Assay Device

• US 20100209297A1
• Filed: 04/09/2008
• Published: 08/19/2010
• Est. Priority Date: 04/10/2007
• Status: Active Grant

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories Incorporated)
• Inventors: Linley, Ezra, Eapen, Saji, Raj, Balbir
• Granted Patent: US 8,721,990 B2
• Time in Patent Office: Days
• US Class Current: 422/61
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: C12Q 2537/125 Sandwich assay format
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/689 related to pregnancy or the gonads
• CPC Class Codes: G01N 33/76 Human chorionic gonadotropin including luteinising hormone, follicle stimulating hormone, thyroid stimulating hormone or their receptors
• CPC Class Codes: Y10T 29/494 Fluidic or fluid actuated device making

Abstract

Disclosed is an assay device for the determination of the presence and/or extent if an analyte in a liquid sample over an extended concentration range comprising a first assay and a second assay, wherein the first assay for an analyte comprises a first flow-path having a sole detection zone capable of immobilising a labelled binding reagent and the second assay for said analyte comprises a second flow-path having a sole detection zone capable of immobilising a labelled binding reagent, wherein the presence of labelled binding reagent at the detection zones provides an indication of the presence and/or extent of analyte in said liquid sample.

Claims

1. An assay device for the determination of the presence and/or extent of an analyte in a liquid sample over an extended concentration range comprising a first assay and a second assay, wherein the first assay for an analyte comprises a first flow-path having a sole first assay detection zone capable of immobilising a labelled binding reagent and the second assay for said analyte comprises a second flow-path having a sole second assay detection zone capable of immobilising a labelled binding reagent, wherein the presence of labelled binding reagent at the detection zones provides an indication of the presence and/or extent of analyte in said liquid sample.

2. The device according to claim 1 wherein the first and/or second flow-path comprises a porous carrier.

3. The device according to claim 2 wherein the porous carrier is a lateral flow porous carrier.

4. The device according to claim 1 wherein the first and/or second assay comprises a mobilisable labelled binding reagent for the analyte provided upstream from said first and/or second assay detection zones.

5. The device according to claim 1 wherein the detection zone of the first and/or second assay comprises an immobilised binding reagent for the analyte.

6. The device according to claim 1 wherein the first assay is a sandwich assay and the second assay is a competition or inhibition assay.

7. The device according to claim 1 wherein the first assay comprises a mobilisable labelled binding reagent for an analyte provided upstream from a first assay detection zone, wherein the detection zone comprises an immobilised binding reagent for the analyte;

and wherein the second assay comprises a mobilisable labelled binding reagent for a first binding region of the analyte and a scavenger binding reagent for the analyte provided upstream from a second assay detection zone, wherein said second assay detection zone is capable of binding the labelled binding reagent.

8. The device according to claim 7 wherein the second assay detection zone comprises an immobilised binding reagent for the analyte.

9. The device according to claim 7 wherein for the second assay, the scavenger binding reagent has a higher binding affinity for the analyte than the mobilisable labelled binding reagent.

10. The device according to claim 7 wherein the mobilisable labelled binding reagent and the scavenger binding reagent of the second assay bind to respectively a first and second binding region of the analyte, the second assay detection zone comprises an immobilised binding reagent for a second binding region of the analyte.

11. The device according to claim 7 wherein the mobilisable labelled binding reagent and the scavenger binding reagent of the second assay are provided in the same region.

12. The device according to claim 7 wherein the scavenger binding reagent is provided in a mobilisable form.

13. The device according to claim 1 wherein the labelled binding reagent is labelled with an optically detectable particle.

14. The device according to claim 1, comprising a common porous sample receiver.

15. An assay device for determining the presence and/or extent of an analyte in a liquid sample comprising a first assay and a second assay wherein said first assay comprises a porous carrier having a detection zone comprising an immobilised binding reagent for an analyte and provided upstream from the detection zone is a mobilisable labelled binding reagent for said analyte;

and wherein said second assay comprises a detection zone comprising an immobilised binding reagent for the analyte and provided upstream from the detection zone is a mobilisable labelled binding reagent for the analyte and a scavenger reagent for said analyte, wherein detection of the presence of labelled binding reagent at the detection zones provides an indication of the presence and/or extent of analyte in said liquid sample.

16. The assay device according to claim 15 wherein the first assay is a high sensitivity analyte assay and the second assay is a low sensitivity analyte assay.

17. The device according to claim 15, comprising a housing wherein the first and second assays are provided within said housing.

18. The device according to claim 15 for the detection of hCG analyte in urine wherein the device comprises:

a) an illumination and detection means for illuminating and detecting labelled binding optical reagent at the detection zones;

b) a computation means for calculating a level of hCG or a value corresponding to the level of hCG;

c) a display means for displaying a result of the assay test;

d) a stored base threshold value, wherein a level of hCG corresponding to a value below the stored base threshold is indicative of being not pregnant and wherein a level of hCG corresponding to a value at or above the stored base threshold is indicative of being pregnant;

e) two further first and second stored threshold values wherein a level of hCG corresponding to a value less than or equal to a first threshold value is indicative of a level of pregnancy in a first range, a level of hCG corresponding to a value greater than the second threshold is indicative of a level of pregnancy in a third range, and a level of hCG corresponding to a value greater or equal to the first threshold but less than the second threshold is indicative of a level of hCG in a second range, wherein the display means is capable of indicating either a not pregnant condition, or a pregnant condition and the extent of pregnancy.

19. An assay kit for determining the presence and/or extent of an analyte in a liquid sample comprising a first assay and a second assay wherein said first assay comprises a porous carrier having a detection zone comprising an immobilised binding reagent for an analyte and provided upstream from the detection zone is a mobilisable labelled binding reagent for said analyte;

and wherein said second assay comprises a detection zone comprising an immobilised binding reagent for the analyte and provided upstream from the detection zone is a mobilisable labelled binding reagent for the analyte and a scavenger reagent for said analyte, wherein detection of the presence of labelled binding reagent at the detection zones provides an indication of the presence and/or extent of the analyte in the sample.