System for screening source plasma

Abstract

A plasma testing system includes a plasma collection bottle, having a body and an opening. The blood plasma bottle is configured to contain plasma, and a cartridge connectable to the opening of the bottle. The cartridge is configured to seal the opening of the bottle and includes plasma testing circuitry to test the plasma. The system further has a testing platform including at least one receptacle configured to receive the plasma collection bottle and the cartridge. The at least one receptacle has receiving circuitry in communication with the testing circuitry to receive a test result of the plasma test of the plasma.

Description

[0001] SYSTEM FOR SCREENING SOURCE PLASMA

[0002] CROSS REFERENCE TO RELATED APPLICATIONS

[0003] This Application claims priority from U.S. Provisional Patent Application No. 63 / 648,609, filed May 16, 2024, the contents of which are incorporated by reference herein in its entirety as if fully set forth.

[0004] FIELD

[0005] Illustrative embodiments of generally relate to blood processing and, more particularly, various embodiments relate to plasma testing.

[0006] BACKGROUND

[0007] Plasma donation relies on human donors from whom whole blood is extracted and then separated into individual components, including plasma. Before a donor can proceed with the plasma donation, they must undergo a screening process at the plasma donation center. If eligible, then donor can donate blood for producing plasma. The donated plasma, however, must undergo rigorous testing before it can be used.

[0008] SUMMARY OF VARIOUS EMBODIMENTS

[0009] In accordance with one embodiment, a plasma testing system includes a plasma collection bottle, having a body and an opening. The blood plasma bottle is configured to contain plasma, and a cartridge connectable to the opening of the bottle. The cartridge is configured to seal the opening of the bottle and includes plasma testing circuitry to test the plasma. The system further has a testing platform including at least one receptacle configured to receive the plasma collection bottle and the cartridge. The at least one receptacle has receiving circuitry in communication with the testing circuitry to receive a test result of the plasma test of the plasma.

[0010] In some embodiments, the plasma testing circuitry comprises a first and second circuitry in communication with a first bridge protein.

[0011] In some embodiments, the first bridge protein is in communication with a probe configured to couple with a specific target protein, the plasma testing circuitry is configured to output a first value after a target protein couples with the probe.

[0012] In some embodiments, the cartridge includes at least one selectively openable fluid pathway configured to communicate plasma from the body of the plasma collection bottle to the plasma testing circuitry when the fluid channel is open. In some embodiments, the cartridge includes a plurality of testing circuitries and a plurality of fluid channels, each fluid channel associated with one of the plurality of testing circuitries.

[0013] In some embodiments, a first testing circuitry of the plurality of testing circuitries tests for a first target protein and a second testing circuitry of the plurality of testing circuitries tests for a second target protein.

[0014] In some embodiments, the receptacle of the testing platform includes a penetrator for penetrating the cartridge to effect fluid communication of plasma contained in the plasma collection bottle to the testing circuitry of the cartridge.

[0015] In some embodiments, the penetrator comprises one or more of the following: a needle, a cannula, or a probe.

[0016] In some embodiments, the cartridge includes a slit for receiving the penetrator, the slit forming a fluid pathway when in communication with the penetrator, the fluid pathway configured to communicate plasma from the body of the plasma collection bottle to the plasma testing circuitry.

[0017] In some embodiments, the testing platform further comprises a plurality of receptacles for receiving a plurality of plasma collection bottles and cartridges.

[0018] In accordance with another embodiment, a plasma testing method includes collecting plasma in a plasma collection bottle. The plasma is extracted from at least one patient by an apheresis device. An opening of the plasma collection bottle is sealed with a cartridge, which includes plasma testing circuitry. The sealed plasma collection bottle is positioned relative to a receptacle of a testing platform to open at least a portion of the opening of the plasma collection bottle to fluidly communicate the plasma with the plasma testing circuitry. The testing platform includes receiving circuitry in communication with the testing circuitry to receive a test result of the plasma test from the plasma testing circuitry.

[0019] In some embodiments, the plasma testing circuitry comprises a first and second circuitry in communication with a first bridge protein.

[0020] In some embodiments, the first bridge protein is in communication with a probe configured to couple with a specific target protein, the plasma testing circuitry is configured to output a first value after a target protein couples with the probe.

