Methods for forming and manufacturing cartridges and containers for fluidic device reagent testing
By integrating moisture absorbent elements within cartridge walls, the stability and reliability of lyophilized reagents are enhanced, addressing issues of moisture absorption and manufacturing defects in conventional cartridges, thereby ensuring extended shelf life and accurate assay test results.
Patent Information
- Application Number
- JP2021166168
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2021-09-28
- Filing Date
- 2021-10-08
- Publication Date
- 2025-10-31
- Estimated Expiration
- 2041-10-08
AI Technical Summary
Conventional cartridges for fluidic devices are susceptible to moisture and fluid absorption, leading to contamination and degradation of lyophilized reagents, which affects the shelf life and reliability of assay tests, and can result in inaccurate test results.
Incorporating a moisture absorbent element, such as a desiccant or inert gas, between the inner and outer surfaces of the cartridge walls to stabilize lyophilized reagents, delay wetting, and reduce molding defects.
The solution extends the shelf life of reagents, reduces contamination, and minimizes manufacturing defects, ensuring reliable and accurate assay test results.
Smart Images

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Abstract
Description
[Technical Field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S. Patent Application No. 17 / 072,269, filed October 16, 2020, the entire contents of which are incorporated herein by reference for all purposes.
[0002] technology
[0002] This disclosure relates to cartridges, such as disposable assay cartridges, and related devices, systems, and methods of making and using such cartridges. Exemplary applications of related cartridges include use in portable assay systems for fluid reagent testing. [Background technology]
[0003] background
[0003] Fluid analysis of biological materials for assay testing and detection may require a series of processing steps. These processing steps may require a particular fluid or fluids to contact reaction areas at different times and in various sequences. A single fluid sample may undergo various processes or steps before contacting the reaction areas.
[0004]
[0004] Recent developments in the field of diagnostic testing include portable diagnostic fluidic devices capable of performing a variety of procedures that are typically performed manually by a technician in a laboratory. The portable diagnostic fluidic devices can include a base unit for receiving cartridges for performing assay tests. For example, cartridges can be prepared to test for blood-borne diseases, food-borne germs, microorganisms such as bacteria or viruses, and the like.
[0005]
[0005] In fluidic devices in which multiple such processing steps are performed sequentially, the cartridge may include multiple chambers, each containing a reagent used in the assay test. To maximize shelf life and reliability, reagents that are unstable over time may be dehydrated or lyophilized. Lyophilized reagents may be stored in one or more chambers of the cartridge and dissolved in a fluid immediately prior to use.
[0006] However, lyophilized reagents are susceptible to fluid and moisture within the cartridge. For example, a chamber containing a fluid can affect an adjacent chamber containing a lyophilized reagent, absorbing the fluid and / or associated fluid moisture. Additionally, molded cartridges are susceptible to cracking and defects depending on the thickness of the chamber. Due to this susceptibility, any manufacturing defects in conventional cartridges, environmental conditions, or a combination thereof can dilute, contaminate, spoil, or otherwise compromise the lyophilized reagents or assay materials in a way that reduces or eliminates their effectiveness over time. Such problems can lead to financial losses for testing facilities that must dispose of unusably damaged materials before they can be deployed. Additionally, if such defective materials are used in actual testing, they can produce test results that are potentially inaccurate and unreliable. This, in turn, can further adversely affect the medical testing and treatment of individual patients, in addition to the potential impact on larger public health concerns. Summary of the Invention [Problem to be solved by the invention]
[0007] overview
[0007] Therefore, there is a need to stably store reagents (e.g., lyophilized reagents) within multiple chambers of an assay cartridge, extend the shelf life of reagent detection, delay wetting of the reagents by fluids, and reduce molding defects (e.g., vacuum voids) in the assay cartridge. [Means for solving the problem]
[0008] In some embodiments, a cartridge for detecting one or more properties of a fluid in a diagnostic assay system includes a plurality of chambers, at least one of the plurality of chambers includes a wall, the wall including an intermediate portion disposed between an outer surface and an inner surface of the wall.
[0009] In some embodiments, the intermediate portion includes a moisture absorbent element configured to extend the shelf life of detection of the reagent, hi some embodiments, the moisture absorbent element includes a desiccant, a dehumidifying material, silica gel, calcium oxide, calcium chloride, zeolite, charcoal, or any combination thereof.
[0010] In some embodiments, the intermediate portion includes a dummy material configured to retard wetting of the reagent by the fluid, hi some embodiments, the dummy material includes a monohydrate, a disaccharide, a sugar, trehalose, sucrose, glucose, or any combination thereof.
[0011] In some embodiments, the intermediate portion is configured to reduce internal stresses and / or strains in the cartridge. For example, the intermediate portion can include a void configured to reduce molding defects (e.g., vacuum voids, air pockets, sink marks, cracks, fractures, etc.) resulting from internal stresses and / or strains in the cartridge.
[0012] In some embodiments, the middle portion comprises an inert gas, which can include a noble gas, dinitrogen (N2), carbon dioxide (CO2), or a combination thereof.
[0013] In some embodiments, the intermediate portion has a uniform width. In some embodiments, the width of the intermediate portion is between 1.0 mm and 5.0 mm. In some embodiments, the width of the intermediate portion is between 10% and 90% of the width of the wall.
[0014] In some embodiments, a subset of the plurality of chambers includes a wall, and the wall corresponding to each chamber of the subset includes an intermediate portion disposed between an outer surface and an inner surface of the wall, hi some embodiments, each intermediate portion includes a moisture absorbing element, a dummy material, an air gap, an inert gas, or any combination thereof.
[0015]
[0015] In some embodiments, the cartridge further includes a rotor configured to rotate the plurality of chambers about an axis of rotation.
[0016] In some embodiments, the cartridge further includes a reagent surrounded by a wall of at least one of the plurality of chambers. In some embodiments, the reagent is a lyophilized reagent. In some embodiments, the cartridge further includes a lid coupled to the plurality of chambers and configured to seal the plurality of chambers.
[0017] In some embodiments, the fluid is enclosed in one of a plurality of chambers that is external to the intermediate portion and external to the chamber that surrounds the reagent.
[0018] In some embodiments, a diagnostic assay system includes a cartridge, a syringe system, a first actuator, a second actuator, and a controller. The cartridge is configured to receive a fluid and includes a plurality of chambers and a rotor. The rotor includes a rotor port in fluid communication with at least one of the plurality of chambers. The syringe system is coupled to the cartridge and configured to provide a fluid to the rotor port. The syringe system includes a syringe barrel having a barrel port and a syringe plunger configured to inject and withdraw the fluid. The first actuator is coupled to the cartridge and configured to rotate the rotor port to align with the barrel port. The second actuator is coupled to the syringe system and configured to translate the syringe plunger. The controller is coupled to the first actuator and the second actuator and configured to detect one or more characteristics of the fluid based on interaction between the fluid and one or more lyophilized reagents. One of the plurality of chambers includes a wall surrounding the lyophilized reagent. The wall includes an intermediate portion disposed between an outer surface and an inner surface of the wall.
