluid communication with a fluid flow path and / or at least an inlet 612. Additionally, the isolation chamber 630 includes, forms, and / or defines a sampling portion 635 and a port 625. The isolation chamber 630 may have any suitable shape, size, and / or configuration. For example, in some embodiments, the isolation chamber 630 and / or at least a portion thereof may be substantially similar in form and / or function to the isolation chambers 330 and / or 430 described in detail above. Therefore, further detailed descriptions of parts and / or aspects of the isolation chamber 630 are not provided herein.

[0205] Port 625 is coupled to housing 610 and / or isolation chamber 630 and is in fluid communication with the internal volume of isolation chamber 630. More specifically, as Figures 7A-7D As shown, port 625 is contained within and / or coupled to housing 610 and is in fluid communication with sampling portion 635 of isolation chamber 630. In some embodiments, as described above in detail with reference to vent 424, port 625 and / or at least a portion thereof may be configured to expel air or gas from isolation chamber 630 and / or otherwise allow air or gas to flow out of isolation chamber 630 when an initial volume of bodily fluid is transferred into isolation chamber 630. Sampling portion 635 of isolation chamber 630 may be positioned in fluid communication with rapid diagnostic testing device 670 to transfer a portion of an initial volume of bodily fluid placed in sampling portion 635 to rapid diagnostic testing device 670. Figures 7A-7D The implementation scheme shown above is referenced. Figure 6A and Figure 6BAs described by port 525 shown, the rapid diagnostic test device 670 can be positioned to be in fluid communication with the sampling section 635 via port 625 and / or any other suitable port.

[0206] The actuator 650 of device 605 may have any suitable shape, size, and / or configuration. In some embodiments, actuator 650 and / or aspects or portions thereof may be similar to and / or substantially identical to actuators 150, 250, 350, and / or 450 described in detail above. In some embodiments, actuator 650 may be at least partially disposed within and / or partially formed by housing 610. As described above, actuator 650 may be configured to control, guide, and / or otherwise facilitate the selective flow of fluid through at least a portion of housing 610 and / or at least a portion of one or more fluid flow paths. Actuator 650 may be any one or more suitable components or devices configured to switch between any number of states (e.g., two, three, four, or more) in any suitable manner (e.g., user actuation, automatic actuation, mechanical actuation, electronic actuation, chemical actuation, etc.).

[0207] More specifically, in Figures 7A-7D In the illustrated embodiment, actuator 650 includes a first member 651 and a second member 660. The first member 651 of actuator 650 may have any suitable shape, size, and / or configuration. The first member 651 may be a plunger or the like having at least one seal 652 (e.g., disposed at the end of the first member 651). In some embodiments, the end of the first member 651 may, for example, separate and / or at least partially define a sampling portion 635 of isolation chamber 630. For example, the sampling portion 635 of isolation chamber 630 may be disposed on one side of the end of the first member 651, while the remainder of isolation chamber 630 is disposed on the opposite side of the end of the first member 651. Furthermore, the arrangement of the seal 652 may allow the seal 652 to engage and / or contact the inner surface of housing 610 to form and / or define a substantially fluid-impermeable seal therebetween. The first component 651 also includes one or more valves, ports, openings, channels, selective permeation components, etc. (referred to herein as “valve 653”), which are configured to establish selective fluid communication between the sampling portion 635 of the isolation chamber 635 and the remainder of the isolation chamber 630, as further described in detail herein.

[0208] The second component 660 of the actuator 650 can have any suitable shape, size, and / or configuration. For example, in Figures 7A-7DIn the illustrated embodiment, a second member 660 may be disposed around and / or over at least a portion of the first member 651. The second member 660 includes a set of seals 661. More specifically, the second member 660 may include a set of three seals. As shown, the second member 660 may have a first end and a second end opposite the first end. The first end of the second member 660 includes an outer seal 661 configured to engage and / or contact the inner surface of the housing 610 to define a substantially fluid-impermeable seal therebetween. Additionally, the first end of the second member 660 includes an inner seal 661 configured to engage and / or contact a portion of the first member 651 to define a substantially fluid-impermeable seal therebetween. The second end of the second member 660 includes an outer seal 661 configured to engage and / or contact the inner surface of the housing to define a substantially fluid-impermeable seal therebetween.

[0209] like Figures 7A-7D As shown, the arrangement of the first component 651 and the second component 660 of the actuator is such that a portion of the isolation chamber 630 (e.g., the portion other than the sampling portion 635) is disposed and / or defined between, for example, an end of the first component 651 and a first end of the second component 660. Additionally, the second component 660 is configured to at least partially define a fluid flow path 615 between the first and second ends of the second component 660. Thus, the first end of the second component 660 and the seal 661 (included in the first end) isolate and / or separate the isolation chamber 630 from the fluid flow path 615.

[0210] Actuator 650 is configured to transition between at least a first state, a second state, and a third state. For example... Figures 7A-7D As shown, regardless of the state of actuator 650, the end of the first member 651 and the seal 652 included therein are disposed on and retained thereon on the first side of inlet 612 and the first side of outlet 613. Similarly, regardless of the state of actuator 650, the second end of the second member 660 and the seal 661 included therein are disposed on and retained thereon on the second side of inlet 612 (opposite to the first side) and the second side of outlet 613 (opposite to the first side). However, the first end of the second member 660 and the seal 661 disposed therein are configured such that: (i) when actuator 650 is in the first state and the second state ( Figure 7A and Figure 7B ), and is located on the second side of inlet 612 and the first side of outlet 613, and (ii) when actuator 650 is in the third state ( Figure 7C and 7DThe actuator 650 is disposed on the first side of inlet 612 and the first side of outlet 613. Therefore, as described in further detail herein, the arrangement of the actuator 650 allows the switching actuator 650 to selectively guide and / or switch (i) the fluid flow between inlet 612 and isolation chamber 630 and (ii) the fluid flow between inlet 612 and outlet 613 via fluid flow path 615.

[0211] The rapid diagnostic test apparatus 670 (also referred to herein as the "rapid test apparatus" or simply the "test apparatus") can be any suitable test apparatus. For example, as referenced above... Figure 2 As detailed in the LFA 170A shown, the rapid test apparatus 670 can be an LFA, etc. In some embodiments, the test apparatus 670 and / or aspects or portions thereof may be substantially similar to the rapid test apparatuses 170, 270, 370 and / or 470 described in detail above. Therefore, the rapid test apparatus 670 and / or aspects or portions thereof will not be described in detail herein.

[0212] like Figure 7D As shown, the rapid testing device 670 can be configured to engage or couple to the housing 610 via port 625. In some embodiments, for example, port 625 can be a valve, coupler, and / or any suitable reconfigurable component or device configured to (i) vent air or gas from the isolation chamber 630, as described above with reference to exhaust port 424, and (ii) receive a portion of the rapid testing device 670 to position the rapid testing device 670 in fluid communication with the sampling portion 635 of the isolation chamber 630. For example, the rapid testing device 670 may include a coupling member 678 that, when coupled to the rapid testing device 670, can establish fluid communication with the sampling portion 635 of the isolation chamber 630. In some embodiments, the coupling member 678 can be, for example, a puncture member, needle, tube, capillary, etc., capable of piercing and / or otherwise advancing through port 625. In some embodiments, the coupling member 678 can be coupled to the sample portion 635 of the isolation chamber 630 as described above with reference to the sample portion 635. Figures 6A-6D The described coupling member 578 is substantially similar. In some embodiments, port 625 may be self-healing, meaning that port 625 can be sealed once the coupling portion 678 of the test device 670 is removed from port 625. Figure 7D As shown, the coupling portion 678 of the test device 670 can be coupled to the substrate 671 of the test device 670 (e.g., directly coupled to the substrate 671 and / or coupled via an attachment mechanism such as attachment mechanism 579). In this way, the coupling portion 678 can transfer a volume of body fluid from the sampling portion 635 of the isolation chamber 630 to the test device 670. In response, the test device 670 can use this volume of body fluid to perform one or more test, measurement, and / or diagnostic procedures.

[0213] System 600 can be used to obtain one or more volumes of bodily fluid from a patient, which can be used for one or more testing, assay, and / or diagnostic procedures. As described above, for example, inlet 612 can be positioned in fluid communication with a source of bodily fluid. Figure 7A As shown, when inlet 612 is positioned in fluid communication with a source of bodily fluid (e.g., a portion of a patient's body), actuator 650 can be in a first state, thereby establishing fluid communication between inlet 612 and isolation chamber 630 and isolating outlet 613 from inlet 612. Furthermore, when actuator 650 is in the first state, the end of first member 651 can be close to or adjacent to a first side of inlet 612, and the first end of second member 660 can be close to or adjacent to a second side of inlet 612. In this way, a portion of isolation chamber 630 defined between first member 651 and second member 660 can have a first volume.

[0214] In some cases, once the inlet 612 is positioned in fluid communication with a bodily fluid source, the actuator 650 can transition from its first state to its second state. For example, as Figure 7B As shown, the first component 651 can be transferred or moved relative to the inlet 612 and the second component 660, which further increases the volume of the portion of the isolation chamber 630 disposed between the first component 651 and the second component 660. Additionally, the transfer and / or movement of the first component 651 can reduce the volume of the sampling portion 635 of the isolation chamber 630, and the arrangement of the port 625 allows air or gas contained in the sampling portion 635 to escape and / or flow out of the sampling portion 635. The end of the first component 651 can be configured to restrict and / or substantially prevent air from flowing from the sampling portion 635 of the isolation chamber 630 into the remainder of the isolation chamber 630, such that the increased volume within the remainder of the isolation chamber 630 results in a negative pressure differential, which effectively draws an initial volume of bodily fluid from the fluid source through the inlet 612 and directs it into the isolation chamber 630, as... Figure 7B As shown.

[0215] The initial volume of bodily fluid can be any suitable volume, such as any of the volumes or amounts described above. In some embodiments, once the initial volume of bodily fluid has been transferred into the isolation chamber 630, the flow of the fluid can be stopped and / or the pressure differential can be made substantially equal, which can slow down or stop the flow of the fluid. In such embodiments, the actuator 650 can then transition from its second state to its third state. In other embodiments, the transition of the actuator 650 through the three states can be substantially continuous. In this embodiment, the initial volume of bodily fluid can be the amount of bodily fluid transferred into the isolation chamber 630 when the actuator 650 transitions from its first state to its second state, and continuing to transition the actuator 650 from its second state to its third state can be used to stop the flow into the isolation chamber 630.