[0021] In some embodiments, the method further includes fluidly communicating, via at least one fluid pathway, the plasma from the body of the plasma collection bottle to the plasma testing circuitry. In some embodiments, the cartridge includes a plurality of testing circuitries and a plurality of fluid channels, each fluid channel associated with one of the plurality of testing circuitries.

[0022] In some embodiments, the method further includes testing for a first target protein by a first testing circuitry of the plurality of testing circuitries tests and testing for a second target protein by a second testing circuitry of the plurality of testing circuitries.

[0023] In some embodiments, the method further includes penetrating the cartridge, by a penetrator of the receptacle of the testing platform, to effect fluid communication of plasma contained in the plasma collection bottle to the testing circuitry of the cartridge.

[0024] In some embodiments, the penetrator comprises one or more of the following: a needle, a cannula, or a probe.

[0025] In some embodiments, the cartridge includes a selectively openable slit for receiving the penetrator.

[0026] In some embodiments, the testing platform further comprises a plurality of receptacles for receiving a plurality of plasma collection bottles and cartridges.

[0027] Illustrative embodiments are implemented as a computer program product having a computer usable medium with computer readable program code thereon. The computer readable code may be read and utilized by a computer system in accordance with conventional processes.

[0028] BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Those skilled in the art should more fully appreciate advantages of various embodiments from the following “Description of Illustrative Embodiments,” discussed with reference to the drawings summarized immediately below.

[0030] Figure 1 schematically shows a plasma production and testing system in accordance with illustrative embodiments.

[0031] Figure 2 schematically shows an exemplary perspective view of a blood / plasma processing system in accordance with illustrative embodiments.

[0032] Figure 3 schematically shows an exemplary plan view of the blood / plasma processing system of Figure 2.

[0033] Figure 4 schematically shows an example of a disposable set installed within the blood / plasma processing system of Figure 2 in accordance with illustrative embodiments.

[0034] Figure 5 schematically shows an exemplary plasma collection bottle in accordance with illustrative embodiments.

[0035] Figure 6 schematically shows an exemplary consumable cartridge configured to test plasma in accordance with illustrative embodiments. Figure 7 schematically shows the exemplary cartridge of Figure 6 coupled with the exemplary plasma collection bottle of Figure 5 in accordance with various embodiments.

[0036] Figure 8 schematically shows an exemplary electromechanical interface testing platform for a plurality of plasma bottles in accordance with illustrative embodiments.

[0037] Figure 9 shows a flow chart of an exemplary method of testing plasma in accordance with illustrative embodiments.

[0038] DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

[0039] Extensive infrastructure has been developed to collect human plasma specifically for biopharmaceutical production. Several companies operate networks of collection centers, testing facilities, fractionation sites, and manufacturing plants — primarily in the United States. These companies typically specialize in producing biopharmaceuticals such as intravenous immunoglobulin (IVIG), albumin, plasma clotting factors, and other plasma-derived therapies.

[0040] Plasma is collected in high volumes — often greater than 50 million liters per year. Global regulatory bodies mandate that plasma used to produce biopharmaceuticals be screened for viruses and other pathogens (HIV, HAV, HBV, etc.). In addition, each center may be interested in the protein levels of donors to better optimize their production flow. To those ends, companies in this space typically use a network of remote collection centers with centralized testing facilities. Accordingly, after a plasma collection, a sample often is taken from each bottle of plasma and sent to a separate testing facility. The units of plasma are held in quarantine in until results are received, and each unit is cleared for production.

[0041] This distributed network of collection centers and test facilities presents significant inefficiencies and error risk. In contrast, various embodiments include local testing of plasma at the collection facility. For example, one system may extract a small sample directly from the collection bottle, conduct some or all necessary testing in a closed system, immediately assign a disposition to the bottle, and communicate necessary results to the center’s information system.

[0042] Although described in further detail below, in illustrative embodiments, plasma is collected by an apheresis device and stored in a plasma collection bottle. The plasma collection bottle is sealed by a cartridge that is removably (or not removable) and sealingly attached to the opening of the plasma collection bottle. To test locally the cartridge includes in situ circuitry that is configured to test the plasma similarly to the way described above. To that end, the plasma collection bottle / cartridge is configured to be placed or positioned relative to (on or in) a receptacle of a testing platform (e.g., electromechanical, or simply a mechanical interface) to effect and facilitate testing of a sample of the plasma. Figure 1 schematically shows an exemplary plasma testing system in accordance with illustrative embodiments. Although various components are shown schematically in the exemplary plasma testing system of Figure 1, it is understood that not all components may be shown, and the components depicted are for exemplary purposes. Further, the components shown in Figure 1 are described generally with respect to Figure 1 and will be described in further detail below.