[0019] In some embodiments, the intermediate portion includes a moisture-wicking element configured to extend the shelf life of detection of the reagent. In some embodiments, the intermediate portion includes a dummy material configured to retard wetting of the reagent by a fluid. In some embodiments, the intermediate portion is configured to reduce internal stresses and / or distortions in the cartridge. For example, the intermediate portion may include a void configured to reduce molding defects (e.g., vacuum voids, air pockets, sink marks, cracks, fractures, etc.) resulting from internal stresses and / or distortions in the cartridge. In some embodiments, the intermediate portion includes an inert gas. In some embodiments, the intermediate portion is configured to reduce contamination within the cartridge. For example, the intermediate portion may include an inert gas configured to reduce contamination within the cartridge.
[0020] In some embodiments, a method for detecting one or more properties of a fluid in a diagnostic assay system includes forming a cartridge having a plurality of chambers and a rotor. A first chamber of the plurality of chambers includes a wall having an intermediate portion disposed between an outer surface and an inner surface of the wall. In some embodiments, the method further includes disposing a reagent in the first chamber. In some embodiments, the method further includes interacting a fluid with the reagent in the first chamber. In some embodiments, the intermediate portion includes an inert gas.
[0021] In some embodiments, the method further includes disposing a moisture absorbing element, dummy material, air, or an inert gas in the intermediate portion to extend the effective period for the fluid to interact with the reagent. In some embodiments, the method further includes detecting one or more properties of the fluid based on the interaction of the fluid with the reagent.
[0022] In some embodiments, the method further includes interacting the fluid with a second reagent in a second chamber of the plurality of chambers. The second chamber includes a wall having a moisture-wicking element, a dummy material, a void, or an inert gas disposed between an outer surface and an inner surface of the wall. In some embodiments, the method further includes detecting one or more properties of the fluid based on the interaction of the fluid with the reagent and the second reagent.
[0023]
[0023] Implementations of any of the technologies described above may include an apparatus, a device, a system, a method, and / or a process. Details of one or more implementations are set forth in the accompanying drawings and the description below. Other features will be apparent from the description and drawings, and from the claims.
[0024]
[0024] Further features and exemplary aspects of the embodiments, as well as the structure and operation of various embodiments, are described in detail below with reference to the accompanying drawings. It should be noted that the embodiments are not limited to the specific embodiments described herein. Such embodiments are presented herein for illustrative purposes only. Additional embodiments will be apparent to those skilled in the art based on the teachings contained herein.
[0025] BRIEF DESCRIPTION OF THE DRAWINGS
[0025] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments and, together with the description, serve to explain the principles of the embodiments and to enable those skilled in the relevant art to make and use the embodiments. [Brief explanation of the drawings]
[0026] [Figure 1]
[0026] FIG. 1 is a schematic perspective view of a diagnostic assay system including an assay cartridge, according to an exemplary embodiment. [Figure 2]
[0027] 2 is a partially schematic perspective exploded view of the diagnostic assay system and assay cartridge of FIG. 1, according to an exemplary embodiment. [Figure 3]
[0028] FIG. 3 is a schematic bottom perspective view of the assay cartridge of FIGS. 1 and 2, according to an exemplary embodiment. [Figure 4]
[0029] FIG. 4 is a schematic top perspective view of the assay cartridge shown in FIG. 3, according to an exemplary embodiment. [Figure 5]
[0030] 5 is a schematic close-up top view of a pair of chambers with an intermediate portion shown in FIG. 4 according to an exemplary embodiment. [Figure 6]
[0031] 5 is a schematic top close-up view of the chamber with the intermediate portion shown in FIG. 4 according to an exemplary embodiment. [Figure 7]
[0032] 1 illustrates a flow diagram for detecting one or more properties of a fluid, according to an exemplary embodiment; DETAILED DESCRIPTION OF THE INVENTION
[0027]
[0033] Features and exemplary aspects of the embodiments will become more apparent from the detailed description set forth below when taken in conjunction with the drawings, in which like reference numerals identify corresponding elements throughout. Within the drawings, like reference numerals generally represent identical, functionally similar, and / or structurally similar elements. Additionally, the left-most digit(s) of a reference number generally identifies the drawing in which that reference number first appears. Unless otherwise indicated, the drawings provided throughout this disclosure should not be construed as drawings to scale.
[0028] Detailed Description
[0034] This specification discloses one or more embodiments incorporating the features of this invention. The disclosed embodiments are merely exemplary of the invention. The scope of the invention is not limited to the disclosed embodiments. The invention is defined by the claims appended hereto.
[0029]
[0035] References to the described embodiments, and to "one embodiment," "embodiment," "exemplary embodiment," and the like herein, indicate that the described embodiment may include a particular feature, structure, or characteristic, but not all embodiments necessarily include the particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in the context of an embodiment, it should be understood that it is within the knowledge of one of ordinary skill in the art to achieve such feature, structure, or characteristic in the context of other embodiments, whether or not explicitly described.
[0030]
[0036] Spatially relative terms such as "beneath," "below," "lower," "above," "on," "upper," and the like may be used herein for ease of description to describe the relationship of one element or feature to another, as illustrated in the figures. The spatially relative terms are intended to encompass various orientations of the device during use or operation in addition to the orientation shown in the figures. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein may be similarly interpreted accordingly.
[0031]
[0037] As used herein, the terms "about" or "substantially" or "nearly" represent a given quantity value that may vary based on a particular technique. Based on a particular technique, the terms "about" or "substantially" or "nearly" may represent a given quantity value that varies within a range of, for example, 1 to 15% of the value (e.g., ±1%, ±2%, ±5%, ±10%, or ±15% of the value).
[0032]
[0038] As used herein, the term "void" refers to a gap or void in a material that can be filled with a gas (e.g., air, inert gases, noble gases, dinitrogen (N), carbon dioxide (CO)) or evacuated (e.g., vacuum).
[0033]
[0039] As used herein, the term "inert gas" refers to a gas that does not undergo chemical reaction under a given set of conditions. An inert gas is not necessarily an elemental gas, but can be a compound gas (e.g., carbon dioxide (CO2)).