[0216] When the initial volume of bodily fluid is contained in the isolator 630, the actuator 650 can transition from its second state to its third state. For example... Figure 7C As shown, converting actuator 650 to a third state may include transferring and / or moving a second member 660 relative to the inlet 612 and the first member 651 of actuator 650. The transfer and / or movement of the second member 660 moves a first end of the second member from the second side of inlet 612 and / or to the first side of inlet 612, thereby isolating and / or separating the isolation chamber 630 from inlet 612. Furthermore, the transfer and / or movement of the second member 660 relative to the first member 651 may reduce the volume of a portion of the isolation chamber 630 disposed therebetween. In some embodiments, such as... Figure 7C As shown, the reduced volume of this portion of the isolation chamber 630 results in an increase in pressure, which can be used to switch valve 653 from a closed state to an open state, thereby allowing at least some of the initial volume of body fluid to be transferred to the sampling portion 635 of the isolation chamber 630.

[0217] like Figure 7D As shown, the rapid testing device 670 may be coupled to the housing 610 and / or otherwise positioned in fluid communication with the sampling portion 635 of the isolation chamber 630 (e.g., via coupling member 678). Therefore, at least a portion of the body fluid can be transferred from the sampling portion 635 of the isolation chamber 630 into the rapid testing device 670. In some embodiments, the transfer of a portion of the initial volume may be automatic. In other embodiments, the transfer of a portion of the initial volume may be in response to one or more user inputs, etc. (e.g., via actuator 650 and / or...). Figures 7A-7D (No other suitable actuating mechanism is shown in the text). In some embodiments, as described above with reference to rapid testing device 270, transferring a portion of the initial volume of body fluid to rapid testing device 670 can initiate testing and / or determination of that portion of the initial volume of body fluid. Although Figures 7A-7D Not shown, but in some cases, system 600, transmission device 605, and / or rapid testing device 670 may be configured to provide a buffer solution (or any other suitable solution) that can be mixed with the initial volume of body fluid. Rapid testing device 670 may be configured to perform any suitable test and / or assay. For example, as described in detail above, rapid testing device 670 may be an LFA configured to test for the presence of lactate and / or PCT. Furthermore, as described in detail above with reference to rapid testing devices 170, 270, 370, and / or 470, once the test or assay is complete, rapid testing device 670 may be configured to output test results that can be detected and / or evaluated by a person and / or one or more electronic devices.

[0218] As described above, switching actuator 650 from its second state to its third state can isolate, separate, isolate, and / or retain the initial volume of bodily fluids within the isolation chamber 630 and / or the rapid testing device 670, which in turn isolates contaminants from the initial volume. Furthermore, as described in detail above, the arrangement of the rapid testing device 670 makes the tests and / or measurements performed by the rapid testing device 670 less susceptible to such contamination, meaning that the accuracy of the test results output by the rapid testing device 670 is unaffected by such contamination.

[0219] like Figure 7C and Figure 7D As shown, the actuator 650 is transitioned from its second state to its third state via a fluid flow path 615 disposed between the first and second ends of the second member 660 of the actuator 650, establishing fluid communication between the inlet 612 and the outlet 613. More specifically, when the actuator 650 is in its third state, the first end of the second member 660 is disposed on the first side of the inlet 612, and the second end of the second member 660 is disposed on the second side of the outlet 613. In other words, both the inlet 612 and the outlet 613 are disposed between the first and second ends of the second member 660. Therefore, when the actuator 650 is in the third state, the fluid flow path 615 can establish fluid communication between the inlet 612 and the outlet 613.

[0220] In some embodiments, before or after the actuator 650 is placed in its third state, the outlet 613 may be positioned in fluid communication with the fluid collection device (not in...). Figures 7A-7D (As shown in the diagram). As described in detail above, the fluid collection device may define negative pressure and / or suction and / or may be configured to generate negative pressure and / or suction, which can be used to draw bodily fluids into the fluid collection device. Thus, in response to negative pressure and / or suction, one or more subsequent volumes of bodily fluid may flow from inlet 612, through fluid flow path 615, through outlet 613, and into the fluid collection device. As described above, isolating the initial volume of bodily fluid in isolation chamber 630 before collecting or acquiring one or more subsequent volumes of bodily fluid reduces and / or substantially eliminates the amount of contaminants in one or more subsequent volumes. Thus, system 600 may be configured to acquire an initial volume of bodily fluid and one or more subsequent volumes of bodily fluid, the initial volume of bodily fluid being used for rapid testing with relatively low sensitivity to contamination, and the subsequent volumes of bodily fluid being used for testing with relatively high sensitivity to contamination, as described above with reference to systems 100, 200, 300, and / or 400.

[0221] Figure 8 and Figures 9A-9DA fluid transfer and measurement system 700 according to an embodiment is shown. The fluid transfer and measurement system 700 (also referred to herein as the “system”) may include at least a fluid transfer device 705 and a rapid diagnostic testing device 770. Parts and / or aspects of the fluid transfer device 705 and / or the rapid diagnostic testing device 770 may be similar to and / or substantially identical to the fluid transfer devices 105, 205, 305, 405, 505 and / or 605, and / or the rapid diagnostic testing devices 170 (and / or LFA170A), 270, 370, 470, 570 and / or 670 described in detail above. Therefore, these parts and / or aspects will not be described in further detail herein.

[0222] The fluid transfer device 705 (also referred to herein as the "transfer device") may have any suitable shape, size, and / or configuration. In some embodiments, the transfer device 705 may be configured to draw bodily fluids (e.g., blood) from a patient and allow them to enter and / or pass through the transfer device 705. Additionally, the transfer device 705 may be configured to transfer at least some of the drawn bodily fluids to one or more other devices, reservoirs, containers, vials, machines, tests, assays, etc., such as the rapid diagnostic testing device 770 and / or one or more fluid collection devices (not included in the above description). Figure 8 and Figures 9A-9D (as shown in the image).

[0223] The transfer device 705 includes at least a housing 710 and an actuator 750. The housing 710 of the device 705 may have any suitable shape, size, and / or configuration. For example, in some embodiments, the housing 710 may be similar to and / or substantially the same as at least the housing 610 described above. Specifically, the housing 710 has and / or forms an inlet 712 and an outlet 713, and may define a fluid flow path 715 between them. The inlet 712 may be any suitable inlet or port and may be configured to establish fluid communication between the housing 710 and a source of bodily fluids (e.g., a patient). The outlet 713 may be any suitable outlet or port and may be configured to establish fluid communication between the housing 710 and a fluid collection device (not in...). Figure 8-9D (as shown in the image), such as any of those described in detail above. As further described herein, a fluid flow path 715, at least partially defined by the housing 710, extends between the inlet 712 and the outlet 713, and may selectively establish fluid communication therebetween.

[0224] As described above, at least reference is made to housing 610 and housing 710 ( Figure 8-9DThe enclosure (shown) includes, forms, and / or is coupled to an isolation chamber 730, which is configured to be selectively positioned in fluid communication with a fluid flow path and / or at least an inlet 712. Furthermore, the enclosure defines an opening 721 and / or a port configured to receive a portion of a rapid diagnostic test apparatus 770, as further described herein. The isolation chamber 730 may have any suitable shape, size, and / or configuration. For example, in some embodiments, the isolation chamber 730 and / or at least a portion thereof may be substantially similar in form and / or function to the isolation chambers 330, 430, and / or 630 described above. Therefore, no further detailed description of parts and / or aspects of the isolation chamber 730 is provided herein.

[0225] The actuator 750 of device 705 may have any suitable shape, size, and / or configuration. In some embodiments, the actuator 750 and / or aspects or portions thereof may be similar to and / or substantially identical to the actuators 150, 250, 350, 450, and / or 650 described in detail above. In some embodiments, the actuator 750 may be at least partially disposed within and / or partially formed by the housing 710. As described above, the actuator 750 may be configured to control, guide, and / or otherwise facilitate the selective flow of fluid through at least a portion of the housing 710 and / or at least a portion of one or more fluid flow paths. The actuator 750 may be any one or more suitable components or devices configured to switch between any number of states (e.g., two, three, four, or more) in any suitable manner (e.g., user actuation, automatic actuation, mechanical actuation, electronic actuation, chemical actuation, etc.).

[0226] More specifically, such as Figures 9A-9D As shown, actuator 750 includes a first member 751, a second member 760, and a third member 765. The first member 751 of actuator 750 may have any suitable shape, size, and / or configuration. For example, the first member 751 may be similar in form and / or function to the first member 651 of actuator 650 described in detail above. The first member 751 includes at least one seal 752 disposed at a first end of the first member 751. The arrangement of the seal 752 allows the seal 752 to engage and / or contact the inner surface of housing 710 to form and / or define a substantially fluid-impermeable seal therebetween.

[0227] The first end of the first member 751 also includes a port 725 in fluid communication with the sampling channel 735. In some embodiments, for example, the port 725 may be a valve, coupler, and / or any suitable reconfigurable component or device configured to (i) expel air or gas from the sampling channel 735 and / or allow air or gas to flow out of the sampling channel 735, and (ii) receive a portion of the rapid testing device 770 to place the rapid testing device 770 in fluid communication with the sampling channel 735, as described above with reference to port 625. The sampling channel 735 is disposed in and / or defined by the first member 751. For example, in some embodiments, the first member 751 may have a hollow elongated portion defining the sampling channel 735. Furthermore, this portion of the first member 751 may define and / or may have openings, ports, valves, selectively permeable components, etc., configured to place the sampling channel 735 in selective fluid communication with the isolation chamber 730. In some embodiments, although the sampling channel 735 is included in and / or defined by the first component 751 of the actuator 750, the sampling channel 735 may be at least in form and / or function similar to that referenced above. Figures 7A-7D The sampling portion 635 of the described isolation chamber 630 is similar.

[0228] like Figures 9A-9D As shown, the first member 751 also includes an engaging member 755 disposed at or on a second end of the first member 751 opposite to the first end. The engaging member 755 can be any suitable shape, size, and / or configuration. For example, in some embodiments, the engaging member 755 can be a protrusion, tab, button, knob, and / or any other suitable engaging member. As further described in detail herein, the engaging member 755 is configured to selectively engage a portion of the third member 765 of the actuator 750 to guide and / or at least partially control relative movement between the first member 751, the second member 760, and / or the third member 765.

[0229] The second component 760 of the actuator 750 can have any suitable shape, size, and / or configuration. For example... Figures 9A-9D As shown, a second member 760 may be disposed around and / or over at least a portion of the first member 751. The second member 760 includes a set of seals 761. As shown, the second member 760 may include a first end having an inner seal 761 and an outer seal 761, and a second end opposite the first end having an outer seal 761. In this way, the second member 760 may be similar to and / or substantially identical to the second member 660 of the actuator 650. Therefore, the second member 760 and / or aspects or portions thereof will not be described in detail herein.