[0043] Accordingly, Figure 1 schematically shows a system for producing and testing plasma. To that end, the system includes an apheresis device 100 is utilized to collect plasma from a patient / donor. The plasma extracted from the apheresis device 100 is stored in a plasma collection bottle 500 (e.g., a one liter bottle). In the system shown in Figure 1, after filled sufficiently, the bottle 500 is sealed with a cap, in the form of a cartridge 600, that is removably and sealingly coupled to an opening of the plasma collection bottle 500. The system also includes a testing platform 800, which may be in communication (wired / wireless) with a computing device 1000 (e.g., a desktop computer, laptop, etc.). The testing platform 800 has a plurality of receptacles that each receive one bottle 500. Details of the interaction of these components are discussed below.

[0044] Figures 2-4 detail some components making up the plasma collection and associated devices as configured in illustrative embodiments and described above with regard to Figure 1.

[0045] Generally speaking, apheresis devices 100 are medical devices designed to selectively remove specific components from a person's blood while returning the remaining blood components back to the individual. As discussed below in greater detail with regard to Figures 2- 4, the apheresis device 100 has several primary components. First, it incorporates a system for accessing the individual's blood, often through the insertion of intravenous lines or catheters. The device then uses various methods, such as centrifugation or filtration, to separate the blood components based on their physical or chemical properties. The desired components are collected into specialized containers or bags for further processing or use. Throughout the process, apheresis devices 100 incorporate monitoring systems and control mechanisms to ensure accuracy and safety. These systems may include sensors, pumps, and software interfaces that regulate flow rates, volumes, and other parameters.

[0046] Safety features are a crucial aspect of apheresis devices 100. They can include alarms for pressure or flow irregularities, air detection systems, and safety interlocks to protect the donor, patient, and the operator. Apheresis procedures have a wide range of therapeutic applications, including manufacturing into therapies, collecting blood components for transfusion, removing excess or abnormal substances from the blood, and treating specific medical conditions. Plateletpheresis, plasmapheresis, and leukapheresis are examples of therapeutic apheresis procedures.

[0047] In medical settings, such as blood or plasma centers, hospitals, and specialized clinics, as well in mobile settings, apheresis devices 100 are employed by trained professionals to perform these procedures. The devices supply the necessary technology and control to efficiently and safely separate blood components. Their use is critical for addressing various therapeutic needs and ensuring the well-being of patients undergoing apheresis procedures.

[0048] Figure 2 schematically shows an exemplary perspective view of a blood / plasma processing system in accordance with illustrative embodiments. Figure 3 schematically shows an exemplary plan view of the blood / plasma processing system of Figure 2. Figure 4 schematically shows an exemplary of a disposable set installed within the blood / plasma processing system of Figure 2 in accordance with illustrative embodiments.

[0049] As shown, the apheresis device 100 includes a cabinet 110 that houses the main components of the apheresis device 100 (e.g., the non-disposable components). Within the cabinet 110, the apheresis device 100 may include a first / blood pump 232 that draws whole blood from a subject, and a second / anticoagulant pump 234 that pumps anticoagulant through the apheresis device 100 and into the drawn whole blood. Additionally, the apheresis device 100 may include a number of valves that may be opened and / or closed to control the fluid flow through the apheresis device 100. For example, the apheresis device 100 may include a donor valve 120 that may open and close to selectively prevent and allow fluid flow through a donor line 218 (e.g., an inlet line shown in Figure 4), and a plasma valve 130 that selectively prevents and allows fluid flow through an outlet / plasma line 222 (Figure 4). Some embodiments may also include a saline valve 135 that selectively prevents and allows saline to flow through a saline line 223.

[0050] To facilitate the connection and installation of a disposable set and to support the corresponding fluid containers, the apheresis device 100 may include an anticoagulant pole 150 on which the anticoagulant solution container 210 (Figure 4) may be hung, and a saline pole 160 on which a saline solution container 217 (Figure 4) may be hung (e.g., if the procedure being performed requires the use of saline). Additionally, in some applications, it may be necessary and / or desirable to filter the whole blood drawn from the subject for processing. To that end, the apheresis device 100 may include blood filter holder 170 in which the blood filter (located on the disposable set) may be placed.