[0034]
[0040] As used herein, the term "noble gas" refers to odorless, colorless monatomic gases with low chemical reactivity, including helium (He), neon (Ne), argon (Ar), krypton (Kr), xenon (Xe), and radon (Rn).
[0035]
[0041] Embodiments of the present disclosure may be implemented in hardware, firmware, software, or any combination thereof. Embodiments of the present disclosure may also be implemented as instructions stored on a machine-readable medium, which may be read and executed by one or more processors. A machine-readable medium may include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computing device). For example, a non-transitory machine-readable storage medium may include read-only memory (ROM), random-access memory (RAM), magnetic storage media, optical storage media, flash memory (solid-state) devices, or any combination thereof. Transmission media may include electrical, optical, acoustic, or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.), and other signals. Furthermore, firmware, software, routines, and / or instructions may be described herein as performing certain acts. However, it should be understood that such description is merely for convenience and that such acts actually result from a computing device, processor, controller, or other device executing the firmware, software, routines, instructions, etc.
[0036]
[0042] Exemplary Diagnostic Assay Systems
[0043] As noted above, fluid analysis of biological materials (e.g., blood, proteins, DNA, etc.) for assay testing and detection can include any step in a series of processing steps (e.g., mixing, heating, cooling, detection, etc.). These processing steps can include contacting a particular fluid or fluids with reaction areas at different times and in various sequences. A single fluid sample can undergo various steps before contacting a reaction area.
[0037]
[0044] In some use cases, the portable diagnostic fluidic device can be configured to perform various procedures that are typically performed manually by a technician in a laboratory. The portable diagnostic fluidic device can include a base unit for receiving cartridges for performing assay tests. For example, cartridges can be provided to test for blood-borne diseases, food-borne bacteria, or microorganisms such as bacteria or viruses.
[0038]
[0045] In fluidic devices in which multiple such processing steps are performed sequentially, the cartridge can include multiple chambers, each housing a reagent (e.g., polymerase chain reaction (PCR) primers, enzymes, and / or certain compounds) used in the assay test. Reagents that are unstable over time can be dehydrated or lyophilized (e.g., freeze-dried, cryodesiccated, etc.) to improve shelf life and reliability over time and reduce the rate of natural degradation. Lyophilized reagents can be stored in one or more chambers of the cartridge and dissolved in a fluid immediately prior to use.
[0039]
[0046] However, lyophilized reagents can be susceptible to fluid and moisture within the cartridge. For example, a chamber containing fluid can affect (e.g., contaminate) an adjacent chamber containing lyophilized reagent that absorbs the fluid and / or associated fluid moisture. Also, molded cartridges, such as those formed by injection molding, can be susceptible to cracks and defects (e.g., vacuum voids) depending on the thickness of the chamber.
[0040]
[0047] Embodiments of the cartridge device and diagnostic assay system described below can stably store reagents (e.g., lyophilized reagents) within multiple chambers of the assay cartridge, extend the shelf life of reagent detection, delay wetting of the reagents by fluids, and reduce molding defects (e.g., vacuum voids) in the cartridge.
[0041]
[0048] 1 and 2 illustrate a diagnostic assay system 100 including an assay cartridge 200 according to various exemplary embodiments. FIG. 1 is a schematic perspective view of the diagnostic assay system 100 including the assay cartridge 200 according to an exemplary embodiment. FIG. 2 is a schematic perspective exploded view of the diagnostic assay system 100 and assay cartridge 200 of FIG. 1 according to an exemplary embodiment. The diagnostic assay system 100 can be configured to detect one or more properties of a fluid. The diagnostic assay system 100 can be further configured to control one or more fluids into or out of one or more ambient chambers 232, 234, 236, 238, 240 of the assay cartridge 200. In some embodiments, the diagnostic assay system 100 can be a portable, compact (e.g., handheld) unit configured to accept one or more disposable assay cartridges 200 for different fluid diagnostic tests. For example, each disposable assay cartridge 200 can be selectively configured to detect a particular property of a fluid (e.g., blood, food, or biological disease markers, bacteria, and / or viruses).
[0042]
[0049] 1 and 2, diagnostic assay system 100 can include assay cartridge 200, syringe system 122, first actuator 130 (e.g., a rotary actuator), second actuator 124 (e.g., a linear actuator), and controller 114. In some embodiments, diagnostic assay system 100 can detect one or more properties of a fluid based on the interaction of the fluid with reagents (e.g., lyophilized reagents 260-264) in one or more surrounding chambers 232, 234, 236, 238, 240 of assay cartridge 200. For example, the controller 114 of the diagnostic assay system 100 can detect (e.g., chemically, optically, thermally, mechanically, magnetically, acoustically, etc.) the interaction of fluid from the syringe system 122 with one or more reagents (e.g., lyophilized reagents 260-264) in one or more surrounding chambers 232, 234, 236, 238, 240 of the assay cartridge 200, and identify one or more characteristics of the fluid (e.g., marker, DNA, cDNA, RNA, disease, bacteria, viruses, etc.) based on the detected interaction.
[0043]
[0050] Assay cartridge 200 can be configured to provide one or more reagents (e.g., lyophilized reagents 260-264) in one or more peripheral chambers 232, 234, 236, 238, 240 for detecting one or more properties of a fluid within diagnostic assay system 100. As shown in FIG. 2 , assay cartridge 200 can include a bottom surface 202, a top surface 204, a sidewall surface 206, a central chamber 230, one or more peripheral chambers 232, 234, 236, 238, 240, and a rotor 218. In some embodiments, one or more peripheral chambers 232, 234, 236, 238, 240 can surround and isolate reagents (e.g., lyophilized reagents 260-264) for one or more different fluid diagnostic tests.
[0044]
[0051] The rotor 218 can be configured to rotate the plurality of chambers 230, 232, 234, 236, 238, 240 about a rotational axis 219. The rotor 218 can be further configured to couple to the syringe system 122 and the first actuator 130 (e.g., a rotary actuator) for rotation about the rotational axis 219. In some embodiments, the rotor 218 can be a cylindrical rotor. The rotor 218 can include one or more rotor ports 218P, one or more rotor grooves 218W, and / or one or more rotor tabs 218T. In some embodiments, the rotor port 218P can be in fluid communication with one or more of the plurality of chambers 230, 232, 234, 236, 238, 240. For example, as shown in FIG. 3 , rotor port 218P can be in fluid communication with one or more channels 250, 251, 252, 253, 254 and / or channel ports 256, 257, 258, 259. In some embodiments, rotor groove 218W and / or rotor tabs 218T can be coupled to first actuator 130 (e.g., a rotational actuator) to rotate rotor 218 (e.g., stepwise, sequentially, etc.) about rotation axis 219. For example, one or more rotor ports 218P can be rotated sequentially (e.g., in a predetermined order) to align with barrel ports 122P of syringe system 122. Details and various embodiments of assay cartridge 200 are further described below with reference to FIGS. 3-6.