[0230] The third component 765 may have any suitable shape, size, and / or configuration. In some embodiments, the third component 765 may be included in a portion of the housing 710 and / or the outer portion of the transmission device 705 and / or may form part of the housing 710 and / or the outer portion of the transmission device 705. For example, as Figures 9A-9D As shown, at least a portion of the housing 710, the first member 751, and the second member 760 may be disposed within a portion of the third member 765. More specifically, the third member 765 may be a substantially hollow cylinder, etc., having an open end and a substantially closed end. The substantially closed end includes a pawl, a recess, an opening, and / or an engagement structure (referred to herein as "engagement structure 766") and / or defines the pawl, recess, opening, and / or engagement structure. Engagement structure 766 may contact and / or otherwise selectively engage engagement member 755 of the first member 751. For example, as further described in detail herein, engagement member 755 may be configured to engage and / or contact engagement structure 766, which in turn may cause the first member 751 and the third member 765 to move together and / or simultaneously when the actuator 750 transitions between two or more states or configurations. Furthermore, as described in further detail herein, a portion of the switching of the actuator 750 can cause the engagement member 755 to disengage from and / or move relative to the engagement structure 766, which in turn can cause the first member 751 to move relative to the third member 765 (or vice versa).

[0231] like Figures 9A-9D As shown, the arrangement of the first component 751 and the second component 760 of the actuator such that the isolation chamber 730 is disposed and / or defined, for example, between a first end of the first component 751 and a first end of the second component 760. Additionally, the second component 760 is configured to at least partially define a fluid flow path 715 between the first end and the second end of the second component 760. Therefore, the first end of the second component 760 and the seal 761 (included in the first end) isolate and / or separate the isolation chamber 730 from the fluid flow path 715.

[0232] The actuator 750 is configured to transition between at least a first state, a second state, a third state, and a fourth state. For example... Figures 9A-9DAs shown, regardless of the state of the actuator 750, the first end of the first member 751 and the seal 752 included therein are disposed on and retained thereon on the first side of the inlet 712 and the first side of the outlet 713. Similarly, regardless of the state of the actuator 750, the second end of the second member 760 and the seal 761 included therein are disposed on and retained thereon on the second side of the inlet 712 (opposite to the first side) and the second side of the outlet 713 (opposite to the first side). However, the first end of the second member 760 and the seal 761 disposed therein are configured such that: (i) when the actuator 750 is in the first state ( Figure 9A ), second state ( Figure 9B ) and the third state ( Figure 9C (ii) When the actuator 750 is in the fourth state, it is set on the second side of the inlet 712 and the first side of the outlet 713, and (ii) when the actuator 750 is in the fourth state. Figure 9D The actuator 750 is positioned on the first side of the inlet 712 and the first side of the outlet 713. Therefore, as described in further detail herein, the arrangement of the actuator 750 allows the switching actuator 750 to selectively guide and / or switch the fluid flow between (i) the inlet 712 and the isolation chamber 730 and (ii) the inlet 712 and the outlet 713 via the fluid flow path 715.

[0233] The rapid diagnostic test apparatus 770 (also referred to herein as the "rapid test apparatus" or simply the "test apparatus") can be any suitable test apparatus. For example, as referenced above... Figure 2 As detailed in the LFA 170A shown, the rapid test apparatus 770 can be an LFA, etc. In some embodiments, the test apparatus 770 and / or aspects or portions thereof may be substantially similar to the rapid test apparatuses 170, 270, 370, 470, 570 and / or 670 described in detail above. Therefore, the rapid test apparatus 770 and / or aspects or portions thereof will not be described in detail herein.

[0234] like Figure 9DAs shown, the rapid testing device 770 includes a coupling member 778 coupled to and / or at least in fluid communication with the base 771 of the testing device 770 (e.g., directly coupled to the base 771 and / or coupled via an attachment mechanism such as attachment mechanism 579). When the rapid testing device 770 is connected to the transfer device 705, the coupling member 778 can be at least partially inserted through the opening 721 of the housing 710 to establish fluid communication with the sampling channel 735. For example, the coupling member 778 can be a puncture member, needle, tube, capillary, and / or the like capable of puncturing and / or otherwise advancing through the port 725. In some embodiments, the base 771 and the coupling member 778 can be substantially similar to the base 571 and / or 671 and the coupling member 578 and / or 678 described in detail above. Therefore, the base 771 and the coupling member 778 (and / or aspects or portions thereof) will not be described in detail here.

[0235] System 700 can be used to obtain one or more volumes of bodily fluid from a patient, which can be used for one or more testing, assay, and / or diagnostic procedures. As described above, for example, inlet 712 can be positioned in fluid communication with a source of bodily fluid. When inlet 712 is in fluid communication with a source of bodily fluid (e.g., a portion of a patient), actuator 750 can be in a first state, thereby establishing fluid communication between inlet 712 and isolation chamber 730 and isolating outlet 713 from inlet 712, as... Figure 9A As shown. Furthermore, when the actuator 750 is in the first state, the first end of the first member 751 may be close to or adjacent to the first side of the inlet 712, and the first end of the second member 760 may be close to or adjacent to the second side of the inlet 712. In this way, the isolation chamber 730 defined between the first member 751 and the second member 760 may have a first volume.

[0236] In some cases, once the inlet 712 is positioned in fluid communication with a bodily fluid source, the actuator 750 can transition from its first state to its second state. For example, as... Figure 9BAs shown, a user can apply a force to the third member 765, which is operable to move the third member 765 relative to the housing 710. As described above, the arrangement of the engaging member 755 of the first member 751 and the engaging structure 766 of the third member 765 such that movement of the third member 765 relative to the housing 710 results in a similar movement of the first member 751. The movement of the first member 751 is also relative to the second member 760 (e.g., the second member 760 has not yet moved), which in turn increases the volume of the isolation chamber 730 disposed between the first member 751 and the second member 760. Furthermore, the conversion and / or movement of the first member 751 can reduce the volume within the housing 710 on the side of the first member 751 opposite to the isolation chamber 730, and the opening 721 allows air or gas contained therein to escape and / or flow out of the sampling channel 735. Thus, the actuator 750 moves from its first state ( Figure 9A ) transforms into its second state ( Figure 9B This can result in a negative pressure differential in the isolation chamber, allowing for the operative extraction of an initial volume of bodily fluid from a source through inlet 712 and into isolation chamber 730, as described above with reference to isolation chamber 630. Furthermore, the initial volume of bodily fluid can be any suitable volume, such as any of the volumes or amounts described above.

[0237] When the initial volume of bodily fluid is contained in the isolation chamber 730, the actuator 750 can be activated from its second state ( Figure 9B ) transition to its third state ( Figure 9C As described above with reference to transmission device 605, the transition of actuator 750 from the second state to the third state may be in response to an initial volume of bodily fluid in isolation chamber 730, in response to the equalization of one or more pressure differentials, in response to a given point in the continuous process of actuator 750 transitioning from the first state to the fourth state, etc. In some cases, the transition may be automatic or in response to an applied force.

[0238] like Figure 9C As shown, switching actuator 750 to the third state may include switching and / or moving the first member 751 and the third member 765 relative to housing 710 and the second member 760 by additional amounts. More specifically, when in the third state, the first member 751 may be positioned relative to the second member 760 such that openings, ports, valves, etc. (here referred to as "opening 754") are positioned in fluid communication with isolation chamber 730 and / or inlet 712, such as... Figure 9C As shown. In this way, a certain volume of bodily fluid can be transferred into the sampling channel 735 defined by the first member 751. As described above, in some embodiments, the port 725 can be configured to vent the sampling channel 735 to facilitate the inflow of bodily fluid into the sampling channel 735.

[0239] With a certain volume of body fluid contained in the sampling channel 735, the actuator 750 can transition from its third state ( Figure 9C ) transition to its fourth state ( Figure 9D More specifically, in some embodiments, the third member 765 and the second member 760 may move relative to the housing 710, while the first member 751 remains in a substantially fixed position relative to the housing 710. In other words, the third member 765 and the second member 760 move together and relative to the first member 751.

[0240] like Figure 9D As shown, when actuator 750 transitions to the fourth state, engagement member 755 disengages from engagement surface 766 and / or moves relative to engagement surface 766. In some embodiments, engagement member 755 and / or engagement surface 766 may be sized and / or configured to maintain contact and / or engagement until a desired and / or predetermined force sufficient to overcome the forces maintaining engagement (e.g., friction, forces sufficient to elastically and / or plastically deform engagement member 755 and / or engagement surface 766, and / or any other suitable force) is applied. In other words, the third member 765 may move relative to the first member 751 when the force meets a criterion and / or exceeds a threshold amount.

[0241] When actuator 750 transitions to the fourth state, the second component 760 of actuator 750 moves together with the third component 765 in the same direction. Figure 9D As shown, the transfer and / or movement of the second component 760 moves the first end of the second component 760 from the second side of the inlet 712 and / or to the first side of the inlet 712, thereby isolating and / or fluid-isolating the isolation chamber 730 from the inlet 712. Furthermore, the transfer and / or movement of the second component 760 relative to the first component 751 can place the opening 754 of the first component 751 on the opposite side of the internal seal 561 included in or on the first end of the second component 760, which in some cases may allow venting of the sampling passage 735, as described in further detail herein.

[0242] like Figure 9DAs shown, the rapid testing device 770 can be coupled to the housing 710 and / or can be at least partially inserted into and / or through the opening 721 of the housing 710 to allow the coupling member 778 to establish fluid communication with the sampling channel 735 (e.g., through port 725). Thus, at least a portion of bodily fluid can be transferred from the sampling channel 735 into the rapid testing device 770, as described above in detail with reference to rapid testing devices 470, 570, and / or 670. In some embodiments, transferring a volume of bodily fluid from the sampling channel 735 into the rapid testing device 770 can initiate testing and / or determination of that initial volume of bodily fluid, as described above in detail with reference to rapid testing device 270. Furthermore, in some cases, venting the sampling channel 735 via the opening 754 can allow a desired pressure differential within the sampling channel 735, which can facilitate the transfer of bodily fluid from the sampling channel 735 into the rapid testing device 770. The rapid testing device 770 can be configured to perform any suitable test and / or determination (e.g., testing for the presence of lactic acid and / or PCT), such as any of those described in detail above. Furthermore, once the test or determination is complete, the rapid testing device 770 can be configured to output test results that can be detected and / or evaluated by a person and / or one or more electronic devices, as described in detail above with reference to rapid testing devices 170, 270, 370, 470, 570, and / or 670.

[0243] As described above, switching actuator 750 from its third state to its fourth state can isolate, separate, isolate, and / or retain the initial volume of bodily fluids within the isolation chamber 730 and / or the rapid testing device 770, which in turn isolates contaminants from the initial volume. Furthermore, as described in detail above, the arrangement of the rapid testing device 770 makes the tests and / or measurements performed by the rapid testing device 770 less susceptible to such contamination, meaning that the accuracy of the test results output by the rapid testing device 770 is unaffected by such contamination.

