Optical Assay Device with Pneumatic Sample Actuation

• US 20130189794A1
• Filed: 12/21/2012
• Published: 07/25/2013
• Est. Priority Date: 12/23/2011
• Status: Active Grant

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Emeric, Pierre, Davis, Graham, Ewart, Thomas, Gershtein, Sergey
• Granted Patent: US 9,377,475 B2
• Time in Patent Office: Days
• US Class Current: 436/501
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2300/0627 Sensor or part of a sensor is integrated
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0861 Configuration of multiple channels and/or chambers in a single devices
• CPC Class Codes: B01L 2400/0475 specific mechanical means and fluid pressure
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: G01N 2035/00108 Test strips, e.g. paper
• CPC Class Codes: G01N 2035/00128 with pressing or squeezing devices
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/76 Human chorionic gonadotropin including luteinising hormone, follicle stimulating hormone, thyroid stimulating hormone or their receptors
• CPC Class Codes: G01N 35/00029 provided with flat sample substrates, e.g. slides G01N35/028 takes precedence

Abstract

This invention relates generally to devices and methods for performing optical and electrochemical assays and, more particularly, to test devices, e.g., cartridges, methods and systems, wherein the test devices have an entry port configured to receive a test sample into a holding chamber; a first conduit having at least one lateral flow test strip; and a displacement device, such as a pneumatic pump, configured to move a portion of said test sample from said holding chamber into said first conduit. The present invention is particularly useful for performing immunoassays and/or electrochemical assays at the point-of-care.

Claims

1. A testing device comprising:

an entry port configured to receive a test sample into a holding chamber;

a first conduit comprising at least one lateral flow test strip; and

a displacement device configured to move a portion of said test sample from said holding chamber into said first conduit.

2. The testing device of claim 1, further comprising a position sensor configured to provide a position of said portion of said test sample based on conductance of said test sample in at least one predetermined location of said testing device.

3. The testing device of claim 1, further comprising at least one imaging area configured to provide a position of said portion of said test sample based on a captured image of said test sample passing through said at least one imaging area.

4. The testing device of claim 1, further comprising:

a labeling zone; and

a waste chamber.

5. The testing device of claim 4, wherein said displacement device is further configured to move said portion of said test sample from said holding chamber to said labeling zone.

6. The testing device of claim 5, wherein displacement device is further configured to move said portion of said test sample from said labeling zone to said first conduit.

7. The testing device of claim 6, wherein displacement device is further configured to move said portion of said test sample from said first conduit to said waste chamber.

8. The testing device of claim 1, further comprising a second conduit comprising at least one lateral flow test strip.

9. The testing device of claim 8, wherein said displacement device is further configured to move said portion of said test sample from said holding chamber into said first conduit and said second conduit.

10. The testing device of claim 1, further comprising a second conduit comprising at least one electrochemical sensor.

11. The testing device of claim 10, wherein said displacement device is further configured to move said portion of said test sample from said holding chamber into said first conduit and said second conduit.

12. A testing system comprising:

a testing device comprising;

an entry port configured to receive a test sample into a holding chamber;

a first conduit comprising at least one lateral flow test strip; and

displacement device configured to move a portion of said test sample from said holding chamber into said first conduit; and

an instrument comprising a receiving port configured to receive and engage said testing device.

13. The testing system of claim 12, wherein said instrument further comprises an optical imager for reading an optical signal from said at least one lateral flow test strip.

14. The testing system of claim 13, wherein said optical imager is configured to simultaneously read said optical signal and a bar code on said testing device.

15. The testing system of claim 12, wherein said instrument further comprises a position detector configured to determine a position of said portion of said test sample in said testing device.

16. The testing system of claim 15, wherein said position detector is an electrical circuit that is configured to determine the position of said portion of said test sample based on conductance of said test sample in at least one predetermined location of said testing device.

17. The testing system of claim 15, wherein said position detector is an imager that is configured to determine the position of said portion of said test sample based on a captured image of said test sample passing through at least one predetermined location of said testing device.

18. The testing system of claim 15, wherein said instrument further comprises a processor configured to control a pneumatic pump to actuate said displacement device based on the determined position of said portion of said test sample.

19. The testing system of claim 18, wherein said testing device further comprises:

a labeling zone; and

a waste chamber.

20. The testing system of claim 19, wherein said processor is further configured to control said pneumatic pump to move said portion of said test sample from said holding chamber to said labeling zone.