[0051] As discussed in greater detail below, apheresis systems 100 in accordance with illustrative embodiments withdraw whole blood from a subject (aka “donor”) through a venous access device 206 (Figure 4) using the blood pump 232. As the apheresis device 100 withdraws the whole blood from the subject, the whole blood enters a blood component separation device 214, such as a Latham type centrifuge (other type of separation chambers and devices may be used, such as, without limitation, an integral blow-molded centrifuge bowl, as described in U.S. Pat. Nos. 4,983,158 and 4,943,273). The blood component separation device 214 separates the whole blood into its constituent components (e.g., red blood cells, white blood cell, plasma, and platelets). Accordingly, to facilitate operation of the separation device 214, the apheresis device 100 may also include a well 180 in which the separation device 214 may be placed and in which the separation device 214 rotates (e.g., to generate the centrifugal forces required to separate the whole blood).

[0052] To allow the user / technician to monitor the system operation and control / set the various parameters of the procedure, the apheresis device 100 may include a user interface 190 (e.g., a touch screen device) that displays the operation parameters, any alarm messages, and buttons which the user / technician may depress to control the various parameters. Additional components of the apheresis device 100 are discussed in greater detail below (e.g., in relation to the system operation).

[0053] Figure 4 schematically shows, as a block diagram, the apheresis device 100 and a disposable collection set 200 (with an inlet disposable set 200A and an outlet disposable set 200B) that may be loaded onto / into the apheresis device 100, in accordance with the illustrative embodiments. The collection set 200 includes a venous access device 206 (e.g., a phlebotomy needle) for withdrawing blood from a donor's arm 208, a container of anti-coagulant 210, a centrifugation bowl 214 (e.g., a blood component separation device), a saline container 217, and a final plasma collection bag 216. The blood / inlet line 218 couples the venous access device 206 to an inlet port 220 of the bowl 214, the plasma / outlet line 222 couples an outlet port 224 of the bowl 214 to the plasma collection bag 216, and a saline line 223 connects the outlet port 224 of the bowl 214 to the saline container 217. An anticoagulant line 225 connects the anti-coagulant container 210 to the inlet line 218. In addition to the components mentioned above and as shown in Figure 4, the apheresis device 100 includes a controller 226, a motor 228, and a centrifuge chuck 230. The controller 226 is operably coupled to the two pumps 232 and 234, and to the motor 228, which, in turn, drives the chuck 230. The controller 226 may be operably coupled to and in communication with the user interface 190.

[0054] In operation, the disposable collection set 200 (e.g., the inlet disposable set 200A and the outlet disposable set 200B) may be loaded onto / into the apheresis device 100 prior to blood processing. In particular, the blood / inlet line 218 is routed through the blood / first pump 232 and the anticoagulant line 225 from the anti -coagulant container 210 is routed through the anticoagulant / second pump 234. The centrifugation bowl 214 may then be securely loaded into the chuck 230. After the bowl 214 is secured in place, the technician may install the outlet disposable set 200B. For example, the technician may connect a bowl connector 300 to the outlet 224 of the bowl 214, install the plasma container 216 into the weight senor 195, run the saline line 223 through valve 135, and run the plasma / outlet line 222 through valve 130 and the line sensor 185. After the disposable set 200 is installed and the anticoagulant and saline containers 210 / 217 are connected, the apheresis device 100 is ready to begin blood processing.

[0055] Apheresis devices 100 are utilized with donors or patients in a controlled and monitored environment, ensuring the safety and well-being of the individual undergoing the procedure. The process typically begins with careful donor or patient preparation and assessment to determine their eligibility and suitability for apheresis.

[0056] Before the procedure, the donor’s or patient’s vital signs, medical history, and relevant laboratory tests are reviewed to ensure that they meet the specific criteria for apheresis. The donor or patient is informed about the procedure, its purpose, and any potential risks or side effects. Informed consent is obtained to ensure that the donor or patient understands the nature of the procedure and provides their agreement to proceed.

[0057] After the donor or patient is prepared, an appropriate blood access point is established to facilitate the collection and return of blood. This may involve the insertion of one or more intravenous lines or catheters, depending on the specific requirements of the apheresis procedure. The access points are carefully chosen to minimize discomfort and ensure adequate blood flow during the process.