[0244] like Figure 9D As shown, transitioning actuator 750 from its third state to its fourth state establishes fluid communication between inlet 712 and outlet 713 via a fluid flow path 715 disposed between the first and second ends of the second member 760 of actuator 750. When actuator 750 is in its fourth state, the first end of the second member 760 is disposed on the first side of inlet 712, and the second end of the second member 760 is disposed on the second side of outlet 713, as described above in detail with reference to actuator 650.

[0245] In some embodiments, before or after the actuator 750 is placed in its fourth state, the outlet 713 may be positioned in fluid communication with the fluid collection device. Figure 8-9D(Not shown in the text). As described in detail above, the fluid collection device may define negative pressure and / or suction and / or be configured to generate negative pressure and / or suction, which can be used to draw bodily fluids into the fluid collection device. Therefore, in response to negative pressure and / or suction, one or more subsequent volumes of bodily fluid may flow from inlet 712, through fluid flow path 715, through outlet 713, and into the fluid collection device. As described above, isolating the initial volume of bodily fluid in isolation chamber 730 before collecting or acquiring one or more subsequent volumes reduces and / or substantially eliminates the amount of contaminants in one or more subsequent volumes. Therefore, system 700 may be configured to acquire an initial volume of bodily fluid and subsequent volumes of bodily fluid, the initial volume of bodily fluid being used for rapid testing with relatively low sensitivity to contamination, and subsequent volumes of bodily fluid being used for testing with relatively high sensitivity to contamination, as described above with reference to systems 100, 200, 300, 400, and / or 600.

[0246] Figure 10 , Figure 11 and Figure 12A-12D A fluid transfer and measurement system 800 according to an embodiment is shown. The fluid transfer and measurement system 800 (also referred to herein as the “system”) may include at least a fluid transfer device 805 and a rapid diagnostic testing device 870. Parts and / or aspects of the fluid transfer device 805 and / or the rapid diagnostic testing device 870 may be similar to and / or substantially identical to the fluid transfer devices 105, 205, 305, 405, 505, 605 and / or 705 and / or the rapid diagnostic testing devices 170 (and / or LFA 170A), 270, 370, 470, 570, 670 and / or 770 described in detail above. Therefore, these parts and / or aspects will not be described in further detail herein.

[0247] The fluid transfer device 805 (also referred to herein as the "transfer device") may have any suitable shape, size, and / or configuration. In some embodiments, the transfer device 805 may be configured to draw bodily fluids (e.g., blood) from a patient and allow them to enter and / or pass through the transfer device 805. Additionally, the transfer device 805 may be configured to transfer at least some of the drawn bodily fluids to one or more other devices, reservoirs, containers, vials, machines, tests, assays, etc., such as the rapid diagnostic testing device 870 and / or one or more fluid collection devices (not included in the above description). Figure 10 , Figure 11 and Figure 12A-12D (as shown in the image).

[0248] The delivery device 805 includes at least a housing 810 and an actuator 850. The housing 810 of the device 805 may have any suitable shape, size, and / or configuration. For example, in some embodiments, the housing 810 may be similar to and / or substantially identical to any of the housings 210, 310, 410, 510, 610, and / or 710 described above. Specifically, the housing 810 has and / or forms an inlet 812 and an outlet 813. The housing 810 may form and / or define an actuator chamber 814, a fluid flow path 815, and an isolation chamber 830. The inlet 812 may be any suitable inlet or port and may be configured to establish fluid communication between the housing 810 and a source of bodily fluids (e.g., a patient). Figure 11 As shown, inlet 812 is in fluid communication with actuator chamber 814, which in turn is in fluid communication with fluid flow path 815 and isolation chamber 830. Outlet 813 can be any suitable outlet or port and can be configured to establish fluid communication between housing 810 and fluid collection device (not shown in the diagram). Figures 10-12D (as shown in the image), such as any of those described in detail above. Outlet 813 is in fluid communication with fluid flow path 815. Furthermore, outlet 813 is configured to be in selective fluid communication with isolation chamber 830 via flow controller 840, as described in further detail herein.

[0249] Isolation chamber 830 may be configured to receive a flow and / or volume of bodily fluids from inlet 812 and to isolate (e.g., isolate, separate, contain, retain, segregate, etc.) at least a portion of the flow and / or volume of bodily fluids within isolation chamber 830, as further described herein. Isolation chamber 830 may have any suitable shape, size, and / or configuration. For example, in some embodiments, isolation chamber 830 and / or at least a portion thereof may be substantially similar in form and / or function to isolation chambers 330, 430, 630, and / or 730 described above. Therefore, parts and / or aspects of isolation chamber 830 will not be described in further detail herein.

[0250] A flow controller 840 is at least partially disposed within the housing 810 and configured to control, guide, and / or otherwise facilitate the selective passage of fluid through at least a portion of the housing 810, at least a portion of the fluid flow path 815, and / or at least a portion of the isolation chamber 830. The flow controller 840 may be configured to facilitate the movement of fluid through one or more portions of the housing 810, which in some cases may allow or result in pressure differentials and / or pressure equalization across one or more portions of the housing 810. In this document, the fluid flow may be, for example, a liquid such as water, oil, wetting fluid, bodily fluid, and / or any other suitable liquid, and / or a gas such as air, oxygen, carbon dioxide, helium, nitrogen, ethylene oxide, and / or any other suitable gas.

[0251] The flow controller 840 can have any suitable shape, size, and / or configuration. In some embodiments, the flow controller 840 can be compared with the above-referenced... Figure 4 The flow controller 340 described in detail is similar to and / or substantially the same. For example, the flow controller 840 can be configured to transition from a first state to a second state in response to pressure differential, suction, contact with body fluids, and / or flow of body fluids. More specifically, as shown in the figure... Figures 10-12D In the illustrated embodiment, the flow controller 840 may be a component or device formed of an absorbent or semi-permeable material, configured to be permeable to a gas or air flow but impermeable to a liquid (e.g., blood or other bodily fluid) flow when in a first state, and configured to be impermeable to both gas and liquid when in a second state. Therefore, the flow controller 840 and / or aspects or portions thereof will not be described in detail herein.

[0252] The actuator 850 of device 805 may have any suitable shape, size, and / or configuration. For example, actuator 850 may be any suitable one or more components or devices configured to switch between any number of states (e.g., two, three, four, or more) in any suitable manner (e.g., user actuation, automatic actuation, mechanical actuation, electronic actuation, chemical actuation, etc.). In some embodiments, actuator 850 and / or aspects or portions thereof may be similar to and / or substantially identical to the actuators 150, 250, 350, 450, 650, and / or 750 described in detail above. Figure 11 As shown, actuator 850 forms and / or includes a rod that is at least partially movably disposed within a portion of actuator chamber 814 of housing 810. Additionally, actuator 850 includes a set of seals 852 disposed at predetermined locations along the length of actuator 850 (or rod), which may allow actuator 850 to control, guide, and / or otherwise facilitate selective flow of fluid through at least a portion of housing 810. As further described in detail herein, actuator 850 includes a set of four seals 852 disposed at desired locations along the length of actuator 850 (or rod) to selectively control fluid flow from inlet 812 into at least one of isolation chamber 830, rapid diagnostic test device 870, and / or fluid flow path 815. Furthermore, the arrangement of seals 852 may also allow actuator 850 to isolate isolation chamber 830, rapid diagnostic test device 870, and / or fluid flow path 815 when actuator 850 switches between two or more states.

[0253] Although the rapid testing device included in the foregoing embodiments has been shown and / or described as being coupled to housing 810, in Figures 10-12DIn the illustrated embodiment, the rapid test device 870 is disposed within and / or integrated into the housing 810. The rapid diagnostic test device 870 (also referred to herein as a “rapid test device” or simply a “test device”) can be any suitable test device. For example, the rapid test device 870 and / or aspects or portions thereof can be substantially similar to the rapid test devices 170, 270, 370, 470, 570, 670, and / or 770 described in detail above. In some embodiments, as referenced above… Figure 2 The rapid testing device 870 described in detail in the LFA 170A shown can be an LFA, etc.

[0254] For example, such as Figure 11 As shown, the rapid testing device 870 includes at least a sampling element 872 disposed at one end of a substrate 871, a coupling element 873 disposed on the substrate 871 downstream of the sampling element 872, a capture element 874 disposed on the substrate 871 downstream of the coupling element 873, and a control element 875 disposed on the substrate 871 downstream of the capture element 874. The rapid testing device 870 may be disposed within a housing 810 such that the capture element 874 and the control element 875 can be observed from the outside of the housing 810 through an observation opening 819, etc. Furthermore, the housing 810 and / or the rapid testing device 870 includes and / or is coupled to a buffer actuator 880 containing a volume of buffer solution 881. In some embodiments, the buffer actuator 880 may be a blister pack, a fragile or puncture-resistant container, a reservoir including one or more reconfigurable components (e.g., one or more valves or flow controllers), etc. As further described in detail herein, the buffer actuator 880 can be actuated to provide a buffer solution 881 to the sampling element 872 of the rapid testing device 870, which in turn can be mixed with the volume of bodily fluid transferred to the sampling element 872.

[0255] System 800 can be used to obtain one or more volumes of bodily fluid from a patient, which can be used for one or more testing, assay, and / or diagnostic procedures. As described above, for example, inlet 812 can be positioned in fluid communication with a source of bodily fluid. When inlet 812 is positioned in fluid communication with a source of bodily fluid (e.g., a portion of the patient), actuator 850 can be in a first state, thereby establishing fluid communication between inlet 812 and isolation chamber 830, such as... Figure 11As shown. More specifically, when the actuator 850 is in the first state, the inlet 812 and the isolation chamber 830 can be in fluid communication with a portion of the actuator chamber 814 defined between the two seals 852 of the actuator 850. For example, a first seal 852 (e.g., an end seal) located at or near the end of the actuator 850 can be positioned within the actuator chamber 814 between the rapid test device 870 and the isolation chamber 830, and a second seal 852 adjacent to (or closest to) the first or end seal 852 can be positioned within the actuator chamber 814 between the inlet 812 and the fluid flow path 815. In this way, when the actuator 850 is in the first state, the inlet 812 is in fluid communication with the isolation chamber 830, as... Figure 11 As shown.

[0256] exist Figures 10-12D In the illustrated embodiments, once inlet 812 is positioned in fluid communication with a source of bodily fluid (e.g., a portion of a patient's body fluid), outlet 813 can be fluidly coupled to a fluid collection device, such as any of those described herein. For example, the fluid collection device can be any suitable reservoir, container, and / or device configured to receive a volume of bodily fluid. In some embodiments, the fluid collection device can be a vacuum reservoir or container defining a negative pressure, and / or can be a syringe that can be manipulated to generate a negative pressure. Thus, coupling the fluid collection device to outlet 813 selectively exposes at least a portion of the fluid flow path 815 to the negative pressure and / or suction within the fluid collection device.