[0045]
[0052] The syringe system 122 can be configured to provide fluid to the assay cartridge 200. In some embodiments, the syringe system 122 can be coupled to the assay cartridge 200 and provide fluid to one or more rotor ports 218P. As shown in FIG. 2 , the syringe system 122 can include an inner cartridge holder 116 (e.g., a hollow cylinder), a cartridge seal plate 118 (e.g., a glass disk), an outer cartridge holder 120 with a syringe barrel 122B and a barrel port 122P, a plunger shaft 126, and a syringe plunger 128 (e.g., an elastomer). In some embodiments, the syringe system 122 can be coupled to the assay cartridge 200, the first actuator 130, the second actuator 124, and the controller 114 for multiple fluid tests.
[0046]
[0053] The inner cartridge holder 116 can be configured to support the assay cartridge 200 and enable rotation of the rotor 218 about a rotation axis 219. In some embodiments, the inner cartridge holder 116 can be coupled to the assay cartridge 200 and provide fixed support for the assay cartridge 200. For example, as shown in FIG. 2 , the inner cartridge holder 116 can be a hollow cylinder that is coupled to the outer cartridge holder 120 and supports a top surface 204 (e.g., a flange) of the rotor 218 to enable rotation of the rotor 218 about the rotation axis 219 relative to the outer cartridge holder 120.
[0047]
[0054] The cartridge sealing plate 118 can be configured to seal against the bottom surface 202 of the assay cartridge 200. In some embodiments, the cartridge sealing plate 118 can contact the bottom surface 202 to form a fluid-tight (e.g., water-tight) seal. For example, as shown in FIGS. 2 and 3 , the cartridge sealing plate 118 can be a circular plate (e.g., glass) that is bonded to the bottom surface 202 to form a fluid-tight seal with the channels 250, 251, 252, 253, 254, the bottom panel 255, and the channel ports 256, 257, 258, 259 disposed (e.g., recessed) in the bottom surface 202. The cartridge sealing plate 118 can be formed or otherwise made from a material that is inert to fluids and / or reagents, such as glass, titanium, stainless steel, or the like, any combination thereof, or another material having a surface coating or treatment that renders the surface inert, such as polyethylene, polytetrafluoroethylene (PTFE), or the like, or any combination thereof.
[0048]
[0055] The outer cartridge holder 120 can be configured to support the inner cartridge holder 116 and the assay cartridge 200. The outer cartridge holder 120 can be further configured to provide fluid to the assay cartridge 200 through a barrel port 122P of the syringe barrel 122B. As shown in FIGS. 1 and 2 , a syringe plunger 128 can be coupled to the barrel port 122P, and the plunger shaft 126 can be coupled to a second actuator 124, to move fluid into or out of one or more rotor ports 218P. In some embodiments, the plunger shaft 126 can displace (e.g., translate) the syringe plunger 128 (e.g., an elastomer) relative to the syringe barrel 122B to move and / or mix one or more fluids contained within one or more ambient chambers 232, 234, 236, 238, 240.
[0049]
[0056] The first actuator 130 can be configured to rotate one or more rotor ports 218P of the rotor 218 to align with the barrel ports 122P of the syringe barrel 122B. In some embodiments, the first actuator 130 can include a rotary actuator (e.g., mechanical, electric, electromechanical, pneumatic, hydraulic, spring, shape memory, supercoiled polymer, vacuum, piezoelectric, stepper motor, servo motor, torque motor, etc.). For example, the rotary actuator 130 can be coupled to the rotor grooves 218W and / or rotor tabs 218T to rotate the rotor 218 (e.g., stepwise, sequentially, etc.) about the rotation axis 219. For example, one or more rotor ports 218P can be rotated sequentially (e.g., in a predetermined order) by the first actuator 130 (e.g., a rotary actuator) to align with the barrel ports 122P of the syringe system 122.
[0050]
[0057] The second actuator 124 can be configured to translate the syringe plunger 128 of the syringe system 122 to inject and withdraw fluid from one or more rotor ports 218P. In some embodiments, the second actuator 124 can include a linear actuator (e.g., mechanical, electric, electromechanical, pneumatic, hydraulic, spring, shape memory, supercoiled polymer, vacuum, piezoelectric, stepper motor, servo motor, linear motor, etc.). For example, the linear actuator 124 can be coupled to the syringe plunger 128 via the plunger shaft 126 to translate the syringe plunger 128 toward and away from the syringe barrel 122B to inject and withdraw fluid from the barrel port 122P and one or more rotor ports 218P. In some embodiments, the second actuator 124 can generate pressure (e.g., positive pressure, negative pressure (vacuum)) within the syringe barrel 122B.
[0051]
[0058] The controller 114 can be configured to detect one or more properties of the fluid based on the interaction of the fluid with one or more reagents (e.g., lyophilized reagents 260-264) in the ambient chambers 232, 234, 236, 238, 240. In some embodiments, the controller 114 can include one or more computer processors (e.g., central processing units (CPUs)), microcontroller units (MCUs), etc., and / or one or more sensors (e.g., chemical sensors, optical sensors, thermal sensors, mechanical sensors, magnetic sensors, acoustic sensors, etc.), or other dedicated application-specific electronics or similar circuitry. In some embodiments, the controller 114 can be coupled to the first actuator 130 and the second actuator 124. For example, the controller 114 may be coupled (e.g., electrically, wirelessly, mechanically, etc.) to the rotary actuator 130 to control the rotation of the rotor 218 about the axis of rotation 219 relative to the syringe system 122, and may be coupled (e.g., electrically, wirelessly, mechanically, etc.) to the linear actuator 124 to control the translation of the syringe plunger 128 toward and away from the syringe barrel 122B.
[0052]
[0059] In some embodiments, the controller 114 can detect (e.g., chemically, optically, thermally, mechanically, magnetically, acoustically, etc.) an interaction between the fluid from the syringe system 122 and one or more reagents (e.g., lyophilized reagents 260-264) in one or more ambient chambers 232, 234, 236, 238, 240 of the assay cartridge 200. For example, the controller 114 can identify one or more characteristics of the fluid (e.g., marker, DNA, cDNA, RNA, disease, bacteria, virus, etc.) based on the detected interaction. In some embodiments, one or more properties of the fluid can be detected by the controller 114 based on a first interaction of the fluid with a first reagent (e.g., lyophilized reagents 260-264) in one or more of the surrounding chambers 232, 234, 236, 238, 240 and a second interaction of the fluid with a second reagent (e.g., lyophilized reagents 260-264) in one or more of the surrounding chambers 232, 234, 236, 238, 240. For example, the fluid can interact with a first lyophilized reagent 262 in the surrounding chamber 236 and a second lyophilized reagent 263 in the surrounding chamber 238. The controller 114 can detect one or more properties of the fluid. The detected properties can be based at least in part on the results of either or both interactions.
