Assays

• US 7,109,042 B2
• Filed: 02/12/2001
• Issued: 09/19/2006
• Est. Priority Date: 04/27/1987
• Status: Expired due to Fees

• Current Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories Incorporated)
• Inventors: Richards, Ian, May, Keith, Prior, Michael Evans
• Primary Examiner(s): Chin, Christopher L.
• Application Number:
  US09/780,351
• Publication Number:
  US 20010008774A1
• Time in Patent Office: 2,045 Days
• Field of Search: 422 56- 58, 422/61, 435/7.1, 435/287.1, 435/287.2, 435/287.7, 435/287.9, 435/805, 435/810, 435/970, 436/65, 436/169, 436/510, 436/514, 436/518, 436/524, 436/525, 436/528, 436/530, 436/534, 436/805, 436/810, 436/814, 436/817, 436/818
• US Class Current: 436/514
• CPC Class Codes: G01N 2800/368 Pregnancy complicated by disease or abnormalities of pregnancy, e.g. preeclampsia, preterm labour
• CPC Class Codes: G01N 30/90 Plate chromatography, e.g. thin layer or paper chromatography
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/548 Carbohydrates, e.g. dextran
• CPC Class Codes: G01N 33/549 with antigen or antibody entrapped within the carrier
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/58 involving labelled substances G01N33/53 takes precedence
• 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: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/962 Prevention or removal of interfering materials or reactants or other treatment to enhance results, e.g. determining or preventing nonspecific binding
• CPC Class Codes: Y10S 435/969 Multiple layering of reactants
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 435/975 Kit
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10S 436/814 Pregnancy
• CPC Class Codes: Y10S 436/817 : Steroids or hormones
• CPC Class Codes: Y10S 436/818 : Human chorionic gonadotropin
• CPC Class Codes: Y10S 436/906 : Fertility tests

Abstract

An analytical test device useful for example in pregnancy testing, comprises a hollow casing (500) constructed of moisture-impervious solid material, such as plastics materials, containing a dry porous carrier (510) which communicates indirectly with the exterior of the casing via a bibulous sample receiving member (506) which protrudes from the casing such that a liquid test sample can be applied to the receiving member and permeate therefrom to the porous carrier, the carrier containing in a first zone a labelled specific binding reagent is freely mobile within the porous carrier when in the moist state, and in a second zone spatially distinct from the first zone unlabelled specific binding reagent for the same analyte which unlabelled reagent is permanently immobilised on the carrier material and is therefore not mobile in the moist state, the two zones being arranged such that liquid sample applied to the porous carrier can permeate via the first zone into the second zone, and the device incorporating means, such as an aperture (508) in the casing, enabling the extent (if any) to which the labelled reagent becomes bound in the second zone to be observed. Preferably the device includes a removable cap for the protruding bibulous member.

Claims

1. A test device for determination of an analyte in a liquid sample, comprising:

(a) a nitrocellulose carrier,

(b) a binding reagent effective to capture analyte, when present, in a defined detection zone of the nitrocellulose carrier;

(c) a labeled reagent which is freely mobile in the nitrocellulose carrier in the presence of the liquid sample, said labeled reagent being selected such that it is captured in the detection zone when analyte is present in the liquid sample;

(d) a sample receiving member; and

(e) a control zone, disposed on or in the nitrocellulose carrier on a side of the detection zone remote from the sample receiving member, wherein the control zone comprises a control binding reagent which binds the labeled reagent whether or not analyte is present in the sample;

wherein liquid sample applied to the sample receiving member is transported to and then along the length of the nitrocellulose carrier to pass through the detection zone, and wherein the detection of labeled reagent in the detection zone is indicative of the presence of analyte in the liquid sample.

2. The device of claim 1, further comprising a hollow casing formed from a moisture impervious material, wherein the nitrocellulose carrier is disposed within the hollow casing and the sample receiving member connects the interior of the hollow casing to the exterior of the hollow casing.

3. The device of claim 2, wherein the hollow casing has an aperture formed therein to permit observation of the detection zone.

4. The device of claim 2, wherein the labeled reagent is a labeled antibody that specifically binds with the analyte.

5. The device of claim 4, wherein the labeled reagent comprises a direct label.

6. The device of claim 5, wherein the direct label is a particulate label.

7. The device of claim 6, wherein the particulate label is colloidal gold.

8. The device of claim 4, wherein, the binding reagent is an antibody that specifically binds with the analyte.

9. The device of claim 4, wherein the analyte is human chorionic gonadotropin, and both the labeled reagent and the binding reagent are antibodies that bind to different of human chorionic gonadotropin.