[0058] Next, the apheresis device 100 is set up and configured based on the prescribed parameters for the procedure. This includes programming the device with the desired settings, such as flow rates, separation protocols, and collection volumes, which are tailored to the individual patient's needs.

[0059] During the procedure, the apheresis device 100 carefully extracts blood from the donor or patient through the established blood access point. The blood flows through the device, where, as noted with regard to Figures 2-4, it undergoes the separation process, either by centrifugation or filtration. The targeted blood component, such as platelets, plasma (in preferred embodiments), or white blood cells, is selectively collected while the remaining blood components are returned to the patient.

[0060] Throughout the procedure, the patient's vital signs, including blood pressure, heart rate, and oxygen saturation, are closely monitored to ensure their safety and well-being. The apheresis device's monitoring systems continuously assess critical parameters, such as flow rates, pressures, and component levels, allowing operators to make real-time adjustments if necessary. Once the desired amount of the targeted component is collected or the prescribed procedure time is reached, the apheresis device 100 completes its portion of the process. The donor’s or patient's blood access points are carefully removed, and appropriate post-procedure care and monitoring are provided to ensure their comfort and recovery.

[0061] The collected blood components often undergo further processing, testing, and preparation as required for their intended therapeutic use. This can involve additional steps such as component labeling, manufacturing, storage, and compatibility testing to ensure their safety and effectiveness when administered to patients.

[0062] Accordingly, after collected, the plasma is tested to ensure safety of the plasma for use in a patient needing a plasma transfusion. In various embodiments, the collection of the plasma from the apheresis device 100 is stored in a plasma collection bottle.

[0063] Figure 5 schematically shows more details of an exemplary plasma collection bottle 500 in accordance with illustrative embodiments. The plasma collection bottle 500 includes a body 510 defining a container for containing plasma collected from a donor. The plasma collection bottle 500 has a rim that terminates at an opening 520, which preferably is configured to receive a cap / lid or other component to seal the plasma collection bottle 500 to prevent plasma from leaking from the plasma collection bottle 500 or contaminants from entering the plasma. Plasma may be collected into these bottles via an apheresis procedure with systems like the PCS2® or NexSys PCS®, distributed by Haemonetics Corporation, and / or as described above.

[0064] While a standard cap may be used to seal the bottle 500, illustrative embodiments use the prior noted disposable test cartridge, which is shown in more detail in Figure 6. Specifically, Figure 6 schematically shows an exemplary consumable cartridge 600 configured to test plasma in accordance with illustrative embodiments. The cartridge 600 includes a first face 610, which may be top face and a second face 620, which may be a bottom face. Although not shown, the bottom face may include a component, such as a snap fitting, threads, or the like, to secure it to the opening 520 of the plasma collection bottle 500, sealing the opening 520, and effectively the plasma collection bottle 500.

[0065] Additionally, the first face 610 may include fluid channels 630 and one or more fluid collection portions 640. The fluid channels 630 may be in fluid communication with a selectively openable, but normally closed, slit (not shown) in the cartridge 600 to effect fluid flow of plasma contained in the body 510 of the plasma collection bottle 500. Accordingly, when unsealed, plasma may flow from the plasma collection bottle 500, through the open slit acting as a fluid pathway to the fluid channels 630. From there, the fluid / liquid (i.e., plasma) flows from the fluid channels 630 to the fluid collection portions 640, where testing of the plasma sample may occur. Each fluid collection portion may have testing circuitry testing the same or different aspects of the plasma (discussed below).

[0066] Accordingly, the cartridge 600 includes various microfluidic mechanisms, biosensors and / or interfaces that would be required to execute all required / necessary testing. Moreover, after collection, the plasma filled plasma collection bottle 500 may be transported to an on-site testing facility. Accordingly, the cartridge 600 is attached to the top of the plasma collection bottle 500 forming a combined bottle.

[0067] Various embodiments may test for specific biomarkers — such as proteins, enzymes, and electrolytes — that can indicate conditions like liver disease, kidney dysfunction, infections, or clotting disorders. Plasma tests may include the complete blood count (CBC), blood chemistry panels, and coagulation tests, each of which offering different insights into the body’s systems. Abnormal levels of certain substances in the plasma can signal health issues that may require further testing or treatment and may render the plasma unusable for donation to a patient.