[0257] Actuator 850 is configured to be in a first state when the fluid collection device is fluidly coupled to outlet 813. For example... Figure 12A As shown, the fluid flow path 815 is in fluid communication with a portion of the actuator chamber 814, which is defined between a seal 852 (e.g., the second from the bottom) disposed between the inlet 812 and the fluid flow path 815, and an adjacent seal 852 (e.g., the third from the bottom) disposed on the opposite side of the fluid flow path 815. In this way, the fluid flow path 815 positions the outlet 813 in fluid communication with a portion of the actuator chamber 814, which is isolated and / or fluid-separated by seals 852 disposed on either side of the fluid flow path 815. As described above, the outlet 813 and / or the fluid flow path 815 are also in fluid communication with the flow controller 840, which can be in its first state when the fluid collection device is coupled to the outlet 813.

[0258] The arrangement of the flow controller 840 (e.g., a selectively permeable component) allows air or gas flow to pass through the flow controller 840 between the outlet 813 (and / or fluid flow path 815) and the isolation chamber 830, while liquid flow (e.g., bodily fluid) is not allowed to pass through the flow controller 840. As a result, at least a portion of the negative pressure differential or suction generated by the fluid collection device can be transferred into and / or through the isolation chamber 830, which can then be used to aspirate an initial volume of bodily fluid from a bodily fluid source, through the inlet 812, a portion of the actuator chamber 814 defined between two respective seals 852, and into the isolation chamber 830, as described above in detail with reference to the transfer device 305.

[0259] The initial volume of the bodily fluid can be any suitable volume, such as any of the volumes or amounts described above. For example, in some cases, actuator 850 and / or delivery device 805 may remain in a first state or configuration until a predetermined and / or desired volume (e.g., the initial volume) of bodily fluid is delivered to isolation chamber 830. In some embodiments, the initial volume may be associated with and / or at least partially based on the volume of isolation chamber 830 or a portion thereof (e.g., a volume sufficient to fill isolation chamber 830 or a desired portion of isolation chamber 830). In some embodiments, delivery device 805 may be configured to deliver a flow of bodily fluid (e.g., the initial volume) into isolation chamber 830 until flow controller 840 transitions to its second configuration. In other words, in some embodiments, delivering the initial volume of bodily fluid into isolation chamber 830 may be used to place flow controller 840 in its second state or configuration. For example, transferring an initial volume of body fluid into isolation chamber 830 may cause at least a portion of the initial volume to wet and / or saturate flow controller 840, which in turn places flow controller 840 in its second state, as described above in detail with reference to flow controller 340. Figure 12A and Figure 12B As shown, the initial volume of the body fluid is sufficient to substantially fill the isolation chamber 830, such that at least a portion of the initial volume is disposed within the actuator chamber 814 between the two seals 852 (e.g., the two lowest seals 852).

[0260] When the flow controller 840 switches to its second state and / or configuration, it isolates and / or separates the isolation chamber 830 from the outlet 813. This prevents the negative pressure and / or suction generated by the fluid collection device from acting on or passing through the isolation chamber 830. In some cases, this allows the pressure differential between the isolation chamber 830 and the inlet 812 to be substantially equal and / or reduced below a desired threshold. In some cases, pressure equalization can stop the inflow of bodily fluids into the isolation chamber 830.

[0261] After the initial volume of bodily fluid is contained in the isolation chamber 830, the actuator 850 can be released from its first state ( Figure 11 and Figure 12A ) transforms into its second state ( Figure 12B and Figure 12C This transitions the transmission device 805 from its first state to its second state. As described above with reference to transmission device 605, the transition of actuator 850 from the first state to the second state may be responsive to an initial volume of bodily fluid placed in isolation chamber 830, responsive to equalization of one or more pressure differentials, etc. In some cases, the transition may be automatic or responsive to an applied force (e.g., as...). Figure 12B (As indicated by the middle arrow).

[0262] like Figure 12B As shown, when in the second state or configuration, the actuator 850 can be disposed within the actuator chamber 814 such that the seal 852 is positioned relative to the rapid test device 870, the isolation chamber 830, the inlet 812, and the fluid flow path 815. For example, the isolation chamber 830 is in fluid communication with a portion of the actuator chamber 814, said portion being disposed between the seal 852 (located between the rapid test device 870 and the isolation chamber 830) and the seal 852 (located between the isolation chamber 830 and the inlet 812). Thus, when the flow controller 840 is in its second state and the actuator 850 switches to its second state, the isolation chamber 830 is isolated and / or fluidly separated from other parts of the transfer device 805 (see, for example...). Figures 12B-12D In other words, actuator 850 (and flow controller 840) can isolate and / or separate isolation chamber 830 from inlet 812, outlet 813, fluid flow path 815, and rapid testing device 870. In some cases, isolating the initial volume of bodily fluid in isolation chamber 830 can also isolate contaminants in the initial volume.

[0263] like Figure 12CAs shown, when in the second state or configuration, actuator 850 also establishes fluid communication between inlet 812 and outlet 813 via fluid flow path 815 and a portion of actuator chamber 814. For example, in some embodiments, inlet 812 and fluid flow path 815 are each in fluid communication with a portion of actuator chamber 814 disposed between a respective pair of seals 852 (e.g., a top pair of seals 852). Thus, in response to negative pressure and / or suction generated by the fluid collection device, one or more subsequent volumes of body fluid may flow from inlet 812, through a portion of actuator chamber 814 and fluid flow path 815, through outlet 813, and into the fluid collection device (not shown). As described above, isolating the initial volume of body fluid in isolation chamber 830 before collecting or obtaining one or more subsequent volumes of body fluid reduces and / or substantially eliminates the amount of contaminants in one or more subsequent volumes.

[0264] like Figure 12C As shown, when the actuator 850 is in the second state or configuration, the rapid testing device 870 is in partial fluid communication with the actuator chamber 814 disposed between a corresponding pair of seals 852 (e.g., end pairs). This allows a portion of the initial volume of bodily fluid disposed within the actuator chamber 814 between the pair of seals 852 to be transferred to or over the sampling element 872 of the rapid testing device 870. Figure 12D As shown, by manipulating and / or engaging the buffer actuator 880 to transition the buffer actuator 880 from its first state to its second state, the transmission device 805 can be transitioned from its second state to a third state to transmit at least a portion of the buffer solution 881 contained therein to or onto the sampling element 872. For example, the buffer actuator 880 may include a fragile portion that can break and / or puncture in response to a force applied by a user to the buffer actuator 880. Figure 12D As shown, the rapid testing device 870 and / or housing 810 may include a puncture member 882, etc., which may be configured to rupture, puncture, and / or otherwise open the buffer solution. In such embodiments, the puncture member 882 may define a lumen capable of fluid communication with the sampling element 872. Thus, the force applied to the buffer actuator 880 may be used to transfer at least a portion of the buffer solution 881 into and / or onto the sampling element 872. Furthermore, as a large amount of bodily fluid is also transferred to the sampling element 872, the bodily fluid and the buffer solution 881 may begin to mix.

[0265] In some embodiments, the mixing of body fluid with buffer solution 881 in or above sampling element 872 can initiate testing and / or determination of body fluid, as described above in detail with reference to rapid testing device 270. Furthermore, rapid testing device 870 can be configured to perform any suitable test and / or determination. In some embodiments, buffer solution 881 can be at least partially based on the ongoing test. For example, in some cases, as described above, rapid testing device 870 can be configured to test for the presence of lactate and / or PCT. Furthermore, once the test or determination is complete, rapid testing device 870 can be configured to output test results that can be detected and / or evaluated. For example, in some cases, a person can observe capture element 874 and / or control element 875 through observation opening 819 defined by housing 810. In other embodiments, the electronic device can perform one or more scans of capture element 874 and / or control element 875 via observation opening 819. In other embodiments, one or more electronic devices may be integrated and / or disposed in housing 810, and the capturing element 874 and / or control element 875 do not need to be observed by a person.

[0266] As described in detail above, in some embodiments, the arrangement of the rapid testing device 870 can make the tests and / or measurements performed by the rapid testing device 870 less susceptible to such contamination. This means that the accuracy of the test results output by the rapid testing device 870 is not affected by contamination that may be contained in the initial volume of body fluid, as described in detail above. Therefore, the system 800 can be configured to acquire an initial volume of body fluid and one or more subsequent volumes of body fluid, the initial volume of body fluid being usable for rapid tests with relatively low sensitivity to contamination, and the subsequent volumes of body fluid being usable for tests with relatively high sensitivity to contamination, as described above with reference to systems 100, 200, 300, 400, 600, and / or 700.

[0267] Figures 13 to 16 A fluid transfer and measurement system 900 according to at least a portion of an embodiment is shown. The fluid transfer and measurement system 900 (also referred to herein as the “system”) may include at least a fluid transfer device 905 and a rapid diagnostic testing device 970. Parts and / or aspects of the system 900 may be similar to and / or substantially identical to the systems (or devices) 100, 200, 300, 400, 500, 600, 700, and / or 800 described in detail above. Therefore, these parts and / or aspects will not be described in further detail herein.

[0268] The fluid delivery device 905 (also referred to herein as the "delivery device") may have any suitable shape, size, and / or configuration. In some embodiments, the delivery device 905 may be configured to draw bodily fluids (e.g., blood) from a patient and deliver them into and / or through the delivery device 905. Additionally, the delivery device 905 may be configured to deliver at least some of the drawn bodily fluids to one or more other devices, reservoirs, containers, vials, machines, tests, assays, etc., such as the rapid diagnostic testing device 970 and / or one or more fluid collection devices (not included in the above description). Figure 13-16 (as shown in the image). In some embodiments, the transmission device 905 and / or aspects or portions thereof may be substantially similar to any of the transmission devices 105, 205, 305, 405, 505, 605, 705 and / or 805 described in detail above.

[0269] For example, the transfer device 905 includes at least a housing 910 and an actuator 950. The housing 910 has and / or forms an inlet 912 and an outlet 913. The inlet 912 can be any suitable inlet or port and can be configured to establish fluid communication between the housing 910 and a source of bodily fluid (e.g., a patient). The outlet 913 can be any suitable outlet or port and can be configured to establish fluid communication between the housing 910 and a fluid collection device (not in...). Figures 13-16 (as shown in the image), such as any of those described in detail above. Additionally, housing 910 includes and / or defines a port 925, which can be configured to establish fluid communication between at least a portion of housing 910 and / or one or more reservoirs or chambers disposed therein and, for example, a rapid diagnostic test device 970. In some embodiments, port 925 may be at least in form and / or function similar to those described above. Figures 6A-6D The port 525 described is substantially similar. In this way, housing 910 and / or parts or aspects thereof may be similar to and / or substantially identical to any of the aforementioned housings 210, 310, 410, 510, 610, 710 and / or 810, and therefore will not be described in detail herein.

