INTEGRATED POINT-OF-CARE CARTRIDGE ASSAY SYSTEM

• US 20190317115A1
• Filed: 04/11/2019
• Published: 10/17/2019
• Est. Priority Date: 04/11/2018
• Status: Abandoned Application

• Current Assignee: Vitameter Inc.
• Original Assignee: Vitameter Inc.
• Inventors: MacLean, James Laughlin, Brereton, Calvin James, Udayakumar, Nirushan Darren, Tan, Lynnea Lurline Yee Lin, Bhatt, Nishi Pavankumar
• Application Number:
  US16/381,721
• Publication Number:
  US 20190317115A1
• Time in Patent Office: Days
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/065 sliding valves
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/52 Containers specially adapted for storing or dispensing a reagent B01L3/02 takes precedence; containers for medical or pharmaceutical purposes A61J1/00; containers in general B65D; storing or dispensing test elements G01N33/4875; automated reagent dispensing G01N35/1002
• CPC Class Codes: G01N 2035/00108 Test strips, e.g. paper
• CPC Class Codes: G01N 2035/00891 Displaying information to the operator
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 35/00029 provided with flat sample substrates, e.g. slides G01N35/028 takes precedence
• CPC Class Codes: G01N 35/00722 Communications; Identification

Abstract

A method and system for user-friendly point of care assay is described. The cartridge utilizes a lateral flow assay, buffer chambers and capillary sample collection. The sample is first collected by the capillary tube attached to the cartridge. The cartridge is then actuated, drawing the sample into the lateral flow strip and introducing a buffer liquid into the system thereby automatically performing the assay. An electronic reader may be used to measure the results of the assay.

Claims

1. A test cartridge that allows for an automated assay of various analytes in a sample, wherein the test cartridge comprises:

a capillary assembly to receive, store and release the sample;

a buffer capsule for storing and releasing a buffer liquid;

a buffer membrane to receive the buffer liquid during the assay;

a test strip that is coupled to the buffer membrane and adapted to perform the assay after receiving the sample and the buffer liquid;

a test strip holder adapted to hold the test strip and the buffer membrane and move towards the capillary assembly and the buffer membrane to provide the sample to the test strip and the buffer liquid to the buffer membrane when the assay is performed; and

an enclosure for providing a housing for the test cartridge.

2. The test cartridge of claim 1, wherein the test strip holder is adapted to move from a pre-actuation position to a post-actuation position, wherein in the pre-actuation position the test strip and the buffer membrane are spaced apart from the capillary assembly and the buffer capsule, respectively, and in the post-actuation position the test strip is brought into contact with the capillary assembly to receive the sample, the buffer membrane is brought into contact with the buffer capsule to receive the buffer liquid which is then transferred to the test strip and the test strip performs the assay.

3. The test cartridge of claim 1, further comprising a sliding rail system made of slots formed in one surface of the test strip holder and pegs formed in an opposing surface of the enclosure and the test strip holder is adapted to move along the sliding rail system.

4. The test cartridge of claim 3, wherein the enclosure comprises an aperture opposite a bottom end of the test strip holder for receiving a force to move the test strip holder from the pre-actuation position to the post-actuation position.

5. The test cartridge of claim 1, wherein the capillary assembly is located at an upper corner of the enclosure and comprises:

an outer facing end having a first aperture open to an exterior of the enclosure;

an inner facing end having a second aperture open to an interior of the enclosure; and

a capillary tube between the outer facing end and the inner facing end, the capillary tube drawing the sample into the capillary assembly using capillary forces during use.

6. The test cartridge of claim 1, wherein the test strip comprises:

a backing card for providing support for membranes of the test strip;

a reaction membrane disposed on the backing card, the reaction membrane having reaction zones including a control zone for providing control measurements and at least one assay reaction zone for reacting with at least one analyte of interest;

a conjugate pad overlaid on a distal portion of the reaction membrane, the conjugate pad containing chemicals for performing the assay; and

a sample pad overlaid on a distal portion of the conjugate pad and wrapped around a back surface of the backing card and having a rounded end at a distal portion of the test strip, the sample pad having a filter membrane disposed adjacent the rounded end for receiving the sample and having a buffer entrance area disposed near the back surface of the backing card for receiving the buffer liquid.

