Assays

• US 7,238,537 B2
• Filed: 09/04/2001
• Issued: 07/03/2007
• Est. Priority Date: 02/17/1989
• Status: Expired due to Fees

• Current Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories)
• Original Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories)
• Inventors: Davis, Paul James, May, Keith, Prior, Michael Evans
• Primary Examiner(s): NGUYEN, BAO THUY L
• Application Number:
  US09/944,389
• Publication Number:
  US 20030207465A1
• Time in Patent Office: 2,128 Days
• Field of Search: 436/514, 436/518, 436/525, 436/528, 436/530, 436/541, 436/810, 436/814, 436/818, 435/7.92, 435/7.1, 435/7.95, 435/805, 435/806, 435/810, 435/970, 435/287.8, 422 56- 58
• US Class Current: 436/514
• CPC Class Codes: G01N 33/54386 Analytical elements
• 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 33/76 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 435/806 Fertility tests
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10S 436/814 Pregnancy
• CPC Class Codes: Y10S 436/818 Human chorionic gonadotropin

Abstract

An analytical test device incorporating a dry porous carrier to which a liquid sample, eg. urine, suspected of containing an analyte such as HCG or LH can be applied indirectly, the device also incorporating a labelled specific binding reagent which is freely mobile in the porous carrier when in the moist state, and an unlabelled specific binding reagent which is permanently immobilized in a detection zone on the carrier material, the labelled and unlabelled specific binding reagents being capable of participating in either a sandwich reaction or a competition reaction in the presence of the analyte, in which prior to the application to the device of a liquid sample suspected of containing the analyte, the labelled specific binding reagent is retained in the dry state in a macroporous body, eg. of plastics material having a pore size of 10 microns or greater, through which the applied liquid sample must pass en route to the porous carrier material, the labelled specific binding reagent being freely soluble or dispersible in any liquid sample which enters the macroporous body.

Claims

1. An immunoassay test device, comprising:

a test strip comprising;

a porous sample receiving member, configured to receive a liquid sample,

a macroporous body,

a porous carrier comprising a detection zone,

a first binding reagent for binding an analyte, the first binding reagent is immobilized in the detection zone,

a labeled binding reagent comprising a particulate label portion and a binding portion for binding the analyte, the labeled binding reagent is disposed in the macroporous body in a dry state and is mobilizable by liquid that passes along a flow path, and

the labeled binding reagent and the first binding reagent are configured to bind the analyte and to form an immobilized and directly-detectable product in the detection zone, if the analyte is present in liquid received by the sample receiving member;

wherein,

the test strip defines a flow path along which liquid received by the sample receiving member can pass to the macroporous body and thereafter to the porous carrier.

2. The immunoassay test device of claim 1, wherein the porous carrier comprises nitrocellulose.

3. The immunoassay test device of claim 2, wherein the porous carrier is a nitrocellulose strip.

4. The immunoassay test device of claim 2, wherein the test strip further comprises a backing layer of moisture impermeable material configured to support the porous carrier.

5. The immunoassay test device of claim 4, wherein the moisture impermeable material is a strip of plastic material.

6. The immunoassay test device of claim 2, wherein the macroporous body is a porous plastic body.

7. The immunoassay test device of claim 2, wherein the immunoassay test device is an immunoassay test device for determining pregnancy in a human female.

8. The immunoassay test device of claim 7, wherein the first binding reagent is capable is specifically binding the analyte.

9. The immunoassay test device of claim 8, wherein the analyte is human chorionic gonadotropin (hCG).

10. The immunoassay test device of claim 7, wherein the liquid that can pass from the macroporous body to the porous carrier can pass to a location of the porous carrier that is separated from the detection zone.

11. The immunoassay test device of claim 7, wherein the particulate label portion comprises a colored particle.

12. The immunoassay test device of claim 11, wherein the colored particle is a latex particle.

13. The immunoassay test device of claim 12, wherein the porous carrier is a nitrocellulose strip.

14. The immunoassay test device of claim 2, wherein the macroporous body and the porous carrier are made of different materials.

15. The immunoassay test device of claim 1, wherein the macroporous body is in direct contact with the sample receiving member and with the porous carrier.

16. The immunoassay test device of claim 15, wherein the macroporous body only contacts the porous carrier at a location of the porous carrier that is separated from the detection zone.

17. The immunoassay test device of claim 1, wherein the particulate label portion comprises a colored particle.

18. The immunoassay test device of claim 17, wherein the colored particle is a latex particle.

19. The immunoassay test device of claim 18, wherein the immunoassay test device is an immunoassay test device for determining pregnancy in a human female.

20. The immunoassay test device of claim 19, wherein the first binding reagent is capable of specifically binding the analyte.

21. The immunoassay test device of claim 20, wherein the analyte is human chorionic gonadotropin (hCG).

22. The immunoassay test device of claim 18, wherein the macroporous body and the porous carrier are made of different materials.