10. The device of claim 9, wherein the nitrocellulose carrier has a pore size of 1 to 20 microns.

11. The device of claim 4, wherein the nitrocellulose carrier has a pore size of 1 to 20 microns.

12. The device of claim 2, wherein the nitrocellulose carrier has a pore size of 1 to 20 microns.

13. The device of claim 2, wherein the labeled reagent is disposed in a reagent zone on or in the nitrocellulose carrier, said reagent zone being spatially separate from the detection zone, and disposed between the sample receiving member and the detection zone.

14. The device of claim 1, wherein the nitrocellulose carrier has a pore size of 1 to 20 microns.

15. The device of claim 1, wherein the labeled reagent is disposed in a reagent zone on or in the nitrocellulose carrier, said reagent zone being spatially separate from the detection zone, and disposed between the sample receiving member and the detection zone.

16. The device of claim 15, wherein the labeled reagent is a labeled antibody that specifically binds with the analyte.

17. The device of claim 16, wherein the labeled reagent comprises a direct label.

18. The device of claim 17, wherein the direct label is a particulate label.

19. The device of claim 18, wherein the particulate label is colloidal gold.

20. The device of claim 16, wherein the binding reagent is an antibody that specifically binds with the analyte.

21. The device of claim 16, wherein the analyte is human chorionic gonadotropin, and both the labeled reagent are antibodies that bind to different epitopes of human chorionic gonadotropin.

22. The device of claim 21, wherein the nitrocellulose carrier has a pore size of 1 to 20 microns.

23. The device of claim 15, wherein the nitrocellulose carrier has a pore size of 1 to 20 microns.

24. A test device for determination of an analyte in a liquid sample, comprising:

(a) a nitrocellulose carrier,

(b) a binding reagent effective to capture analyte, when present, in a defined detection zone of the nitrocellulose carrier;

(c) a labeled reagent which is freely mobile in the nitrocellulose carrier in the presence of the liquid sample, said labeled reagent being selected such that it is captured in the detection zone when analyte is present in the liquid sample;

(d) a sample receiving member; and

(e) a hollow casing formed from a moisture impervious material, wherein nitrocellulose carrier is disposed within the hollow casing, the sample receiving member connects the interior of the hollow casing to the exterior of the hollow casing;

wherein liquid sample applied to the sample receiving member is transported to and then along the length of the nitrocellulose carrier to pass through the detection zone, and wherein the detection of labeled reagent in the detection zone is indicative of the presence of analyte in the liquid sample.

25. A test device for determination of an analyte in a liquid sample, comprising:

(a) a carrier through which the liquid sample can flow;

(b) a binding reagent effective to capture analyte, when present, in a defined detection zone of the carrier;

(c) a labeled reagent which in freely mobile in the carrier in the presence of the liquid sample, said labeled reagent being selected such that it is captured in the detection zone when analyte is present in the liquid sample;

(d) a sample receiving member; and

(e) a control zone, disposed on or in the nitrocellulose carrier on a side of the detection zone remote from the sample receiving member, wherein the control zone comprises a control binding reagent which binds the labeled reagent whether or not analyte is present in the sample,

wherein liquid sample applied to the sample receiving member is transported to and then along the length of the carrier to pass through the detection zone, and wherein the detection of labeled reagent in the detection zone is indicative of the presence of analyte in the liquid sample.

33. The test device of claim 25, wherein the labeled reagent comprises a particulate label.

34. The test device of claim 33, wherein the particulate label is a colored particle.

35. The test of claim 34, wherein the device comprises a test strip, the test strip comprises the sample receiving member and the nitrocellulose carrier, and, when the test device is in a dry unused state, the labeled reagent is in dry from on the test strip.

36. The test device of claim 35, wherein the labeled reagent comprises an antibody that specifically binds to the analyte.

37. The test device of claim 36, wherein the analyte is human chorionic gonadotropin, that antibody of the labeled reagent binds to an epitope of human chorionic gonadotroin, and the binding reagent comprises an antibody that binds to an different epitope of human chorionic gonadotropin.

38. The test device of claim 34, wherein the sample receiving member is a porous member that extends from the interior of the hollow casing through an aperture in the hollowing casing to the exterior of the hollow casing.

26. The device of clam 25, wherein the labeled reagent is disposed in a reagent zone on or in the carrier, said reagent zone being spatially separate from the detection zone, and disposed between the sample receiving member and the detection zone.

27. The device of claim 26, wherein the labeled reagent is a labeled antibody that specifically binds with the analyte.

28. The device of claim 27, wherein the labeled reagent comprises a direct label.

29. The device of claim 28, wherein the direct label is a particulate label.

30. The device of claim 29, wherein the particulate label is colloidal gold.

31. The device of claim 27, wherein the binding reagent is an antibody that specifically binds with the analyte.

32. The device of claim 27, wherein the analyte is human chorionic gonadotropin, and both the labeled reagent and the binding reagent are antibodies that bind to different epitopes of human chorionic gonadotropin.