7. The test cartridge of claim 6, wherein the chemicals of the conjugate pad comprise at least one of buffers, surfactants, salts, antibodies and labelling agents.

8. The test cartridge of claim 6, wherein when the test strip holder is moved to the post-actuation position, the rounded end of the sample pad is moved to the inner facing end of the capillary assembly to receive the sample from the capillary tube.

9. The test cartridge of claim 6, wherein the buffer membrane comprises:

a buffer intake area to receive the buffer liquid from the buffer capsule;

a U-shaped bottom region downstream of the buffer intake area where the buffer liquid pools as the buffer liquid drawn from the buffer capsule;

a junction region downstream of the bottom region and adjacent to the test strip; and

an exit region comprising an arm adjacent to and downstream of the junction region, the exit region overlapping with the buffer entrance area of the test strip to provide the buffer liquid thereto.

10. The test cartridge of claim 9, wherein the test strip holder comprises a protrusion that is moved into an end of the buffer capsule to release the buffer liquid to the buffer membrane when the test strip holder is moved to the post-actuation position.

11. The test cartridge of claim 9, wherein the buffer membrane comprises an arm portion that is fluidly coupled to the test strip to provide the buffer liquid thereto, the arm portion having a size, shape and material that are selected to provide a desired flow rate to delay the arrival of the buffer liquid into the test strip.

12. The test cartridge of claim 6, wherein the enclosure comprises an optical window that is aligned with the reaction zones of the reaction membrane when the test strip holder is moved to the post-actuation position to allow for optical measurements of the reaction zones during assay results measurement.

13. The test cartridge of claim 1, wherein the enclosure comprises a first indicator to indicate when the test cartridge is new and when it is used.

14. The test cartridge of claim 1, wherein the enclosure comprises a second indicator to indicate when the test cartridge is expired.

15. The test cartridge of claim 1, wherein the enclosure comprises a third indicator to indicate when the test cartridge is exposed to prohibited humidity or temperature during storage.

16. The test cartridge of claim 1, wherein the enclosure comprises first and second enclosure pieces to provide the housing for the test cartridge to protect the test strip from contamination or exposure to environmental humidity.

17. The test cartridge of claim 1, wherein the test cartridge further comprises an NFC tag disposed with the enclosure, the NFC tag being adapted to store information about the test cartridge including information about at least one of a type of assay that is performed by the test cartridge and parameters that are used to determine the assay results from assay measurements.

18. The test cartridge of claim 1, wherein the test strip and the buffer membrane are disposed within the test cartridge to perform a lateral flow assay.

19. An electronic reader for performing an assay test and measuring test results, wherein the electronic reader comprises:

a slot for receiving a test cartridge that allows for an automated assay of various analytes in a sample, wherein the test cartridge comprises;

a capillary assembly to receive, store and release the sample;

a buffer capsule for storing and releasing a buffer liquid;

a buffer membrane to receive the buffer liquid during the assay;

a test strip that is coupled to the buffer membrane and adapted to perform the assay after receiving the sample and the buffer liquid;

a test strip holder adapted to hold the test strip and the buffer membrane and move towards the capillary assembly and the buffer membrane to provide the sample to the test strip and the buffer liquid to the buffer membrane when the assay is performed; and

an enclosure for providing a housing for the test cartridge;

an optical system for obtaining optical measurements from the test cartridge; and

a microprocessor that is coupled to the optical system, the microprocessor being adapted to control the electronic reader, receive the optical measurements and determine assay results from the optical measurements.

20. The electronic reader of claim 19, wherein the cartridge further comprises a tab in the slot that provides a force to move the test strip holder of the test cartridge to begin the assay when the test cartridge is inserted into the slot thereby allowing for single user action for performing the assay and measuring the assay results.

