Detachable-element assay device

• US 5,939,252 A
• Filed: 05/09/1997
• Issued: 08/17/1999
• Est. Priority Date: 05/09/1997
• Status: Expired due to Fees

• Current Assignee: Beckman Coulter Incorporated (Danaher Corporation)
• Original Assignee: Beckman Coulter Incorporated (Danaher Corporation)
• Inventors: Piasio, Roger N., Lennon, Donald J.
• Primary Examiner(s): Spiegel, Carol A.
• Application Number:
  US08/853,760
• Time in Patent Office: 830 Days
• Field of Search: 422/58, 435/4, 435/7.1, 435/7.2, 435/970, 435/975, 435/7.92-7.95, 435/7.32, 435/7.33, 435/7.34, 436/518, 436/525, 436/807, 436/809, 436/825
• US Class Current: 435/4
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 435/975 Kit
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10S 436/808 Automated or kit
• CPC Class Codes: Y10S 436/825 Pretreatment for removal of interfering factors from sample

Abstract

An assay device for detection or determination of an analyte in a sample uses either removably attachable components or hinged panels to provide greater flexibility and reduce manufacturing and storage costs. In one embodiment of the device, the device comprises: (1) a first opposable component including:(a) a first panel; (b) a second panel mounted on the first panel generally parallel to the first panel with space between the first and second panel, the second panel having an opening forming a first receptacle for a sample collection device; and (c) a second receptacle for a test strip formed by the first panel and the second panel; and (2) a second opposable component hingedly attached to the first opposable component. In this device, the first and second opposable components can be brought into operable contact so that fluid is expressed from the sample collection device and applied to the test strip for detection or determination of an analyte by a test performed on the test strip. Other embodiments of devices are included, as well as test kits and method of use of the devices.

Claims

1. An assay device for use with an insertable test strip for detection or determination of an analyte in a liquid sample, comprising:

(a) a first opposable component comprising;

(i) a first panel;

(ii) a second panel mounted on the first panel parallel to the first panel, the second panel comprising an opening forming a first receptacle for holding a sample collection device; and

(iii) a second receptacle for insertion of the test strip formed by the first panel and the second panel, the insertion occurring during performance of an assay; and

(b) a second opposable component hingedly attached to the first opposable component;

wherein the first and second opposable components are pressed together into operable contact to express fluid from the sample collection device to the inserted test strip thereby applying the sample to the test strip, the test strip comprising at least one assay reagent which reacts with the analyte to produce a detectable signal which indicates the presence or amount of the analyte in the sample.

2. The assay device of claim 1 wherein the test strip comprises a chromatographic medium comprising a first end and a second end such that when the test strip is inserted into the second receptacle and when the first and second opposable components are brought into said operable contact, the fluid expressed from the sample collection device is applied to the first end of the chromatographic medium.

3. The assay device of claim 1 wherein the second opposable component further comprises an aperture for view of at least a portion of the test strip.

4. A test kit comprising, in separately packaged containers:

(a) the assay device of claim 1; and

(b) at least one sample pretreatment or a second assay reagent for application either to the sample collection device or the test strip, respectively.

5. The test kit of claim 4 further comprising said sample collection device, wherein the sample collection device is impregnated with a second sample pretreatment reagent which reacts with said at least one sample pretreatment reagent to form an extraction reagent which extracts the analyte from the sample when the sample is applied to the sample collection device and contacted with the at least one sample pretreatment reagent.

6. The test kit of claim 5 wherein the extraction reagent formed is nitrous acid.

7. The assay for the detection or determination of said analyte comprising the steps of:

(a) providing the assay device of claim 1, the sample collection device and the test strip, wherein the test strip is covered wit a releasable liner by means of an adhesive layer,

(b) collecting the sample on the sample collection device;

(c) inserting the sample collection device with the sample into the first receptacle of the assay device of claim 1;

(d) removing the releasable liner from the test strip of step (a) and inserting the test strip from which the releasable liner has been removed into the second receptacle of the assay device of claim 1;

(e) pressing the first and second opposable components into said operable contact to express the fluid from the sample collection device to apply the sample to the test strip; and

(f) observing or measuring the presence or amount of the detectable signal produced on the test strip in response to the sample applied to it in order to detect or determine the analyte in the sample.