[0068] In various embodiments, testing may use a “lab on a chip” technique, where the testing sensors and circuitry may be resident on a chip themselves. In the example shown in Figure 6, the cartridge 600 may include components to perform testing on the cartridge, or within the cartridge.

[0069] For example, the cartridge 600 may include testing components (e.g., integrated circuits) configured with molecular electronics sensors that use individual molecules and / or proteins to detect and measure biological or chemical interactions. Unlike traditional sensors that rely on bulk materials, these sensors may be configured to operate at the single-molecule level, allowing for precise and sensitive detection. They are built on semiconductor chips and use specially engineered molecular wires that connect to nanoelectrodes, forming a circuit that can directly read out molecular activity as electrical signals.

[0070] In illustrative embodiments, each sensor is programmed by attaching a bridge protein — such as DNA, an antibody, or an enzyme — to the molecular wire. The bridge protein thus is appropriately named as it acts as a “bridge” between two portions of a circuit. For example, it can act as an effective resistor in the circuit between the two circuit portions. The bridge protein has an associated probe molecule configured to secure with a prescribed target molecule. Accordingly, when a target molecule (e.g., target protein) interacts with the probe, it causes a change in bridge molecule, which directly changes the electrical current flowing between the circuit portions. This current change is recorded in real time, providing a signal that reflects the molecular interaction. Because the sensor operates at such a small scale, it can detect extremely small changes, making it effective for applications like disease diagnostics, DNA sequencing, polymerase, etc. When a target protein interacts with the probe, resistance between the circuit portions decreases, increasing the current. Accordingly, the testing circuitry may register a current at a first value (on) when the target protein is coupled with the probe, while registering a second value (off) when the target protein does not couple with the probe (e.g., no interaction occurs with the probe).

[0071] Figure 7 schematically shows the exemplary cartridge 600 of Figure 6 coupled with the exemplary plasma collection bottle of Figure 5 to form a combined collection bottle 700 in accordance with various embodiments. As noted above, the combined collection bottle 700 includes a seal capable of being pierced to allow the test system to extract a small volume of plasma for testing as mentioned above. For example, the above noted slit (not shown) may be pierced by a penetrator to effect flow of the small volume of plasma for testing. In other embodiments, the cartridge 600 has a thin portion that can be pierced to open a fluid pathway to the testing circuitry and related fluid channels.

[0072] Figure 8 schematically shows an exemplary electromechanical interface testing platform 800 for a plurality of plasma collection bottles 700 sealed by cartridges 600 in accordance with illustrative embodiments. As shown in Figure 8, the testing platform 800 includes a base 810 that houses one or more receptacles 820.

[0073] Each receptacle 820 forms area volume to receive and position the combined collection bottle 700 for testing. Each receptacle 820 may also include a penetrator or the like to penetrate the cartridge 600 to open the prior noted fluid pathway to the testing surface of the cartridge 600. As such, plasma from the interior of the combined collection bottle 700 may flow into one or more of the channels 630 of the cartridge 600, and ultimately to one or more of the fluid collection portions 640. Finally, at the testing circuitry of the cartridge 600, testing circuitry may test the plasma for any of a variety of different issues as described above. Among other things, the penetrator may include one or more of a needle, a cannula, or a probe. Other embodiments may use other coupling or opening techniques to open the fluid pathway in the cartridge 600.

[0074] Figure 9 shows a flow chart of an exemplary method of testing plasma in accordance with illustrative embodiments. The method begins at step 900, which extracts blood from a patient via the apheresis device, separates the plasma, and stores the plasma in the plasma collection bottle 500. After collecting a sufficient amount of plasma, step 902 seals the opening 520 of the plasma collection bottle 500 with the cartridge 600. For example, the cartridge 600 is attached to the opening 520 of the plasma collection bottle 500 (e.g., by snapping on, twisting on, screwing on, etc.). Step 904 then positions the sealed combined plasma collection bottle 700 on or in one of the receptacles 820 of the testing platform 800. This causes the penetrator to open the fluid pathway through the cartridge 600, releasing the plasma into its receptacle. To that end, in various embodiments, the combined plasma collection bottle 700 may be rotated to an “upside down” position and placed in the receptacle 820. Preferably, the cartridge is registered with the shape and size of the receptacle, effectively registering the penetrator with the slit or other bottle access means via the cartridge.