[0270] Actuator 950 is at least partially disposed within housing 910. Actuator 950 of device 905 may have any suitable shape, size, and / or configuration. For example, actuator 950 may be a component or device configured to switch between two or more states to control, guide, and / or otherwise facilitate selective flow of fluid through at least a portion of housing 910. Furthermore, actuator 950 may be actuated and / or switched between any number of states in any suitable manner. Figures 13-16In the illustrated embodiments, actuator 950 can switch between at least a first state and a second state. When in the first state, actuator 950 can be configured to allow an initial volume of bodily fluid to enter from inlet 912 into the initial or first portion of housing 910, such as the isolation chambers described in detail above with reference to isolation chambers 330, 430, 630, 730, and / or 830. In some embodiments, when in the first state, actuator 950 can be configured to isolate, separate, divide, and / or otherwise prevent fluid communication between outlet 913 and inlet 912, and / or between outlet 913 and the initial or first portion of housing 910. When in the second state, actuator 950 can be configured to allow a subsequent volume of bodily fluid (e.g., a volume of bodily fluid following the initial volume) to be transferred from inlet 912 through at least a portion (e.g., the second portion) of housing 910 to outlet 913 (and / or a fluid collection device fluidly coupled to outlet 913). Furthermore, when in the second state, actuator 950 can be configured to isolate, separate, disconnect, and / or otherwise prevent fluid communication between the initial or first portion of housing 910 and inlet 912, outlet 913, and / or one or more other portions of housing 910. In this way, actuator 950 and / or portions or aspects thereof can be substantially similar to any of the actuators 250, 350, 450, 650, 750, and / or 850 described in detail above, and therefore will not be described in detail herein.

[0271] The rapid diagnostic test apparatus 970 (also referred to herein as the “rapid test apparatus” or simply the “test apparatus”) can be any suitable test apparatus. For example, the test apparatus 970 and / or aspects or portions thereof can be substantially similar to the rapid test apparatuses 170, 270, 370, 470, 570, 670, 770 and / or 870 described in detail above. In some embodiments, the rapid test apparatus 970 can be an LFA, etc., as referenced above. Figure 2 As detailed in the LFA 170A shown. For example, the rapid testing apparatus 970 includes at least a sampling element 972 located at one end of a substrate 971, a coupling element 973 located on the substrate 971 downstream of the sampling element 972, a capture element 974 located on the substrate 971 downstream of the coupling element 973, and a control element 975 located on the substrate 971 downstream of the capture element 974.

[0272] The rapid testing device 970 also includes a housing 983 and a testing device actuator 986, the housing 983 being configured to contain and / or accommodate at least a portion of the rapid testing device 970, and the testing device actuator 986 being configured to selectively establish fluid communication between the rapid testing device 970 and the housing 910. In some embodiments, the rapid testing device 970 may be configured as a substantially modular device that can be coupled to and / or attached to any suitable fluid transfer device, conduit, reservoir, mechanism, transfer adapter, etc. In some embodiments, the modular arrangement of the testing device 970 may allow the transfer device 905 and the testing device 970 to be manufactured and / or transported independently, and coupled and / or assembled at the point of use. In some embodiments, the modular arrangement of the testing device 970 may allow various forms of the testing device 970 to be compatible with the transfer device 905, wherein each form of the testing device 970 is configured to perform different tests or determinations. In other words, the modular arrangement of the testing device 970 may allow different forms of the testing device 970 to test different biomarkers while maintaining substantially the same form factor and / or compatibility.

[0273] like Figures 14-16 As shown, housing 983 can have any suitable shape, size, and / or configuration. In some embodiments, housing 983 of test device 970 may be configured to be coupled to a portion of housing 910 of transfer device 905. Housing 983 includes, receives, and / or defines an exhaust port 985, configured to allow air or gas to flow out of housing 983. As described in detail above with reference to the transfer device, in some embodiments, venting housing 983 of test device 970 may facilitate fluid flow through test device 970 (e.g., along substrate 971). Additionally, housing 983 includes and / or defines an observation opening 984. Figure 14 and Figure 15 As shown, the test device 970 may be disposed within the housing 983 such that at least the capture element 974 and / or the control element 975 are visible and / or detectable through the observation opening 984.

[0274] The test device actuator 986 is movably coupled to the housing 983 of the test device 970 and configured to transition between a first state and a second state to establish fluid communication between the transmission device 905 and the test device 905. For example, in some embodiments, the test device actuator 986 may be a spring-loaded button, etc., which may include a puncture member 987. The test device 970 and / or the housing 983 of the test device 970 may include a diaphragm 988 and / or may form a diaphragm 988. Additionally, the test device actuator 986 may be aligned with the diaphragm 988. In some embodiments, the test device actuator 986 may be configured such that when the test device actuator 986 is in the first state, the puncture member 987 is disposed on a first side of the diaphragm 988 and within the housing 983 of the measuring device 970 (see, for example, Figure 15 ), and when the test device actuator 986 is in the second state, the puncture member 987 extends through the diaphragm 988 and is outside the housing 983 of the test device 970 (not in Figures 13-16 (as shown in the image).

[0275] The test device 970 and / or its housing 983 are configured to be coupled to the housing 910 of the transmission device 905 such that the test device actuator 986 is substantially aligned with the port 925 included in and / or formed by the housing 910. Thus, when the test device actuator 986 transitions to its second state, the puncture member 987 can extend through the diaphragm 988 of the test device 970 and through the port 925 of the transmission device 905 to establish fluid communication therebetween. In this way, the puncture member 987 can receive at least a portion of the initial volume of bodily fluid disposed in the transmission device 905 (e.g., via capillary action, pressure differential, and / or any other form of fluid transfer). Figure 15 As shown, the puncture member 987 is in fluid communication with a portion of the base 971, such as the sampling element 972. Therefore, body fluid can be transferred from a portion of the transfer device 905 (e.g., a portion of the housing, an isolation chamber, etc.) to the sampling element 972.

[0276] although Figures 13-16Not shown, but in some embodiments, the testing device 970 may be configured to deliver a buffer solution, along with the volume of bodily fluid, to the sampling element 972 (e.g., as described above with reference to testing device 870). In such embodiments, the buffer solution may be mixed with the volume of bodily fluid, and the mixture may flow along the substrate 971 for testing, as detailed above. In some embodiments, the rapid testing device 970 may be configured to test for the presence of lactate and / or PCT, the presence of which may indicate a patient condition such as sepsis. Furthermore, once the test or assay is complete, the rapid testing device 970 may be configured to output test results that can be detected and / or evaluated. For example, in some cases, a person may observe the capture element 974 and / or control element 975 through an observation opening 984 defined by the housing 983 of the testing device 970. In other embodiments, the electronic device may perform one or more scans of the capture element 974 and / or control element 975 via the observation opening 984. In other embodiments, one or more electronic devices may be integrated and / or disposed within housing 910, and the capturing element 974 and / or control element 975 do not require human observation.

[0277] In addition to delivering a certain volume of body fluid to the rapid testing device 970, in some cases, the transfer device 905 may also be configured to transfer one or more subsequent volumes of body fluid to any suitable device, reservoir, testing device, etc., coupled to the outlet 913. Thus, the system 900 may be configured to acquire an initial volume of body fluid suitable for rapid testing (e.g., a test with relatively low sensitivity to contamination) and one or more subsequent volumes of body fluid suitable for subsequent testing (e.g., a test with relatively high sensitivity to contamination), as described above with reference to systems 100, 200, 300, 400, 600, 700, and / or 800.

[0278] Figures 17-20 Various examples of fluid transfer and measurement systems and / or devices according to different implementation schemes are shown. For example, Figure 17 A fluid transfer and measurement system 1000 (also referred to herein as the "system") is shown. System 1000 may be similar in form and / or function to the above-referenced system. Figures 13-16 The described system 900 is essentially similar. Although the port 925 of the transmission device 905 is... Figure 14 It is shown to be located at or near the end of the housing 910, but Figure 17 In the illustrated embodiment, the transmission device included in system 1000 may include and / or form a port disposed near or adjacent to its inlet. In this way, the flow of bodily fluids through a rapid testing device coupled to the transmission device of system 1000 can be relative to, for example, the flow described above. Figures 13-17The fluid flow in the described rapid testing device 970 is in essentially opposite directions.

[0279] Figure 18 A fluid transfer and measurement system 1100 (also referred to herein as the "system") is illustrated. In this embodiment, system 1100 includes an "in-line" rapid diagnostic testing device. For example, in some embodiments, system 1100 may include an in-line rapid diagnostic testing device included in and / or coupled to an inlet conduit, an outlet conduit, and / or any other suitable portion of system 1100. In some embodiments, the in-line rapid testing device included in the system may receive a flow of bodily fluid and may perform tests or measurements as described in detail above. Furthermore, in some cases, the in-line rapid testing device may include one or more flow-through or bypass mechanisms (e.g., automatic or manual actuation mechanisms) that may allow bodily fluid to flow through the in-line rapid testing device after receiving an initial volume of bodily fluid. Thus, the in-line rapid testing device may perform one or more tests or measurements on an initial volume of bodily fluid while subsequent volumes of bodily fluid continue to flow through system 1100.

[0280] Figure 19 A fluid transfer and measurement system 1200 (also referred to herein as the "system") is shown. In this embodiment, the system 1200 includes a fluid transfer device configured as a syringe. In some embodiments, the syringe may be, for example, a standard syringe configured to draw a volume of bodily fluid. In other embodiments, the syringe may be, for example, a syringe configured to draw and isolate an initial volume of bodily fluid prior to drawing a "sample volume". For example, such a syringe may be similar to and / or substantially identical to any of those described above in the '495 patent and / or '006 publication, which are incorporated herein by reference. Figure 19 As shown, system 1200 may include a rapid diagnostic testing device that can be coupled to any suitable portion of a syringe for placement in fluid communication with its internal volume. In embodiments where the syringe is configured to aspirate and isolate an initial volume of bodily fluid, the rapid testing device can be coupled to the syringe such that fluid communication is established between the isolating portion of the syringe and the rapid testing device. In this way, system 1200 may be at least similar to systems 300, 400, 600, 700 and / or 800 described in detail above.

[0281] Figure 20A fluid transfer and measurement system 1300 (also referred to herein as the “system”) is shown. In this embodiment, system 1300 includes a fluid transfer device fluidly coupled to, for example, a syringe. As described above with reference to at least systems 200, 300, and 800, system 1300 may include a fluid transfer device configured to draw an initial volume of bodily fluid into an isolation chamber and configured to draw subsequent volumes of bodily fluid in response to a negative pressure differential, for example, generated by a fluid collection device. Although some embodiments are described herein as coupled to a vacuum-sealed container (e.g., (etc.), but Figure 20 The illustrated embodiment is configured to be coupled to a syringe that can be operated to generate a negative pressure differential. Furthermore, Figure 20 The fluid transfer device shown is configured to be coupled to a rapid testing device, such as any rapid testing device described herein. In this way, system 1300 can be similar to any system described in detail herein, at least in form and / or function.