[0053]
[0060] In some embodiments, the assay cartridge 200 may include a lid (e.g., similar to the cartridge sealing plate 118) configured to seal against the top surface 204 of the assay cartridge 200, sealing one or more of the peripheral chambers 232, 234, 236, 238, 240. In some embodiments, the lid (e.g., similar to the cartridge sealing plate 118) may contact the top surface 204 to form a fluid-tight (e.g., water-tight) seal for the one or more peripheral chambers 232, 234, 236, 238, 240. In some embodiments, the lid may include a sealant (e.g., a metal foil, a heat seal, a sealing plate, an epoxy seal, etc.).
[0054]
[0061] Exemplary Cartridge Device
[0062] As shown in Figures 1 and 2, the diagnostic assay system 100 can include an assay cartridge 200. Figures 3-6 illustrate assay cartridge 200 according to various exemplary embodiments. Figure 3 is a schematic bottom perspective view of assay cartridge 200 of Figures 1 and 2 according to an exemplary embodiment. Figure 4 is a schematic top perspective view of assay cartridge 200 of Figure 3 according to an exemplary embodiment.
[0055]
[0063] The assay cartridge 200 can be configured to provide one or more reagents (e.g., lyophilized reagents 260-264) within one or more ambient chambers 232, 234, 236, 238, 240 for detecting (e.g., chemically, optically, thermally, mechanically, magnetically, acoustically, etc.) one or more characteristics (e.g., markers, DNA, cDNA, RNA, diseases, bacteria, viruses, etc.) of fluids within the diagnostic assay system 100. In some embodiments, the one or more ambient chambers 232, 234, 236, 238, 240 can surround and isolate one or more reagents (e.g., lyophilized reagents 260-264) for one or more different fluid diagnostic tests.
[0056]
[0064] 3 and 4, assay cartridge 200 can include a bottom surface 202, a top surface 204, sidewall surfaces 206, a central chamber 230, one or more peripheral chambers 232, 234, 236, 238, 240, channels 250, 251, 252, 253, 254, a bottom panel 255, channel ports 256, 257, 258, 259, and a rotor 218 with rotor ports 218P, rotor grooves 218W, and rotor tabs 218T. In some embodiments, one or more of the peripheral chambers 232, 234, 236, 238, 240 can include an intermediate portion 270. 4, any of the ambient chambers 232, 234, 236, 238, 240 may include chamber walls 233, 235, 237, 239 with an intermediate portion 270, e.g., a gap, a moisture-wicking element, a dummy material, or an inert gas. In some embodiments, the assay cartridge 200 may include an intermediate wall, gap, material, or inert gas (e.g., intermediate portion 270) within one or more portions of the rotor 218. For example, as shown in FIG. 4, intermediate portion 271 (e.g., similar to intermediate portion 270) may be disposed between the radially inner and outer peripheries of the sidewall surface 206 and between the top surface 204 and the bottom panel 255.
[0057]
[0065] 3, channels 250, 251, 252, 253, 254, bottom panel 255, and channel ports 256, 257, 258, 259 can be disposed (e.g., recessed) in bottom surface 202 of assay cartridge 200. In some embodiments, cartridge sealing plate 118 can form a fluid-tight (e.g., water-tight) seal between channels 250, 251, 252, 253, 254, bottom panel 255, and channel ports 256, 257, 258, 259 for transferring fluid to one or more surrounding chambers 232, 234, 236, 238, 240. In some embodiments, channels 250, 251, 252, 253, 254 can be fluidly coupled to channel ports 256, 257, 258, 259. 3, channel 250 can be fluidly connected to channel port 256, channel 251 can be fluidly connected to channel port 257, and channel 252 can be fluidly connected to channel 258. In some embodiments, one or more ambient chambers 232, 234, 236, 238, 240 can be in fluid communication with one or more rotor ports 218P. For example, as shown in FIG. 3, one or more channel ports 256, 257, 258, 259 can be in fluid communication with one or more rotor ports 218P and can transport fluid to one or more ambient chambers 232, 234, 236, 238, 240 via channels 250, 251, 252, 253, 254 and / or bottom panel 255.
[0058]
[0066] As shown in FIG. 4, the assay cartridge 200 can include one or more peripheral chambers 232, 234, 236, 238, 240 dispersed around a central chamber 230. The peripheral chambers 232, 234, 236, 238, 240 can be configured to surround one or more reagents and provide a reaction area for fluids for diagnostic fluid testing. In some embodiments, the peripheral chambers 232, 234, 236, 238, 240 can be disposed between the bottom surface 202 and the top surface 204. For example, as shown in FIG. 4, the peripheral chambers 232, 234, 236, 238, 240 can be disposed between a bottom panel 255 (e.g., a recess in the bottom surface 202 that forms a fluid channel) and the top surface 204.
[0059]
[0067] In some embodiments, one or more reagents 260, 261, 262, 263, 264 can be disposed within peripheral chambers 232, 234, 236, 238, 240, respectively. For example, as shown in FIG. 4, each peripheral chamber 232, 234, 236, 238, 240 can surround a reagent 260, 261, 262, 263, 264, respectively. In some embodiments, one or more reagents 260, 261, 262, 263, 264 can be lyophilized reagents. For example, as shown in FIGS. 4 and 6, lyophilized reagent 264 can be disposed within peripheral chamber 240 within inner wall surface 241b. In some embodiments, the central chamber 230 can receive fluid from the syringe system 122 and transfer the fluid along with one or more reagents (e.g., lyophilized reagents 260-264) to one or more of the surrounding chambers 232, 234, 236, 238, 240 for a diagnostic fluid test. In some embodiments, one or more of the surrounding chambers 232, 234, 236, 238, 240 can remain open (e.g., contain no reagents). For example, one or more of the open surrounding chambers 232, 234, 236, 238, 240 can receive a mixed fluid reagent for subsequent diagnostic fluid testing and / or for detection of the mixed fluid reagent by the controller 114 (e.g., by a sensor).