8. The assay of claim 7 further comprising the step of applying at least one sample pretreatment or a second assay reagent to the sample collection device prior to collecting the sample.

9. A test kit comprising, in separately packaged containers:

(a) the assay device of claim 1; and

(b) the test strip for insertion into the second receptacle of the assay device, the test strip being covered with a releasable liner by means of an adhesive layer.

10. An assay device for use with an insertable test strip for detection or determination of an analyte in a liquid sample, comprising:

(a) a first opposable component comprising;

(i) a first panel;

(ii) a second panel mounted on the first panel parallel to the first panel, the second panel comprising an opening forming a first receptacle for holding a swab; and

(iii) a second receptacle for insertion of the test strip formed by the first panel and the second panel, the insertion occurring during performance of an assay; and

(b) a second opposable component hingedly attached to the first opposable component;

wherein the first and second opposable components are pressed together into operable contact to express fluid from the swab to the inserted test strip thereby applying the sample to the test strip, the test strip comprising at least one assay reagent which reacts with the analyte to produce a detectable signal which indicates the presence or amount of the analyte in the sample.

11. An assay device for use with an insertable test strip for detection or determination of an analyte in a liquid sample, comprising:

(a) a first opposable component comprising;

(i) a first panel;

(ii) a second panel mounted on the first panel parallel to the first panel, the second panel comprising an opening forming a first receptacle for holding a sample collection device; and

(iii) a second receptacle for insertion of the test strip formed by the first panel and the second panel, the insertion occurring during performance of an assay; and

(b) a second opposable component hingedly attached to the first opposable component;

wherein the first and second opposable components are pressed together into operable contact to express fluid from the sample collection device to the inserted test strip thereby applying the sample to the test strip, the test strip comprising at least one assay reagent which reacts with the analyte to produce a detectable signal which indicates the presence or amount of the analyte in the sample, wherein the test strip comprises a chromatographic medium comprising a first end and a second end such that when the test strip is inserted into the second receptacle and when the first and second opposable components are brought into said operable contact, the fluid expressed from the sample collection device is applied to the first end of the chromatographic medium, wherein the chromatographic medium further comprises a detection zone comprising an immobilized specific binding partner for the analyte and wherein the second opposable component further comprises an aperture for viewing of the detection zone.

12. An assay device for use with an insertable test strip for detection or determination of an analyte in a liquid sample, comprising:

(a) a first opposable component comprising;

(i) a first panel; and

(ii) an opening forming a first receptacle for holding a sample collection device in the first panel;

(b) a second opposable component hingly attached to the first panel of the first opposable component, the second opposable component comprising an aperture; and

(c) a third opposable component hingedly attached to the second opposable component, the third opposable component comprising a second receptacle for insertion of the test strip, the insertion occurring during performance of an assay;

wherein the second and third opposable component are foldable and the first and second opposable components are pressed together into operable contact when the second opposable component has been folded over the third opposable component to express fluid through said aperture from the sample collection device to the inserted test strip thereby applying the sample to the test strip, the test strip comprising at least one assay reagent which reacts with the analyte to produce a detectable signal which indicates the presence or amount of the analyte in the sample.

13. The assay device of claim 12 wherein the first receptacle is shaped to hold a swab.

14. The assay device of claim 12 wherein the test strip comprises a chromatographic medium comprising a first end and a second end such that when the test strip is inserted into the second receptacle and the first and second opposable components are brought into said operable contact, the fluid expressed from the sample collection device is applied to the first end of the chromatographic medium.

15. The assay device of claim 14 wherein the chromatographic medium further comprises a detection zone comprising an immobilized specific binding partner for the analyte and the detection zone is visible through the aperture.

16. A test kit comprising, in separately packaged containers:

(a) the assay device of claim 12; and

(b) at least one sample pretreatment or a second assay reagent for application either to the sample collection device or the test strip, respectively.

17. The test kit of claim 16 further comprising said sample collection device, wherein the sample collection device is impregnated with a second sample pretreatment reagent which reacts with said at least one sample pretreatment reagent to form an extraction reagent which extracts the analyte from the sample when the sample is applied to the sample collection device and contacted with the at least one sample pretreatment reagent.