[0075] In various embodiments, the testing platform may also include receiving circuitry in communication with the testing circuitry of the cartridge 600 to receive the test result from the plasma testing circuitry. The receiving circuitry in turn then may then communicate with an external logic device (e.g., a computer device) that analyzes the test results from the testing circuitry and determine whether the tested plasma is usable. Other embodiments may have onboard logic (i.e., a part of the platform 800) configured to make the determination of whether the plasma is usable or not. In short, the testing circuitry produces one or more values that logic (onboard or offboard) uses to determine whether the plasma is usable. These components may communicate via direct hard connection, wireless connections, or both.

[0076] In various embodiments, the cartridge 600 may communicate test results directly to a computer device or provide results independently of the testing platform. For example, the testing platform may not include any circuitry to receive test results.

[0077] Accordingly, as a lab-on-a chip or similarly enabled technology, the method described above involves the precise control and manipulation of minute fluid volumes through networks of channels and chambers etched or molded into a substrate in the cartridge (e.g., nearest the top of the cartridge) and on the integrated circuits. These substrates may be formed from one or more of a polymer (e.g., polydimethylsiloxane), silicone, and / or glass. The microchannels, typically ranging from tens to hundreds of micrometers in width, enable the controlled movement and interaction of plasma with various reagents and detection elements on the chip.

[0078] In the context of plasma testing, the cartridge with its one or more ab-on-a-chip device(s) perform comprehensive analyses rapidly and accurately. In various embodiments, when a plasma sample is introduced into the integrated circuit, it is guided through a series of microfluidic channels where it undergoes various preparatory steps. These steps may include fdtration to remove cells and debris, mixing with reagents to initiate specific biochemical reactions, and incubation to allow these reactions to proceed. The chip can also incorporate elements like microvalves and micropumps to precisely control fluid movement and timing, ensuring that each step occurs in the correct sequence.

[0079] While the above embodiments discuss a current based sensor, other embodiments may use those and / or other types of sensors. For example, various embodiments may use one or more of optical sensors, electrochemical detectors, or mass spectrometers, depending on the specific application and the type of analysis required. For plasma testing, optical detection methods may prove useful. These may involve the use of fluorescent or colorimetric indicators that produce a measurable signal when they interact with specific biomarkers present in the plasma. The intensity or wavelength of the emitted light can then be detected and quantified by on-chip sensors.

[0080] In various embodiments, a capability of tracking each bottle through bar codes, RFID tags or other techniques may be utilized. After testing, the test results can be saved to a plasma collection center’s information system and / or linked directly to the specific bottle. In various embodiments, a donor may be notified a specific bottle with a failed test, or the bottle may be marked (e.g., permanently) to ensure that it is not used.

[0081] Various embodiments may be implemented at least in part in any conventional computer programming language. For example, some embodiments may be implemented in a procedural programming language (e.g., “C”), or in an object-oriented programming language (e.g., “C++”). Other embodiments may be implemented as a pre-configured, stand-alone hardware element and / or as preprogrammed hardware elements (e.g., application specific integrated circuits, FPGAs, and digital signal processors), or other related components.

[0082] In an alternative embodiment, the disclosed apparatus and methods (e.g., see the various flow charts described above) may be implemented as a computer program product for use with a computer system. Such implementation may include a series of computer instructions fixed either on a tangible, non-transitory medium, such as a computer readable medium (e.g., a diskette, CD-ROM, ROM, solid state drive, or fixed disk). The series of computer instructions can embody all or part of the functionality previously described herein with respect to the system.

[0083] Those skilled in the art should appreciate that such computer instructions can be written in a number of programming languages for use with many computer architectures or operating systems. Furthermore, such instructions may be stored in any memory device, such as semiconductor, magnetic, optical, or other memory devices, and may be transmitted using any communications technology, such as optical, infrared, microwave, or other transmission technologies.

[0084] Among other ways, such a computer program product may be distributed as a removable medium with accompanying printed or electronic documentation (e.g., shrink wrapped software), preloaded with a computer system (e.g., on system ROM or fixed disk), or distributed from a server or electronic bulletin board over the network (e.g., the Internet or World Wide Web). In fact, some embodiments may be implemented in a software-as-a-service model (“SAAS”) or cloud computing model. Of course, some embodiments may be implemented as a combination of both software (e.g., a computer program product) and hardware. Still other embodiments are implemented as entirely hardware, or entirely software.