[0060]
[0068] In some embodiments, a reagent (e.g., lyophilized reagents 260-264) in one or more of the peripheral chambers 232, 234, 236, 238, 240 can interact with a fluid. For example, a fluid can be disposed in the central chamber 230 and / or one or more cartridge ports 218P and distributed to one or more of the peripheral chambers 232, 234, 236, 238, 240 via one or more channels 250, 251, 252, 253 and / or one or more channel ports 256, 257, 258, 259. In some embodiments, the fluid can interact with a second reagent (e.g., lyophilized reagents 260-264) in a second peripheral chamber 232, 234, 236, 238, 240. For example, as shown in FIGS. 3 and 4, fluid can interact with surrounding chambers 238 and 240 containing lyophilized reagent 263 via channels 253, 254 and channel port 259.
[0061]
[0069] 4, the peripheral chambers 232, 234, 236, 238, 240 can be separated and / or surrounded by chamber walls 233, 235, 237, 239, 241. The chamber walls 233, 235, 237, 239, 241 can be configured to define portions of the peripheral chambers 232, 234, 236, 238, 240. In some embodiments, one or more of the chamber walls 233, 235, 237, 239, 241 can be coupled to the sidewall surface 206. In some embodiments, the chamber walls 233, 235, 237, 239, 241 can be radial walls, circumferential walls, and / or U-shaped walls, as shown in FIG. In some embodiments, one or more of the chamber walls 233, 235, 237, 239, 241 can have a U-shape with an arcuate portion disposed between two legs that are coupled to the rotor 218. For example, as shown in Figures 4-6, the free ends of both legs of the U-shape can be coupled to the sidewall surface 206 between the top surface 204 and the bottom panel 255.
[0062]
[0070] As shown in FIG. 4 , one or more chamber walls 231, 233, 235, 237, 239 of the surrounding chambers 232, 234, 236, 238, 240 can include an intermediate portion 270. The intermediate portion 270 can be configured to extend the shelf life of detection of a reagent (e.g., lyophilized reagents 260-264). The intermediate portion 270 can also be configured to retard wetting of the reagent (e.g., lyophilized reagents 260-264) by a fluid. For example, wetting of the lyophilized or dried reagent (e.g., lyophilized reagents 260-264) can be reduced or retarded compared to a solid chamber wall that does not include an intermediate wall, gap, material, or inert gas (e.g., intermediate portion 270). The intermediate portion 270 can also be configured to reduce molding defects in the assay cartridge 200. For example, the intermediate gap (e.g., void 272) can reduce or mitigate harmful molding defects, such as vacuum voids, air pockets, sink marks, cracks, and fractures, by reducing internal stresses and / or strains in the mold during manufacturing (e.g., molding). Furthermore, the intermediate gap (e.g., void 272) can reduce the probability or number of molding defects (e.g., vacuum voids, air pockets, sink marks, cracks, and fractures) during manufacturing. The intermediate portion 270 can be disposed between the outer wall surfaces 233a, 235a, 237a, 239a, and 241a and the inner wall surfaces 233b, 235b, 237b, 239b, and 241b of the chamber walls 231, 233, 235, 237, and 239, respectively. In some embodiments, the width of the intermediate portion 270 can be uniform. For example, the width of the intermediate portion 270 can be constant across the entire chamber walls 233, 235, 237, 239, and 241. In some embodiments, the width of intermediate portion 270 can be at least 1.0 mm. For example, intermediate portion 270 can be between about 1.0 mm and about 2.0 mm. In some embodiments, intermediate portion 270 can have a width between 1.0 mm and 5.0 mm. In some embodiments, intermediate portion 270 can have a width between 10% and 90% of the width of each chamber wall 231, 233, 235, 237, and 239. For example, the width can be between 35% and 65% of the width of each chamber wall 231, 233, 235, 237, and 239.
[0063]
[0071] 4, each chamber wall 231, 233, 235, 237, 239 of the ambient chambers 232, 234, 236, 238, 240 can include an intermediate portion 270. In some embodiments, the intermediate portion 270 can include a void and / or a partition wall. For example, as shown in FIGS. 5 and 6, the intermediate portion 270 can include a void 272 (e.g., air, an inert gas) and / or a partition wall 274 (e.g., a moisture absorbing element, a dummy material). In some embodiments, one or more of the ambient chambers 232, 234, 236, 238, 240 can include chamber walls 233, 235, 237, 239, 241 with the void 272 disposed between the outer wall surface 233a, 235a, 237a, 239a, 241a and the inner wall surface 233b, 235b, 237b, 239b, 241b, respectively. In some embodiments, one or more of the ambient chambers 232, 234, 236, 238, 240 can include chamber walls 233, 235, 237, 239, 241 with partitions 274 disposed between outer wall surfaces 233a, 235a, 237a, 239a, 241a and inner wall surfaces 233b, 235b, 237b, 239b, 241b, respectively.
[0064]
[0072] In some embodiments, the fluid for the fluid reagent test can be enclosed in one of the peripheral chambers 232, 234, 236, 238, 240, which is external to the intermediate portion 270 and external to the chamber walls 233, 235, 237, 239, 241. For example, the fluid can be enclosed in the peripheral chamber 236, which is external to the intermediate portion 270 and external to the chamber wall 239 of the peripheral chamber 238.
[0065]
[0073] Figure 5 is a schematic, enlarged top view of the peripheral chambers 236, 238, each including the intermediate portion 270 shown in Figure 4, according to an exemplary embodiment. As shown in Figure 5, the peripheral chambers 236, 238 can include chamber walls 237, 239, each including a void 272 disposed between an outer wall surface 237a, 239a and an inner wall surface 237b, 239b, respectively. In some embodiments, the void 272 can extend the height of the chamber walls 233, 235, 237, 239, 241. For example, as shown in Figures 4 and 5, the void 272 can extend from the top surface 204 of the assay cartridge 200 to the bottom panel 255.
[0066]
[0074] Figure 6 is a schematic, enlarged top view of the peripheral chamber 240 with the intermediate portion 270 shown in Figure 4, according to an exemplary embodiment. As shown in Figure 6, the peripheral chamber 240 can include a chamber wall 241 with a partition 274 disposed between an outer wall surface 241a and an inner wall surface 241b. In some embodiments, the partition 274 can extend the height of the chamber walls 233, 235, 237, 239, 241. For example, as shown in Figures 4 and 6, the partition 274 can extend from the top surface 204 of the assay cartridge 200 to the bottom panel 255.