[0282] While various embodiments have been described above, it should be understood that they are presented merely by way of example and not as limiting. For example, although some embodiments are described herein as being for obtaining bodily fluids for one or more assays, tests, etc., it should be understood that the embodiments are not limited to this purpose. Any embodiments and / or methods described herein can be used to transfer a flow of bodily fluids to any suitable device in fluid communication with it. Therefore, although specific examples are described herein, the devices, methods, and / or concepts are not intended to be limited to such specific examples.

[0283] While embodiments have been specifically shown and described, it should be understood that various changes in form and detail are possible. Where the schematic diagrams and / or embodiments indicate that specific components are arranged in a particular orientation or location, the arrangement of components may be modified. Although various embodiments have been described as combinations of specific features, concepts, and / or components, other embodiments having any combination or sub-combination of any features, concepts, and / or components from any embodiment described herein are possible.

[0284] The specific configuration of various components can also vary. For example, the size and specific shape of various parts may differ from the illustrated embodiments while still providing the functionality described herein. In some embodiments, changing the size and / or shape of these components can reduce the overall size of the device and / or increase the ergonomics of the device without changing its functionality. In some embodiments, the size and / or shape of various parts can be specifically selected according to the desired or intended use. For example, in some embodiments, a device configured for use with or on a seemingly healthy adult patient may be configured to obtain a first amount of bodily fluid, while a device configured for use with, for example, a seriously ill patient and / or a pediatric patient may be configured to obtain a second amount of bodily fluid less than the first amount. Therefore, it should be understood that unless explicitly stated otherwise in the context, the size, shape, and / or arrangement of embodiments and / or their components may be adapted to a given use.

[0285] The embodiments and / or portions thereof described herein may include components formed from one or more parts, features, structures, etc. When referring to such components, it should be understood that the component may be formed from a single part having any number of segments, regions, sections, and / or features, or may be formed from multiple parts or features. For example, when referring to a structure such as a wall or room, the structure may be considered as a single structure having multiple parts, or as multiple different substructures coupled to form the structure, etc. Thus, a monolithically constructed structure may include, for example, a set of substructures. Such a set of substructures may include multiple parts that are continuous or discontinuous with each other. A set of substructures may also be made from multiple items or components that are manufactured separately and subsequently joined together (e.g., by welding, adhesives, or any suitable method).

[0286] Any embodiment described herein can be used in conjunction with any suitable diagnostic testing apparatus or machine, rapid diagnostic testing apparatus, measuring apparatus (e.g., lateral flow measuring apparatus), etc. Any embodiment described herein may include or be used in conjunction with any suitable fluid transfer device, fluid collection device, and / or fluid storage device, such as a sample reservoir, vessel, container, bottle, adapter, dish, vial, syringe, and / or device (including, for example, its micron and / or nanometer configuration). Furthermore, any embodiment described herein may include any suitable fluid transfer device, transfer adapter, and / or component thereof (such as any device and / or component described in '420 patent, '783 patent, '244 application, '510 publication, '117 publication, '241 patent, '724 patent, '495 patent, '006 publication, '999 application, '074 publication, '380 application, and / or '477 application (the disclosures of which are incorporated herein by reference in their entirety)), may include the fluid transfer device, transfer adapter, and / or component thereof, and / or may be used in conjunction with the fluid transfer device, transfer adapter, and / or component thereof.

[0287] While some of the above embodiments include flow controllers and / or actuators that physically and / or mechanically isolate one or more parts of the fluid transport device, in other embodiments, the fluid transport device does not require physical and / or mechanical isolation of one or more parts of the fluid transport device. For example, in some embodiments, the actuator (such as any of the actuators described herein) can be switched from a first state to a second state, in which an initial volume of bodily fluid can flow from the inlet to the isolation chamber or isolation section, and in the second state, (1) the isolation chamber or isolation section is physically and / or mechanically isolated, and (2) the inlet is in fluid communication with the outlet of the fluid transport device. However, in other embodiments, the actuator and / or any other suitable part of the fluid transport device can be switched from a first state to a second state, in which an initial volume of bodily fluid can flow from the inlet to the isolation chamber or isolation section, and in the second state, the inlet is positioned in fluid communication with the outlet, rather than physically and / or mechanically isolating (or separating) the isolation chamber or isolation section. When such a transfer device is in the second state, one or more features and / or geometries of the transfer device may cause bodily fluids to flow preferentially from the inlet to the outlet, and the initial volume of bodily fluids may be retained in the isolation chamber or isolation section without being physically and / or mechanically isolated or separated.

[0288] Although not shown, any device described herein may include an opening, port, coupler, diaphragm, Luer-Lok, gasket, valve, threaded connector, standard fluid interface, etc. (referred to as a “port” for simplicity) in fluid communication with an isolation chamber. In some such embodiments, a port may be configured to couple to and / or receive any suitable device, reservoir, pressure source, testing device, etc. For example, in some embodiments, a port may be configured to couple to any rapid diagnostic testing device described herein. In some embodiments, a port may be coupled to a negative pressure source, such as a vacuum-sealed container, pump, syringe, etc., to collect a portion or all of a volume of body fluid in an isolation chamber, channel, reservoir, etc., and that volume of body fluid (e.g., the volume before sampling) may be used for other clinical and / or in vitro diagnostic testing purposes. In some embodiments, an isolation chamber may be configured to include a rapid diagnostic testing component (e.g., any rapid diagnostic testing device described herein) integrated into the chamber, thereby allowing at least a portion of the initial volume of body fluid to be used for the test. In other embodiments, the isolation chamber and / or the rapid testing device coupled to or forming part of the isolation chamber may be designed, custom-sized, and configured to be removable and compatible with testing equipment, and / or specifically designed for other types of body fluid testing typically performed on patients with suspected symptoms (e.g., the rapid diagnostic testing device described herein is configured to test for sepsis, etc.). In some embodiments, the port(s) may be coupled to any suitable pressure source or infusion device configured to infuse at least a portion of the initial volume of body fluid isolated in the isolation chamber back to the patient and / or the body fluid source (e.g., in the case of pediatric patients, critically ill patients, patients with hypovolemia, etc.).

[0289] While some embodiments described herein include a rapid diagnostic testing device coupled to or inserted into a portion of the fluid transport device to receive a volume of bodily fluid for testing, in other embodiments, the rapid diagnostic testing device may be integrated into one or more portions of the transport device. For example, any embodiment described herein may include integrated transport and measurement devices, such as one or more devices described in Reference System 800 above. Although the rapid testing device 870 is shown as being disposed or housed within housing 810, in other embodiments, the rapid testing device may be external to the fluid transport device and / or may be at least temporarily coupled to the externality of the fluid transport device.

[0290] Although not shown, in some embodiments, the fluid transfer device may include one or more lumens, channels, flow paths, etc., configured to selectively allow “bypass” flow of bodily fluids, wherein an initial amount or volume of bodily fluid may flow from an inlet through the lumen, channel, flow path, etc., to bypass an isolation chamber (or rapid testing device) and enter a collection device. In some embodiments, the fluid transfer device may include an actuator having, for example, at least three states: a first state in which bodily fluid may flow from the inlet into the isolation chamber (or rapid testing device); a second state in which, after an initial volume has been isolated in the isolation chamber, bodily fluid may flow from the inlet into the outlet; and a third state in which bodily fluid may flow from the inlet into the outlet through a bypass flow path. In other embodiments, as described in detail above with reference to specific embodiments, the transfer device may include a first actuator configured to switch the device between the first and second states, and may include a second actuator configured to switch the device to a bypass configuration, etc. In other embodiments, the transfer device may include any suitable means, features, components, mechanisms, actuators, controllers, etc., configured to selectively place the fluid transfer device in a bypass configuration or state.

[0291] While some methods are described herein as including steps narrated in a specific order, in other embodiments, the order of certain events and / or processes in any method or process described herein may be modified, and such modifications conform to variations of the invention. Additionally, when possible, certain events and / or processes may be performed simultaneously in parallel processes, as well as sequentially as described above. Certain steps may be partially completed or omitted before proceeding to subsequent steps.

[0292] For example, while some devices are described herein as transitioning from a first state to a second state in discrete operations, it should be understood that devices described herein can be configured to transition from a first state to a second state automatically and / or passively, and such transition can occur over a period of time. In other words, in some cases, the transition from the first state to the second state can be relatively gradual. For example, in some cases, the device can begin transitioning from the first state to the second state when the last portion of the initial volume of bodily fluid is transferred into the device (e.g., its initial or isolation section). In some cases, the rate of change during the transition from the first state to the second state can be selectively controlled to achieve one or more desired characteristics associated with the transition. Furthermore, in some such cases, the inflow of the last portion of the initial volume can limit and / or substantially prevent the leakage of bodily fluid already disposed in the initial or isolation section. Thus, although the transition from the first state to the second state can occur within a given time period, the initial or isolation section of the device can still isolate the initial volume of bodily fluid disposed therein.

[0293] Some embodiments and / or methods described herein include one or more electronic devices configured to perform one or more processes included in and / or associated with the fluid transport and / or rapid diagnostic testing systems and methods described herein. The one or more electronic devices described herein (e.g., electronic device 190) can be any suitable hardware-based computing device configured to receive, process, define, and / or store data, such as one or more diagnostic test results, testing criteria on which measurement results are based, predetermined and / or predefined treatment plans, patient profiles, disease profiles, etc. In some cases, one or more electronic devices can receive data associated with diagnostic tests, assays, etc. (e.g., rapid testing device 170) and can be configured to analyze, process, and / or otherwise use the data to generate one or more qualitative and / or quantitative test results associated with the test. In some cases, such testing can be for, for example, sepsis and / or any other disease condition.

[0294] Examples of electronic devices and / or components thereof are provided below. While certain devices and / or components are described, it should be understood that they are presented merely as examples and not as limitations. Any other suitable electronic device with any other suitable components capable of performing the processes, procedures, and / or methods described herein may be used.

[0295] The one or more electronic devices described herein can be, for example, mobile electronic devices (e.g., smartphones, tablets, laptops, and / or any other mobile or wearable devices), PCs, workstations, server equipment or distributed networks of server equipment, virtual servers or machines, virtual private servers, and / or similar devices that perform and / or run as instances or clients on physical servers or groups of servers, and / or any other suitable devices. In some embodiments, the one or more electronic devices may be configured to provide a graphical and / or digital representation of test results generated by any rapid testing apparatus described herein. Furthermore, in some embodiments, based on data associated with and / or representing the test results, the one or more electronic devices may be configured to determine and graphically or digitally present one or more diagnoses, one or more treatment plans, one or more simulations, and / or any other suitable data associated with bodily fluid samples, patients, and / or the medical treatment of patients.