[0085] The embodiments described above are intended to be merely exemplary; numerous variations and modifications will be apparent to those skilled in the art. Such variations and modifications are intended to be within the scope of the present application as defined by any of the appended claims.

Claims

What is claimed is:

1. A plasma testing system, comprising: a plasma collection bottle, having a body and an opening, the blood plasma bottle configured to contain plasma; a cartridge connectable to the opening of the bottle, the cartridge configured to seal the opening of the bottle, wherein the cartridge includes plasma testing circuitry to test the plasma; and a testing platform including at least one receptacle configured to receive the plasma collection bottle and the cartridge, the at least one receptacle including receiving circuitry in communication with the testing circuitry to receive a test result of the plasma test of the plasma.

2. The plasma testing system of claim 1, wherein the plasma testing circuitry comprises a first and second circuitry in communication with a first bridge protein.

3. The plasma testing system of claim 2, wherein the first bridge protein is in communication with a probe configured to couple with a specific target protein, the plasma testing circuitry is configured to output a first value after a target protein couples with the probe.

4. The plasma testing system of claim 1, wherein the cartridge includes at least one selectively openable fluid pathway configured to communicate plasma from the body of the plasma collection bottle to the plasma testing circuitry when the fluid channel is open.

5. The plasma testing system of claim 4, wherein the cartridge includes a plurality of testing circuitries and a plurality of fluid channels, each fluid channel associated with one of the plurality of testing circuitries.

6. The plasma testing system of claim 5, wherein a first testing circuitry of the plurality of testing circuitries tests for a first target protein and a second testing circuitry of the plurality of testing circuitries tests for a second target protein.

7. The plasma testing system of claim 1, wherein the receptacle of the testing platform includes a penetrator for penetrating the cartridge to effect fluid communication of plasma contained in the plasma collection bottle to the testing circuitry of the cartridge.

8. The plasma testing system of claim 7, wherein the penetrator comprises one or more of the following: a needle, a cannula, or a probe.

9. The plasma testing system of claim 7, wherein the cartridge includes a slit for receiving the penetrator, the slit forming a fluid pathway when in communication with the penetrator, the fluid pathway configured to communicate plasma from the body of the plasma collection bottle to the plasma testing circuitry.

10. The plasma testing system of claim 1, wherein the testing platform further comprises a plurality of receptacles for receiving a plurality of plasma collection bottles and cartridges.

11. A plasma testing method, comprising: collecting plasma in a plasma collection bottle, the plasma extracted from at least one patient by an apheresis device; sealing an opening of the plasma collection bottle with a cartridge, the cartridge comprising plasma testing circuitry; and positioning the sealed plasma collection bottle relative to a receptacle of a testing platform to open at least a portion of the opening of the plasma collection bottle to fluidly communicate the plasma with the plasma testing circuitry, wherein the testing platform includes receiving circuitry in communication with the testing circuitry to receive a test result of the plasma test from the plasma testing circuitry.

12. The method of claim 10, wherein the plasma testing circuitry comprises a first and second circuitry in communication with a first bridge protein.

13. The method of claim 12, wherein the first bridge protein is in communication with a probe configured to couple with a specific target protein, the plasma testing circuitry is configured to output a first value after a target protein couples with the probe.

14. The method of claim 13, further comprising fluidly communicating, via at least one fluid pathway, the plasma from the body of the plasma collection bottle to the plasma testing circuitry.

15. The method of claim 14, wherein the cartridge includes a plurality of testing circuitries and a plurality of fluid channels, each fluid channel associated with one of the plurality of testing circuitries.

16. The method of claim 15, further comprising testing for a first target protein by a first testing circuitry of the plurality of testing circuitries tests and testing for a second target protein by a second testing circuitry of the plurality of testing circuitries.

17. The method of claim 10, further comprising penetrating the cartridge, by a penetrator of the receptacle of the testing platform, to effect fluid communication of plasma contained in the plasma collection bottle to the testing circuitry of the cartridge.

18. The method of claim 17, wherein the penetrator comprises one or more of the following: a needle, a cannula, or a probe.

19. The method of claim 17, wherein the cartridge includes a selectively openable slit for receiving the penetrator.

20. The method of claim 10, wherein the testing platform further comprises a plurality of receptacles for receiving a plurality of plasma collection bottles and cartridges.

Images