[0067]
[0075] As shown in FIG. 6 , the septum 274 can prevent or reduce the penetration of external moisture 280 into the enclosed reagent (e.g., lyophilized reagent 264), which can slow wetting of the enclosed reagent and / or extend the shelf life of detection of the reagent. In some embodiments, the septum 274 can be a moisture-wicking element configured to extend the shelf life of fluid interaction (e.g., exposure, reaction, contact, evaporation, dissolution, etc.) with the reagent (e.g., lyophilized reagents 260-264). For example, the septum 274 can include a desiccant, a desiccant, silica gel, calcium oxide, calcium chloride, zeolite, charcoal, or any combination thereof. In some embodiments, the septum 274 can be a dummy material configured to slow wetting of the reagent (e.g., lyophilized reagents 260-264) by the fluid. For example, the septum 274 can include a monohydrate, a disaccharide, a sugar, trehalose, sucrose, glucose, or any combination thereof. In some embodiments, a partition 274 can be disposed within the void 272. For example, the partition 274 can completely fill the void 272. In some embodiments, at least one partition 274 can be disposed within the void 272, effectively forming multiple voids.
[0068]
[0076] Exemplary Flow Diagram
[0077] Figure 7 illustrates a flow diagram 700 for detecting one or more properties of a fluid in a diagnostic assay system 100, according to an embodiment. It should be understood that not all steps in Figure 7 are required to practice the disclosure provided herein. Furthermore, some of the steps may be performed simultaneously, sequentially, and / or in an order different from that shown in Figure 7. Flow diagram 700 will be described with reference to Figures 1-6. However, flow diagram 700 is not limited to those exemplary embodiments.
[0069]
[0078] 4-6, the assay cartridge 200 may be formed to include a central chamber 230, one or more peripheral chambers 232, 234, 236, 238, 240, and a rotor 218. For example, the assay cartridge 200 may be formed by molding, thermoforming, or vacuum forming. In some embodiments, the one or more peripheral chambers 232, 234, 236, 238, 240 may include chamber walls 233, 235, 237, 239, 241 with a void 272 disposed between an outer wall surface 233a, 235a, 237a, 239a, 241a and an inner wall surface 233b, 235b, 237b, 239b, 241b, respectively. For example, as shown in Figure 5, the ambient chambers 236, 238 can include chamber walls 237, 239 each with a gap 272 disposed between an outer wall surface 237a, 239a and an inner wall surface 237b, 239b, respectively. In some embodiments, one or more of the chamber walls 233, 235, 237, 239, 241 can have a U-shape with an arcuate portion disposed between two legs coupled to the rotor 218. For example, as shown in Figures 4-6, the free ends of both legs of the U-shape can be coupled to the side wall surface 206 between the top surface 204 and the bottom panel 255.
[0070]
[0079] In step 704, as shown in the example of FIGS. 4-6, a septum 274 can be disposed within the void 272 of one or more of the peripheral chambers 232, 234, 236, 238, 240 of the assay cartridge 200 formed in step 702. For example, as shown in FIG. 6, the septum 274 can be disposed within the void 272 of the peripheral chamber 240 between the outer wall surface 241a and the inner wall surface 241b. In some embodiments, the septum 274 can be a moisture-absorbing element configured to extend the shelf life of fluid interaction with the reagents (e.g., the lyophilized reagents 260-264). For example, the septum 274 can include a desiccant, a dehumidifying material, silica gel, calcium oxide, calcium chloride, zeolite, charcoal, or any combination thereof. In some embodiments, the septum 274 can be a dummy material configured to retard wetting of the reagents (e.g., the lyophilized reagents 260-264) by the fluid. For example, the septum 274 can include a monohydrate, a disaccharide, a sugar, trehalose, sucrose, glucose, or any combination thereof.
[0071]
[0080] In step 706, as shown in the example of Figures 4-6, reagents (e.g., lyophilized reagents 260-264) can be placed in one or more of the peripheral chambers 232, 234, 236, 238, 240. For example, as shown in Figure 6, lyophilized reagent 264 can be placed in peripheral chamber 240 inside inner wall surface 241b.
[0072]
[0081] In step 708, reagents (e.g., lyophilized reagents 260-264) in one or more peripheral chambers 232, 234, 236, 238, 240 may interact with a fluid, as shown in the example of Figures 3 and 4. For example, as shown in Figures 3 and 4, a fluid may be disposed in central chamber 230 and / or one or more cartridge ports 218P and distributed to one or more peripheral chambers 232, 234, 236, 238, 240 via one or more channels 250, 251, 252, 253 and / or one or more channel ports 256, 257, 258, 259. In some embodiments, the fluid may interact with a second reagent (e.g., lyophilized reagents 260-264) in a second peripheral chamber 232, 234, 236, 238, 240. For example, as shown in FIGS. 3 and 4, fluid can interact with surrounding chambers 238 and 240 containing lyophilized reagent 263 via channels 253, 254 and channel port 259.
[0073]
[0082] 1-4, one or more properties of the fluid can be detected based on an interaction between the fluid and a reagent (e.g., lyophilized reagents 260-264) in one or more ambient chambers 232, 234, 236, 238, 240. For example, as shown in FIGS. 2 and 4, controller 114 of diagnostic assay system 100 can detect (e.g., chemically, optically, thermally, mechanically, magnetically, acoustically, etc.) an interaction between the fluid from syringe system 122 and one or more reagents (e.g., lyophilized reagents 260-264) in one or more ambient chambers 232, 234, 236, 238, 240 of assay cartridge 200, and identify one or more properties of the fluid (e.g., markers, DNA, cDNA, RNA, diseases, bacteria, viruses, etc.) based on the detected interaction. In some embodiments, the controller 114 may include one or more computer processors (e.g., a central processing unit (CPU), a microcontroller unit (MCU), etc.) and / or one or more sensors (e.g., chemical sensors, optical sensors, thermal sensors, mechanical sensors, magnetic sensors, acoustic sensors, etc.) or other dedicated, application-specific electronics or similar circuitry.
[0074]
[0083] In some embodiments, one or more properties of the fluid can be detected based on a first interaction of the fluid with a first reagent (e.g., lyophilized reagents 260-264) in one or more of the surrounding chambers 232, 234, 236, 238, 240 and a second interaction of the fluid with a second reagent (e.g., lyophilized reagents 260-264) in one or more of the surrounding chambers 232, 234, 236, 238, 240. For example, as shown in FIGS. 2, 4, and 5, the fluid can interact with a first lyophilized reagent 262 in the surrounding chamber 236 and a second lyophilized reagent 263 in the surrounding chamber 238. The controller 114 of the diagnostic assay system 100 can detect one or more properties of the fluid. The detected properties can be based at least in part on the results of either or both interactions.
[0075]
[0084] It is to be understood that the terms or phrases used herein are for the purpose of description, not of limitation, as they would be interpreted by one of ordinary skill in the art in light of the teachings herein.