21. The electronic reader of claim 20, wherein the slot is vertical to provide a vertical orientation for the test cartridge which aids in movement of the sample along the test strip and the buffer liquid along the buffer membrane and the test strip.

22. The electronic reader of claim 19, wherein the electronic device further comprises a display to show the assay results and/or error information when an error is encountered during the assay or operation of the electronic reader.

23. The electronic reader of claim 19, wherein the electronic device further comprises an NFC reader for reading information about the test cartridge including at least one of a type of assay that is performed by the test cartridge and parameters that are used to determine the assay results from assay measurements.

24. The electronic reader of claim 19, wherein the electronic device further comprises a communication module for pairing and/or communicating with an application of an external device for sending the assay results and associated assay test information.

25. The electronic reader of claim 24, wherein the communication module is adapted to use a Bluetooth or WiFi communication protocol.

26. A kit for performing an assay for point of care testing, wherein the kit comprises:

at least one test cartridge that allows for an automated assay of various analytes in a sample, wherein the test cartridge comprises;

a capillary assembly to receive, store and release the sample;

a buffer capsule for storing and releasing a buffer liquid;

a buffer membrane to receive the buffer liquid during the assay;

a test strip that is coupled to the buffer membrane and adapted to perform the assay after receiving the sample and the buffer liquid;

a test strip holder adapted to hold the test strip and the buffer membrane and move towards the capillary assembly and the buffer membrane to provide the sample to the test strip and the buffer liquid to the buffer membrane when the assay is performed;

an enclosure for providing a housing for the test cartridge; and

an electronic reader for performing an assay test and measuring test results, wherein the electronic reader comprises;

a slot for receiving the at least one test cartridge;

an optical system for obtaining optical measurements from the at least one test cartridge; and

a microprocessor that is coupled to the optical system, the microprocessor being adapted to control the electronic reader, receive the optical measurements and determine assay results from the optical measurements.

27. A method of measuring a sample with at least one analyte of interest, wherein the method comprises:

providing a sample to a test cartridge having a test strip and a buffer membrane for performing an assay on the sample to detect the at least one analyte of interest;

inserting the test cartridge into an electronic reader which provides an actuation force to initiate the assay in the test cartridge;

measuring assay results using the electronic reader; and

displaying, storing and/or sending the assay results using the electronic reader.

28. The method of claim 27, wherein the test cartridge allows for an automated assay of various analytes in a sample, wherein the test cartridge comprises:

a capillary assembly to receive, store and release the sample;

a buffer capsule for storing and releasing a buffer liquid;

a buffer membrane to receive the buffer liquid during the assay;

a test strip that is coupled to the buffer membrane and adapted to perform the assay after receiving the sample and the buffer liquid;

a test strip holder adapted to hold the test strip and the buffer membrane and move towards the capillary assembly and the buffer membrane to provide the sample to the test strip and the buffer liquid to the buffer membrane when the assay is performed; and

an enclosure for providing a housing for the test cartridge.

29. The method of claim 27, wherein the electronic reader is for performing an assay test and measuring test results, wherein the electronic reader comprises:

a slot for receiving a test cartridge that allows for an automated assay of various analytes in a sample, wherein the test cartridge comprises;

a capillary assembly to receive, store and release the sample;

a buffer capsule for storing and releasing a buffer liquid;

a buffer membrane to receive the buffer liquid during the assay;

a test strip that is coupled to the buffer membrane and adapted to perform the assay after receiving the sample and the buffer liquid;

a test strip holder adapted to hold the test strip and the buffer membrane and move towards the capillary assembly and the buffer membrane to provide the sample to the test strip and the buffer liquid to the buffer membrane when the assay is performed;

an enclosure for providing a housing for the test cartridge an optical system for obtaining optical measurements from the test cartridge; and

a microprocessor that is coupled to the optical system, the microprocessor being adapted to control the electronic reader, receive the optical measurements and determine assay results from the optical measurements.