Reader Devices for Optical and Electrochemical Test Devices

• US 20130162981A1
• Filed: 12/21/2012
• Published: 06/27/2013
• 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 9,194,859 B2
• Time in Patent Office: Days
• US Class Current: 356/72
• CPC Class Codes: G01N 2021/751 Comparing reactive/non reactive substances
• CPC Class Codes: G01N 2021/752 Devices comprising reaction zones
• CPC Class Codes: G01N 2021/757 using immobilised reagents
• CPC Class Codes: G01N 2021/7763 Sample through flow
• CPC Class Codes: G01N 2035/00752 bar codes
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 33/48 Biological material, e.g. blood, urine G01N33/02, G01N33/26, G01N33/44, G01N33/46 take precedence; Haemocytometers counting blood corpuscules distributed over a surface by scanning the surface G06M11/02
• CPC Class Codes: G01N 33/48785 Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply

Abstract

This invention relates generally to devices and methods for performing optical and electrochemical assays and, more particularly, to devices having optical and electrochemical detectors and to methods of performing optical and electrochemical assays using such devices. The present invention is particularly useful for performing immunoassays and/or electrochemical assays at the point-of-care.

Claims

1. A reader device for reading an optical or electrochemical test cartridge, the reader device comprising:

a housing including a cartridge receiving port configured to receive said optical or electrochemical test cartridge;

an optical sensor within said port configured to read a first signal from an optical feature of said optical test cartridge; and

an electrical connector within said port configured to mate with one or more electrodes of said electrochemical test cartridge and receive a second signal therefrom,

wherein said reader device is configured to provide a qualitative, semi-quantitative, or quantitative analysis display based on either or both said first signal and/or said second signal.

2. The reader device of claim 1, further comprising a processor configured to provide said display based on either or both said first signal and/or said second signal.

3. The reader device of claim 1, further comprising at least one locating means configured to position said optical or electrochemical test cartridge in said housing with respect to said optical sensor or said electrical connector.

4. The reader device of claim 1, further comprising a lip surrounding said port and configured to engage with a light baffle on said optical test cartridge.

5. The reader device of claim 2, wherein said optical sensor comprises an optical imager, said optical feature comprises an optical assay, and said optical imager is configured to image said optical assay of said optical test cartridge.

6. The reader device of claim 5, wherein said optical assay is a qualitative or semi-quantitative lateral flow test.

7. The reader device of claim 5, wherein said optical imager is further configured to image a code of said optical test cartridge.

8. The reader device of claim 7, wherein said code is a two-dimensional barcode comprising information, and said optical imager is further configured to obtain and transmit said information to said processor.

9. The reader device of claim 8, wherein said processor is further configured to display said information with said display obtained from either or both said first signal and/or said second signal.

10. The reader device of claim 9, wherein said optical sensor further comprises a light source configured to illuminate said optical assay and said two-dimensional barcode.

11. The reader device of claim 10, wherein said light source comprises a first light-emitting diode configured to illuminate said optical assay and a second light-emitting diode configured to illuminate said two-dimensional barcode.

12. The reader device of claim 11, wherein said optical imager is further configured to image said two-dimensional barcode and said optical assay at a same time.

13. The reader device of claim 1, wherein said optical test cartridge is a qualitative or semi-quantitative lateral flow test device or a combined qualitative or semi-quantitative lateral flow test device and quantitative non-lateral flow test device.

14. The reader device of claim 13, wherein said optical test cartridge comprises a testing system operable to detect an analyte selected from the group consisting of:

hCG and drugs of abuse.

15. The reader device of claim 1, wherein said optical test cartridge comprises a testing system operable to detect a predetermined analyte in a biological sample selected from the group consisting of:

urine, blood, plasma, serum, and amended forms thereof.

16. The reader device of claim 1, wherein said electrochemical test cartridge is a quantitative non-lateral flow test device or a combined qualitative or semi-quantitative lateral flow test device and quantitative non-lateral flow test device.

17. The reader device of claim 15, wherein said electrochemical test cartridge comprises a testing system operable to detect an analyte selected from the group consisting of:

hCG, K, Na, Cl, Ca, Mg, pH, pO2, pCO2, glucose, urea, creatinine, lactate, CKMB, TnI, TnT, BNP, NTproBNP, proBNP, TSH, D-dimer, PSA, PTH, NGAL, galectin-3, AST, ALT, albumin, phosphate and ALP.

18. The reader device of claim 1, wherein said electrochemical test cartridge comprises a testing system operable to detect a predetermined analyte in a biological sample selected from the group consisting of:

urine, blood, plasma, serum, and amended forms thereof.

19. An instrument comprising:

a housing including a cartridge receiving port configured to receive a plurality of testing cartridges, wherein said plurality of testing cartridges comprises at least two selected from the group consisting of;

a qualitative or semi-quantitative lateral flow test device;

a quantitative non-lateral flow test device; and

a combined qualitative or semi-quantitative lateral flow test device and a quantitative non-lateral flow test device.

20. The instrument of claim 19, further comprising:

at least one detector; and

at least one locating means configured to position at least one of said plurality of testing cartridges in said housing with respect to the at least one detector.