[0296] Components of one or more electronic devices may be contained within a single housing or machine, or may be distributed across and / or among multiple physical machines, virtual machines, and / or any combination thereof. In some embodiments, one or more electronic devices may be stored, operated, executed, and / or otherwise implemented in a cloud computing environment. In some embodiments, one or more electronic devices may include client or mobile devices (e.g., smartphones, tablets, wearable devices, etc.) and servers or one or more host devices and / or may be formed by said devices, which may communicate via one or more networks. Furthermore, one or more electronic devices and / or any components thereof may be included, housed, and / or integrated into any fluid transport device and / or rapid diagnostic testing device or any suitable combination thereof described herein.

[0297] The embodiments described herein include one or more electronic devices that may at least include a memory, a processor, and a communication interface. The memory, processor, and communication interface may be connected and / or electrically coupled (e.g., via a system bus, etc.) such that electrical and / or electronic signals can be transmitted between the memory, processor, and communication interface. One or more electronic devices may also include a database and / or one or more user interface or input / output (I / O) devices and / or may be otherwise operatively coupled to said database and / or user interface or I / O devices, as further described in detail herein.

[0298] In some embodiments, the memory may be, for example, random access memory (RAM), a storage buffer, a hard disk drive, read-only memory (ROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, or suitable combinations thereof. In some embodiments, the memory may be physically housed and / or contained in one or more electronic devices, or may be housed and / or contained by one or more electronic devices, or may be operatively coupled to one or more electronic devices and / or at least their processors. In such embodiments, the memory may, for example, be included and / or distributed in one or more devices, such as server devices, cloud-based computing devices, network computing devices, etc. The memory may be configured to store, for example, one or more software modules and / or code, which may include instructions that cause the processor to perform one or more processes, functions, etc. (e.g., processes, functions, etc. associated with storing, analyzing, and / or presenting data associated with the fluid transport and / or rapid diagnostic test systems and methods described herein).

[0299] The memory and / or at least a portion thereof may include one or more data storage structures (e.g., one or more databases) and / or be able to communicate with one or more of said data storage structures. The database may be any suitable one or more data storage structures, such as tables, repositories, relational databases, object-oriented databases, object-relational databases, structured query language (SQL) databases, extensible markup language (XML) databases, etc. In some embodiments, the database may be housed in a housing, rack, and / or other physical structure including at least memory, a processor, and / or a communication interface. In other embodiments, one or more electronic devices may include any number of databases and / or be operatively coupled to any number of databases. In some embodiments, the database may be configured to store data associated with the fluid transport and / or rapid diagnostic test systems and methods described herein.

[0300] In some implementations, the processor can be a hardware-based integrated circuit (IC) and / or any other suitable processing device configured to run or execute a set of instructions and / or code stored, for example, in memory. For example, the processor can be a general-purpose processor, a central processing unit (CPU), an accelerated processing unit (APU), an application-specific integrated circuit (ASIC), a network processor, a front-end processor, a field-programmable gate array (FPGA), a programmable logic array (PLA), etc. The processor can communicate with memory (and any other components of the electronic device) via any suitable interconnect, system bus, circuitry, etc. The processor may include any number of engines, processing units, cores, etc., configured to execute code, instructions, modules, processes, and / or functions associated with the fluid transport and / or rapid diagnostic test systems and methods described herein.

[0301] In some embodiments, the communication interface can be any suitable hardware-based device that communicates with a processor and memory and / or any suitable software stored in memory and executed by the processor. In some embodiments, the communication interface can be configured to communicate with a network and / or any suitable device that communicates with a network. The communication interface can include one or more wired and / or wireless interfaces, such as a network interface card (NIC), a universal serial bus (USB) card, and / or any other suitable communication and / or peripheral card or device. For example, in some embodiments, the NIC can include, for example, one or more Ethernet interfaces, an optical carrier (OC) interface, an asynchronous transfer mode (ATM) interface, one or more radios (e.g., radio, Radio, near field communication (NFC) radio, etc. In some embodiments, the communication interface may be configured to send data to and / or receive data therefrom (e.g., via one or more networks) any suitable part or device included in the fluid transport and / or measurement apparatus and / or system described herein, one or more peripheral components (e.g., readers, scanners, cameras, analyzers, detectors, I / O devices, etc.), user or client devices (e.g., smartphones, tablets, wearable electronics, PCs, etc.).

[0302] In some implementations, the network can be any type of network, such as a local area network (LAN), a wireless local area network (WLAN), a virtual network such as a virtual local area network (VLAN), a wide area network (WAN), a metropolitan area network (MAN), a microwave access global interconnection network (WiMAX), a telephone network (such as the public switched telephone network (PSTN) and / or the public land mobile network (PLMN)), an intranet, the Internet, a fiber-optic (or fiber-optic) based network, a cellular network, and / or any other suitable network. Furthermore, the network and / or one or more portions thereof can be implemented as wired and / or wireless networks. For example, the network can include one or more networks of any type, such as wired or wireless LANs and the Internet. In some implementations, the network can be any suitable combination of connected and / or otherwise placed in communication (via wired or wireless connections such as USB connections, Ethernet connections, WiFi networks, Bluetooth networks, NFC networks, etc.)

[0303] In some implementations, the user interface may be a display or screen, such as a cathode ray tube (CRT) monitor, a liquid crystal display (LCD) monitor, a light-emitting diode (LED) monitor, etc. In some cases, the display may be a touch-sensitive display (e.g., a touch-sensitive display of a smartphone, tablet, wearable device, PC, etc.). In some cases, the display may provide a user interface for software applications (e.g., mobile applications, PC applications, internet web browsers, etc.) that allow users to operate one or more electronic devices. In some implementations, the user interface may include any suitable type of human-machine interface device, human-computer interface device, batch processing interface, graphical user interface (GUI), etc. In some implementations, the user interface may be any other suitable user interface and / or one or more input / output (I / O) devices, such as holographic displays, wearable devices such as contact lens displays, optical head-mounted displays, virtual reality displays, augmented reality displays, mice, keyboards, etc., or combinations thereof. Therefore, the one or more electronic devices described herein can receive, process, define, and / or store data, such as one or more diagnostic test results, test standards on which measurement results data are based, predetermined and / or predefined treatment plans, patient profiles, disease profiles, etc. In addition, one or more electronic devices may present (e.g., on their display) one or more qualitative and / or quantitative test results associated with any of the rapid diagnostic testing methods described herein (e.g., rapid diagnostic tests for sepsis and / or any other disease condition).

[0304] Some embodiments described herein relate to computer storage products having a non-transitory computer-readable medium (e.g., memory or one or more memories) having instructions or computer code for performing operations of various computer implementations. A computer-readable medium (or processor-readable medium) is non-transitory in the sense that it does not itself include transiently propagating signals (e.g., propagating electromagnetic waves carrying information over transmission media such as space or cables). The medium and computer code (also referred to as code) may be designed and constructed for one or more specific purposes. Examples of non-transitory computer-readable media include, but are not limited to, magnetic storage media such as hard disks, floppy disks, and magnetic tapes; optical storage media such as compact discs / digital video discs (CD / DVD), compact disc read-only memories (CD-ROM), and holographic devices; magneto-optical storage media such as optical discs; carrier signal processing modules; and hardware devices specifically configured to store and execute program code, such as ASICs, ROM devices, RAM devices, and / or programmable logic devices (PLDs). Other embodiments described herein relate to computer program products that may include, for example, the instructions and / or computer code discussed herein.

[0305] Some of the implementation schemes and / or methods described herein can be implemented by software (executing on hardware), hardware, or a combination thereof. Hardware modules may include, for example, general-purpose processors, CPUs, FPGAs, ASICs, etc. Software modules (executing on hardware) can be expressed in various software languages ​​(e.g., computer code), including C, C++, Java, etc. TM Ruby, Visual Basic TM Python TM and / or other object-oriented, procedural, or other programming languages ​​and development tools. Examples of computer code include, but are not limited to, microcode or microinstructions, machine instructions (such as instructions generated by a compiler), code for generating network services, and files containing high-level instructions executed by a computer using an interpreter. For example, implementations may use imperative programming languages ​​(e.g., C, FORTRAN, etc.), functional programming languages ​​(Haskell, Erlang, etc.), logic programming languages ​​(e.g., Prolog), object-oriented programming languages ​​(e.g., Java, C++, etc.) or other suitable programming languages ​​and / or development tools and / or combinations thereof (e.g., Python). TM This is achieved through [methods]. Other instances of computer code include, but are not limited to, control signals, encryption code, and compression code.

Claims

1. A system comprising: Flow-based measuring devices; and A fluid transfer device having an inlet configured to be in fluid communication with a source of bodily fluid and an outlet configured to be in fluid communication with a sample reservoir, the fluid transfer device including an isolation chamber and a port in fluid communication with the isolation chamber. The isolation chamber is configured to be placed in fluid communication with the inlet when the fluid transfer device is in a first state to receive a first volume of body fluid via a first fluid flow path. The outlet is configured to be placed in fluid communication with the inlet when the fluid transfer device is in a second state to receive a second volume of body fluid via a second fluid flow path different from the first fluid flow path. The flow-based measuring device is configured to be coupled to the port when the fluid transfer device is in a third state to receive a portion of the first volume of body fluid via a third fluid flow path different from both the first and second fluid flow paths. The flow-based measuring device is configured to provide an indication associated with the presence of a target analyte in a portion of the first volume of body fluid.

2. The system of claim 1, wherein when the fluid transfer device is in the second state, the first volume is isolated from the first fluid flow path.

3. The system of claim 2, wherein the second volume of body fluid flows through the second fluid flow path, thereby bypassing the isolation chamber and the first volume of body fluid isolated therein.

4. The system of claim 1, wherein the port is configured to transition from a closed state to an open state to place the fluid transfer device in the third state.

5. The system of claim 4, wherein coupling the flow-based measuring device to the port can be used to switch the port from the closed state to the open state.

6. The system of claim 1, wherein the flow-based measuring device is one of a sandwich lateral flow measuring device or a competitive lateral flow measuring device.

7. The system of claim 1, wherein the body fluid is blood and the target analyte is a biomarker in blood for detecting sepsis.

8. The system of claim 7, wherein the biomarker is procalcitonin.

9. The system of claim 7, wherein the biomarker is lactic acid.

10. The system of claim 9, wherein the flow-based assay device includes a conjugation element comprising a matrix of at least one of an enzyme, an antibody, or an aptamer.

11. The system of claim 10, wherein the matrix comprises a combination of chitosanase and trehalase, the combination being configured to stabilize at least a portion of the matrix.

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