23. The immunoassay test device of claim 18, wherein the porous carrier comprises nitrocellulose.

24. The immunoassay test device of claim 18, wherein the test strip further comprises a backing layer of moisture impermeable material configured to support the porous carrier.

25. The immunoassay test device of claim 18, wherein the liquid that can pass from the macroporous body to the porous carrier can pass to a location of the porous carrier that is separated from the detection zone.

26. The immunoassay test device of claim 1, wherein the device comprises a housing, and only a portion of the sample receiving member resides within the housing.

27. The immunoassay test device of claim 26, wherein all of the macroporous body resides within the housing.

28. The immunoassay test device of claim 27, wherein the porous carrier comprises nitrocellulose.

29. The immunoassay test device of claim 28, wherein the porous carrier is a nitrocellulose strip.

30. The immunoassay test devuce of claim 26, wherein the macroporous body and the porous carrier are made of different materials.

31. The immunoassay test device of claim 26, wherein the porous carrier is a nitrocellulose strip.

32. The immunoassay test device of claim 31, wherein the test strip further comprises a backing layer of moisture impermeable material configured to support the porous carrier.

33. The immunoassay test device of claim 26, wherein the particulate label portion comprises a colored particle.

34. The immunoassay test device of claim 33, wherein the colored particle is a latex particle.

35. The immunoassay test device of claim 26, wherein the liquid that can pass from the macroporous body to the porous carrier can pass to a location of the porous carrier that is separated from the detection zone.

36. The immunoassay test device of claim 34, wherein the immunoassay test device is an immunoassay test device for determining pregnancy in a human female.

37. The immunoassay test device of claim 36, wherein the first binding reagent is capable of specifically binding the analyte.

38. The immunoassay test device of claim 37, wherein the analyte is human chorionic gonadotropin (hCG).

39. The immunoassay test device of claim 26, wherein the test strip defines a major axis and a length along the major axis of the sample receiving member is greater than a length along the major axis of the macroporous body.

40. The immunoassay test device of claim 2, wherein the test strip defines a major axis and a length along the major axis of the sample receiving member is greater than a length along the major axis of the macroporous body.

41. An immunoassay test device, comprising:

a test strip comprising;

a porous sample receiving member, configured to receive a liquid sample,

a macroporous body,

a porous nitrocellulose carrier comprising a detection zone,

a first binding reagent capable of specifically binding a gonadotropin compound, the first binding agent is immobilized in the detection zone,

a lableled binding reagent comprising a colored particulate label portion and a binding portion for the gonadotropin compound, disposed in the macroporous body in a dry state and is mobilizable by liquid that passes along a flow path, and

the labeled binding reagent and the first binding reagent are configured to bind the gonadotropin compound and to form an immobilized and directly-detectable product in the detection zone, if the gonadotropin compound is present in liquid received by the sample receiving member;

wherein,

the test strip defines a flow path along which liquid received by the sample receiving member can pass to the macroporous body and thereafter to the porous nitrocellulose carrier at a location separated from the detection zone.

42. The immunoassay test device of claim 41, wherein the gonadotropin compound is human chorionic gonadotropin (hCG).

43. The immunoassay test device of claim 41, wherein the device comprises a housing, and only a portion of the sample receiving member resides within the housing and all of the macroporous body resides within the housing.

44. The immunoassay test device of claim 43, wherein all of the macroporous body resides within the housing.

45. The immunoassay test device of claim 41, wherein the test strip defines a major axis and a length along the major axis of the sample receiving member is greater than a length along the major axis of the macroporous body.

46. The immunoassay test device of claim 41, wherein the colored particulate label portion comprises a latex particle.

52. The immunoassay test device of claim 43, wherein the particulate label portion comprises a colored particle.

53. The immunoassay test device of claim 52, wherein the particulate label portion comprises a latex particle.

54. The immunoassay test device of claim 53, wherein the carrier comprises nitrocellulose.

55. The immunoassay test device of claim 54, wherein the porous carrier is a nitrocellulose strip.

47. An immunoassay test device, comprising:

a test strip comprising;

a porous sample receiving member, configured to receive a liquid sample,

a macroporous body,

a porous carrier comprising a detection zone, and

a first binding reagent for binding an analyte or an analogue thereof,

a labeled reagent comprising a particulate label portion and the analyte or the analogue thereof, the labeled reagent is disposed in the macroporous body in a dry state and is mobilizable by liquid that passes along a flow path, and

the labeled binding reagent and the first binding reagent are configured to form an immobilized and directly-detectable product in the detection zone, wherein,

the test strip defines a flow path along which liquid received by the sample receiving member can pass to the macroporous body and thereafter to the porous carrier.

48. The immunoassay test device of claim 47, wherein the macroporous body and the porous carrier are made of different materials.

49. The immunoassay test device of claim 48, wherein the porous carrier comprises nitrocellulose.

50. The immunoassay test device of claim 49, wherein the porous carrier is a nitrocellulose strip.

51. The immunoassay test device of claim 49, wherein the macroporous body is a plastic.