21. The instrument of claim 20, further comprising a lip surrounding said cartridge receiving port and configured to engage with a light baffle on at least one of said plurality of testing cartridges.

22. The instrument of claim 19, further comprising at least one detector comprising an electrical connector configured to connect to a quantitative electrochemical sensor in at least one of said plurality of testing cartridges.

23. The instrument of claim 19, further comprising at least one detector comprising an optical imager configured to image an optical assay in at least one of said plurality of testing cartridges.

24. The instrument of claim 23, wherein said optical imager is further configured to image a code on at least one of said plurality of testing cartridges.

25. The instrument of claim 24, wherein said code is a two-dimensional barcode comprising information, and said optical imager is further configured to obtain said information and report said information with at least one result obtained from said optical assay.

26. The instrument of claim 25, wherein said at least one detector further comprises a light source configured to illuminate said optical assay and said two-dimensional barcode.

27. The instrument of claim 26, wherein said light source comprises a first light-emitting diode configured to illuminate said optical assay and a second light-emitting diode configured to illuminate said two-dimensional barcode.

28. The instrument of claim 27, wherein the imager is further configured to image said two-dimensional barcode and said optical assay at a same time.

29. The instrument of claim 19, wherein said qualitative or semi-quantitative lateral flow test device or said combined qualitative or semi-quantitative lateral flow test device and said quantitative non-lateral flow test device comprises a testing system operable to detect an analyte selected from the group consisting of:

hCG and drugs of abuse.

30. The instrument of claim 19, wherein said quantitative non-lateral flow test device or said combined qualitative or semi-quantitative lateral flow test device and said quantitative non-lateral flow test device comprises a testing system operable to detect an analyte selected from the group consisting of:

hCG, K, Na, Cl, Ca, Mg, pH, pO2, pCO2, glucose, urea, creatinine, lactate, CKMB, TnI, TnT, BNP, NTproBNP, proBNP, TSH, D-dimer, PSA, PTH, NGAL, galectin-3, AST, ALT, albumin, phosphate and ALP.

31. The instrument of claim 19, wherein said qualitative or semi-quantitative lateral flow test device;

said quantitative non-lateral flow test device; and

said combined qualitative or semi-quantitative lateral flow test device and a quantitative non-lateral flow test device are configured to test for a predetermined analyte in a biological sample selected from the group consisting of;

urine, blood, plasma, serum, and amended forms thereof.

32. An analyte testing system comprising:

an instrument including a housing with a cartridge receiving port; and

a plurality of testing cartridges including at least two selected from the group consisting of;

a qualitative or semi-quantitative lateral flow test device;

a quantitative non-lateral flow test device;

and a combined qualitative or semi-quantitative lateral flow test device and a quantitative non-lateral flow test device,

wherein said cartridge receiving port is configured to receive said plurality of testing cartridges.

33. The analyte testing system of claim 32, further comprising a first detector comprising an electrical connector configured to connect to a quantitative electrochemical sensor in at least one of said plurality of testing cartridges.

34. The analyte testing system of claim 33, further comprising a second detector comprising an optical imager configured to image an optical assay in at least one of said plurality of testing cartridges.

35. The analyte testing system of claim 32, wherein said instrument further comprises a lip surrounding said cartridge receiving port, the lip being configured to engage with a light baffle on at least one of said plurality of testing cartridges.

36. An instrument for receiving at least two types of pregnancy test cartridges, the instrument comprising:

a housing with a cartridge receiving port that is configured to receive the at least two types of pregnancy test cartridges, wherein said at least two types of pregnancy test cartridges comprise a qualitative or semi-quantitative lateral flow hCG test device and a quantitative non-lateral flow hCG test device.

37. The instrument of claim 36, wherein the quantitative non-lateral flow hCG test device comprises an electrochemical immunosensor.

38. The instrument of claim 36, further comprising:

a first detector comprising an electrical connector configured to connect to the electrochemical immunosensor in said quantitative non-lateral flow hCG test device; and

a second detector comprising an optical imager configured to image an optical assay in said qualitative or semi-quantitative lateral flow hCG test device.

39. An instrument for receiving a biological sample test cartridge, the instrument comprising:

a connector configured to engage with electrical contacts on a first test cartridge; and

an imager configured to image a detection zone on a lateral flow test strip on said first test cartridge or a second test cartridge.

40. The instrument of claim 39, wherein said detection zone comprises control and signal lines of said lateral flow test strip.

41. The instrument of claim 39, wherein said imager is further configured to image a two-dimensional barcode adjacent said detection zone on said test cartridge.

42. The instrument of claim 41, wherein the imager is further configured to image said two-dimensional barcode and said detection zone at a same time.

43. The instrument of claim 39, wherein said electrical contacts are connected to a quantitative electrochemical sensor in the first test cartridge.

44. An instrument for sequentially receiving a plurality of cartridges, the instrument comprising:

a universal port configured to receive a series of at least two single-use test cartridges selected from the group consisting of;

optical test cartridge, electrochemical test cartridge, and opto-electrochemical test cartridge;

an electrical connector positioned in said universal port and configured to mate electrically with said electrochemical and said opto-electochemical test cartridges; and

an optical imager positioned in said universal port and configured to read said optical and said opto-electrochemical test cartridges.