Assay device with shared zones

• US 7,879,624 B2
• Filed: 08/27/2008
• Issued: 02/01/2011
• Est. Priority Date: 09/01/2007
• Status: Active Grant

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Alere Switzerland GmbH (Abbott Laboratories Incorporated)
• Inventors: Sharrock, Stephen Paul
• Primary Examiner(s): NGUYEN, BAO THUY L
• Application Number:
  US12/199,284
• Publication Number:
  US 20090061534A1
• Time in Patent Office: 888 Days
• Field of Search: 436/514, 436/518, 436/805, 435/287.1, 435/287.2, 435/287.7, 435/808
• US Class Current: 436/518
• CPC Class Codes: G01N 2021/6439 with indicators, stains, dyes, tags, labels, marks
• CPC Class Codes: G01N 21/6428 Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" in vivo A61B5/00; immunoassay G01N33/53
• CPC Class Codes: G01N 21/76 Chemiluminescence; Bioluminescence
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 2201/062 LED's
• CPC Class Codes: G01N 2201/12 Circuits of general importance; Signal processing
• CPC Class Codes: G01N 2458/00 Labels used in chemical analysis of biological material
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/54389 with bidirectional or multidirectional lateral flow, e.g. wherein the sample flows from a single, common sample application point into multiple strips, lanes or zones
• CPC Class Codes: G01N 33/545 Synthetic resin
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/76 Human chorionic gonadotropin including luteinising hormone, follicle stimulating hormone, thyroid stimulating hormone or their receptors
• CPC Class Codes: Y10S 435/808 Optical sensing apparatus
• CPC Class Codes: Y10S 436/805 Optical property

Abstract

Disclosed is an assay device for determining the presence and/or extent of one or more analytes in liquid sample containing a) first and second assays each comprising a flow-path having a detection zone for immobilising a labelled binding reagent, wherein detection of a labelled binding reagent at one or both detection zones is indicative of the presence and/or extent of one or more analytes; b) a shared reference zone; c) one or more light sources to illuminate the detection zones and the reference zone; d) one or more photodetectors to detect light from the detection zones and the reference zone, which photodetector/s generate a signal, the magnitude of which signal is related to the amount of light detected; and e) signal processing means for processing signals from the photodetector/s.

Claims

1. An assay device for determining the presence and/or extent of one or more analyses in a liquid sample comprising:

a) a first and second test strips each comprising a flow-path, and each having a detection zone for immobilizing a labeled binding reagent, wherein detection of a labeled binding reagent at one or both detection zones is indicative of the presence and/or extent of one or more analytes;

b) a common sample application zone which fluidically connects the first and second test strips;

c) a shared reference zone;

d) one or more light sources to illuminate the detection zones and the reference zone;

e) one or more photodetectors to detect light from the detection zones and the reference zone, which photodetector generates a signal, the magnitude of which signal is related to the amount of light detected; and

f) signal processing means for processing signals from the photodetector.

2. The assay device according to claim 1, wherein the first and second test strips comprises a labeled binding reagent for an analyte or analyte analogue provided in a mobilizable form upstream from the detection zone in a dry state prior to use of the device.

3. The assay device according to claim 1, wherein the first and/or second test strip comprises a binding reagent for an analyte or a labeled binding reagent provided in an immobilized form at the detection zone.

4. The assay device according to claim 1, further comprising a shared control zone.

5. The assay device according to claim 1, wherein the shared reference zone is comprised as part of either the first or second test strip.

6. The assay device according to claim 4, wherein the control zone is comprised as part of either the first or second test strip.

7. The assay device according to claim 4, wherein the control zone is comprised as part of one and the shared reference zone is comprised as part of the other test strip.

8. The assay device according to claim 1, wherein the first test strip and second test strip are capable of detecting the presence of an analyte in different concentration ranges.

9. The assay device according to claim 1, wherein the flow-paths of the first and second test strips each comprise a porous carriers.

10. The assay device according to claim 9, wherein the porous carrier comprises nitrocellulose.

11. The assay device according to claim 1, comprising a single porous sample receiver provided upstream from the first and second test strips.

12. The assay device according to claim 1, further comprising a sink provided at the distal end of the test strip flow-paths.

13. The assay device according to claim 1, wherein the first and second test strips each comprise different amounts of labeled binding reagent.

14. The assay device according to claim 1, comprising a first test strip for the detection of an analyte in a lower range and a second test strip for the detection of analyte in a higher range.

15. The assay device according to claim 14 wherein the second test strip has a greater amount of labeled binding reagent than the first test strip.

16. The assay device according to claim 1, wherein the first test strip comprises a labeled binding reagent for the analyte provided upstream from a detection zone and the second test strip comprises a labeled binding reagent for the analyte and a second binding reagent for the analyte provided upstream from the detection zone.

17. The assay device according to claim 16, wherein the first test strip comprises a shared reference zone and the second test strip comprises a shared control zone.

18. The assay device according to claim 17, wherein the reference zone is provided downstream from the detection zone.

19. The assay device according to claim 17, wherein the control zone is provided downstream from the detection zone.

20. The assay device according to claim 1, wherein a photodetector detects light from a plurality of zones.

21. The assay device according to claim 20, comprising a single photodetector to detect light from the two detection zones, the reference zone and the control zone.

22. The assay device according to claim 21, comprising four light sources to illuminate the two detection zones, the reference zone and the control zone.

23. The assay device according to claim 20, wherein the amount of light detected by the photodetector from the detection zones and the reference zone is measured prior to addition of sample to the assay device and again after addition of sample to the assay device, and a ratio of the two measurements calculated for each zone.

24. The assay device according to claim 20, wherein a normalised percentage relative attenuation (% A) is calculated for the detection and/or control zones wherein:

25. The assay device according to claim 1, wherein the light source comprises one or more LEDs.

26. The assay device according to claim 1, wherein the analyte to be determined is hCG.

27. The assay device according to claim 1, wherein the liquid sample is urine.