21. The testing system of claim 20, wherein said processor is further configured to control said pneumatic pump to move said portion of said test sample from said labeling zone to said first conduit.

22. The testing system of claim 21, wherein said processor is further configured to control said pneumatic pump to move said portion of said test sample from said first conduit to said waste chamber.

23. The testing system of claim 19, wherein said testing device further comprises a second conduit comprising at least one lateral flow test strip.

24. The testing system of claim 23, wherein said processor is further configured to control said pneumatic pump to move said portion of said test sample from said holding chamber into said first conduit and said second conduit.

25. The testing system of claim 19, wherein said testing device further comprises a second conduit comprising at least one electrochemical sensor.

26. The testing device of claim 25, wherein said processor is further configured to control said pneumatic pump to move said portion of said test sample from said holding chamber into said first conduit and said second conduit.

27. A computer system for testing an analyte, the system comprising:

a CPU, a computer readable memory and a computer readable storage media;

first program instructions to actuate a pneumatic pump using a processor to move a portion of a test sample in a testing device from a holding chamber into a first conduit, said first conduit comprising a detection zone including a plurality of capture antibodies; and

second program instructions to capture an image of said detection zone,

wherein said first and said second program instructions are stored on the computer readable storage media for execution by the CPU via the computer readable memory.

28. The computer system of claim 27 further comprising:

third program instructions to actuate said pneumatic pump to move another portion of said test sample in said testing device into a second conduit; and

fourth program instructions to determine an electrochemical characteristic of said another portion of said test sample in said second conduit.

29. The computer system of claim 27, further comprising:

third program instructions to detect a location of said portion of said test sample in said testing device at a predetermined location; and

fourth program instructions to actuate said pneumatic pump to move said portion of said test sample upon detection of said portion of said test sample at the predetermined location.

30. An analyte test cartridge comprising:

a sample entry port configured to receive a test sample;

a sample holding chamber;

a labeled antibody for an analyte in said test sample;

a displacement device configured to move said test sample through at least a portion of said test cartridge;

a conduit; and

a porous plug with a capture antibody for said analyte,

wherein said sample holding chamber is connected to said closable sample entry port, said displacement device, and said conduit;

wherein said labeled antibody is coated on at least a portion of said conduit;

wherein said labeled antibody is configured to dissolve into said test sample; and

wherein said porous plug with said capture antibody is positioned in said conduit.

31. The analyte test cartridge of claim 30, wherein said label is an optically detectable moiety.

32. The analyte test cartridge of claim 30, further comprising a waste chamber positioned subsequent to said porous plug.

33. The analyte test cartridge of claim 32, wherein said porous plug is aligned with an optical detector in an instrument.

34. The analyte test cartridge of claim 30, further comprising a plasma separator positioned in at least a portion of said sample holding chamber proximate to said sample entry port.

35. The analyte test cartridge of claim 34, wherein said test sample is whole blood when received at said sample entry port and said test sample is plasma subsequent to said sample holding chamber.

36. A cartridge for detection of an analyte in a sample, the cartridge comprising:

an entry port for receiving said sample into a holding chamber;

a conduit with a bead reagent that is configured to dissolve into said sample;

a wicking matrix comprising an immobilized antibody that is configured to bind with said analyte; and

a displacement device configured to move said sample into said conduit, mix said bead reagent with said sample to form a complex of said analyte with said bead reagent, and move said sample to said wicking matrix to capture said complex.

37. A method of performing an analyte assay comprising:

introducing a sample into a sample holding chamber of a cartridge through a sample entry port;

activating a pump to move at least a portion of said sample into a conduit;

oscillating said sample to dissolve an optically labeled antibody into said sample and to permit binding of said optically labeled antibody with an analyte to form a complex;

waiting a predetermined amount of time;

activating said pump after waiting said predetermined amount of time to move said sample to a porous plug in said conduit, wherein at least a portion of said porous plug comprises an immobilized antibody configured to bind to said complex; and

activating an optical detector aligned with said porous plug to determine a presence or amount of retained optically labeled antibody.

38. A computer program product comprising a computer usable storage medium having readable program code embodied in the storage medium, wherein the computer program product includes at least one component operable to:

actuate a pneumatic pump to move a portion of a test sample in a testing device from a holding chamber into a conduit, a portion of said conduit comprising a capture antibody; and

actuate an imager aligned with said portion of said conduit to capture an image of said portion of said conduit.