[0076]
[0085] The following examples illustrate, but do not limit, embodiments of the present disclosure. Other suitable modifications and adaptations of the variety of conditions and parameters normally encountered in the art will be apparent to those skilled in the art and are within the spirit and scope of the present disclosure.
[0077]
[0086] While specific embodiments have been described above, it will be appreciated that embodiments may be practiced otherwise than as described, and this description is not intended to limit the scope of the claims.
[0078]
[0087] It is understood that the Detailed Description section, and not the Summary and Abstract sections, is intended to be used to interpret the claims. The Summary and Abstract sections may describe one or more, but not all, example embodiments as contemplated by the inventors, and therefore are not intended to limit the scope of the embodiments and appended claims in any way.
[0079]
[0088] The embodiments are described above using functional building blocks that illustrate the implementation of specified functions and the relationships between those functions. The boundaries of these functional building blocks are arbitrarily defined herein for the convenience of explanation. Alternative boundaries can be defined as long as the specified functions and the relationships between those functions are appropriately implemented.
[0080]
[0089] The foregoing description of specific embodiments sufficiently clarifies the general nature of the embodiments so that others, applying knowledge of the art, can readily modify and / or adapt such specific embodiments for various applications without undue experimentation and without departing from the general concept of the embodiments. Such adaptations and modifications are therefore intended to be within the meaning and range of equivalents of the disclosed embodiments, based on the teaching and guidance presented herein.
[0081]
[0090] The breadth and scope of embodiments should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following appended claims and their equivalents. [Explanation of symbols]
[0082] 100 Diagnostic Assay Systems 114 Controller 122 Syringe System 124 Linear Actuator 130 Rotary Actuator 200 Assay Cartridges
Claims
1. 1. A cartridge for detecting one or more properties of a fluid in a diagnostic assay system, comprising: a plurality of chambers; At least one chamber of the plurality of chambers a wall defining at least a portion of the chamber; the wall includes an intermediate portion disposed between an outer surface and an inner surface of the wall; the intermediate portion includes a void; A cartridge, the cartridge further includes a lyophilized reagent disposed within the wall; The fluid is disposed outside the wall. cartridge.
2. The cartridge of claim 1 , wherein the intermediate portion includes a moisture-wicking element configured to extend the shelf life of detection of the lyophilized reagent.
3. The cartridge of claim 2 , wherein the moisture absorbent element comprises a desiccant, a dehumidifying material, silica gel, calcium oxide, calcium chloride, zeolite, charcoal, or any combination thereof.
4. The cartridge of claim 1 , wherein the intermediate portion includes a dummy material configured to retard wetting of the lyophilized reagent by the fluid.
5. The cartridge of claim 4 , wherein the dummy material comprises a monohydrate, a disaccharide, a sugar, trehalose, sucrose, glucose, or any combination thereof.
6. The cartridge of claim 1 , wherein the intermediate portion is configured to reduce internal stresses and / or strains in the cartridge.
7. The cartridge of claim 1 , wherein the intermediate portion has a uniform width.
8. The cartridge of claim 7, wherein the width of the intermediate portion is between 10% and 90% of the width of the wall.
9. a subset of the plurality of chambers includes a wall; the wall corresponding to each chamber of the subset includes an intermediate portion disposed between an outer surface and an inner surface of the wall; The cartridge of claim 1 .
10. The cartridge of claim 9 , wherein each intermediate portion comprises a moisture absorbing element, a dummy material, an inert gas, or any combination thereof.
11. The cartridge of claim 1 , further comprising a rotor configured to rotate the plurality of chambers about an axis of rotation.
12. A cartridge as described in claim 1, further comprising a lid coupled to the plurality of chambers and configured to seal the plurality of chambers.
13. 13. The cartridge of claim 12, wherein the fluid is enclosed in one of the chambers that is external to the intermediate portion and external to the chamber that surrounds the lyophilized reagent.
14. 1. A diagnostic assay system comprising: a cartridge configured to receive a fluid, the cartridge including a plurality of chambers and a rotor, the rotor including a rotor port in fluid communication with at least one of the plurality of chambers; a syringe system coupled to the cartridge and configured to provide the fluid to the rotor port, the syringe system including a syringe barrel having a barrel port and a syringe plunger configured to inject and withdraw the fluid; a first actuator coupled to the cartridge and configured to rotate the rotor port into alignment with the barrel port; a second actuator coupled to the syringe system and configured to translate the syringe plunger; a controller coupled to the first actuator and the second actuator and configured to detect one or more properties of the fluid based on an interaction of the fluid with one or more lyophilized reagents; Including, at least one chamber of the plurality of chambers includes a wall defining at least a portion of the chamber; the wall includes an intermediate portion disposed between an outer surface and an inner surface of the wall; the intermediate portion includes a void; the cartridge further includes a lyophilized reagent disposed within the wall; The fluid is disposed outside the wall. Diagnostic assay systems.
15. 1. A method for detecting one or more properties of a fluid in a diagnostic assay system, comprising: forming a cartridge having a plurality of chambers and a rotor, a first chamber of the plurality of chambers including a wall defining at least a portion of the first chamber, the wall having an intermediate portion disposed between an outer surface and an inner surface of the wall, the intermediate portion including a void; disposing a lyophilized reagent inside the wall of the first chamber; disposing the fluid on an exterior side of the wall; allowing the fluid to interact with the lyophilized reagent in the first chamber; A method comprising:
16. 16. The method of claim 15, further comprising disposing a moisture-absorbing element, a dummy material, air, or an inert gas within the intermediate portion to extend the effective period for the fluid to interact with the freeze-dried reagent.
17. The method of claim 15 , further comprising detecting one or more properties of the fluid based on the interaction of the fluid with the lyophilized reagent.
18. 16. The method of claim 15, further comprising interacting the fluid with a second reagent in a second chamber of the plurality of chambers, the second chamber comprising a wall having a moisture-absorbing element, a dummy material, a void, or an inert gas disposed between an outer surface and an inner surface of the wall.
19. 20. The method of claim 18, further comprising detecting one or more properties of the fluid based on the interaction of the fluid with the lyophilized reagent and the second reagent.
20. The cartridge of claim 1 , wherein the middle portion contains an inert gas.
21. The inert gas is a noble gas, dinitrogen (N 2 ), carbon dioxide (CO 2 21. The cartridge of claim 20, comprising:
22. The method of claim 15 , wherein the intermediate portion comprises an inert gas.
23. The inert gas is a noble gas, dinitrogen (N 2 ), carbon dioxide (CO 2 23. The method of claim 22, comprising:
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