18. The test kit of claim 17 wherein the extraction reagent formed is nitrous acid.

19. The assay for the detection or determination of said analyte comprising the steps of:

(a) providing the assay device of claim 12, the sample collection device, and a test strip, wherein the test strip is covered with a releasable liner by means of an adhesive layer;

(b) collecting the sample on the sample collection device;

(c) inserting the sample collection device with the sample into the first receptacle of the assay device of claim 12;

(d) removing the releasable liner from the test strip of step (a) and inserting the test strip from which the releasable liner has been removed into the second receptacle of the assay device of claim 12;

(e) folding the third opposable component over the second opposable component;

(f) folding the second and third opposable components together over the first opposable component and pressing the sample collection device into said operable contact with the test strip to express the fluid sample the sample collection device to apply the sample to the test strip; and

(g) observing or measuring the presence or amount of the detectable signal produced on the test strip in response to the sample applied to it in order to detect or determine the analyte in the sample.

20. The assay of claim 19 further comprising the step of applying at least one sample pretreatment or a second assay reagent to the sample collection device after inserting the sample collection device into the first receptacle.

21. A test kit comprising, in separately packaged containers:

(a) the assay device of claim 12; and

(b) the test strip for insertion into the second receptacle of the assay device, the test strip being covered with a releasable liner by means of an adhesive layer.

22. An assay device for use with an insertable test strip for detection or determination of an analyte in a liquid sample, comprising:

(a) a first module comprising;

(i) a first panel, the first panel comprising a receptacle for holding a sample collection device;

(ii) a second panel hingedly attached to the first panel, the second panel comprising an aperture for viewing of a portion of the test strip; and

(b) a second module comprising a second receptacle for insertion of the test strip, the insertion occurring during performance of an assay, the second module reversibly hingedly attachable to the second panel of the first module;

wherein, when the second module is attached to the first module, the second module is folded over the second panel of the first module, and the second module and or second panel of the first module are then folded together over the first panel of the first module to press to the second module and the first panel of the first module into operable contact to express fluid from the sample collection device thereby applying the sample to the test strip, the test strip comprising at least one assay reagent which reacts with the analyte to produce a detectable signal which indicates the presence or amount of the analyte in the sample.

23. The assay device of claim 22 wherein the first receptacle is shaped to hold a swab.

24. The assay device of claim 22 wherein the test strip comprises a chromatographic medium comprising a first end and a second end such that when the test strip is inserted into the second receptacle and the first and second components are brought into said operable contact, the fluid expressed from the sample collection device is applied to the first end of the chromatographic medium.

25. The assay device of claim 24 wherein the chromatographic medium comprises a detection zone comprising an immobilized specific binding partner for the analyte and wherein the aperture of the second portion of the first module allows viewing of the detection zone when the second module is folded over the second panel of the first module.

26. A test kit comprising, in separately packaged containers:

(a) the assay device of claim 22; and

(b) at least one sample pretreatment or a second assay reagent for application either to the sample collection device or the test strip, respectively.

27. The test kit of claim 26 further comprising said sample collection device, wherein the sample collection device impregnated with a second sample pretreatment reagent which reacts with said at least one sample pretreatment reagent to form an extraction reagent which extracts the analyte from the sample when the sample is applied to the sample collection device and contacted with the at least one sample pretreatment reagent.

28. The assay for the detection or determination of said analyte comprising the steps of:

(a) providing the assay device of claim 22, the sample collection device and the test strip, wherein the test strip is covered with a releasable liner by means of an adhesive layer, (b) collecting tie sample on the sample collection device;

(c) inserting the sample collection device with the sample into the first receptacle of the first panel of the first module of the assay device of claim 22;

(d) removing the releasable liner from the test strip of step (a) and insert the test strip from which the releasable liner has been removed into the second receptacle of the second module of the assay device of claim 22;

(e) attaching the second module of the assay device with inserted test strip to the second panel of the first module of the assay device;

(f) folding the second module of the assay device over the second panel of the first module of the assay device;

(g) folding the second module and the second panel of the first module of the assay device together over the first panel of the first module of the assay device to place the test strip into said operable contact with the sample collection device to express the fluid from the sample collection device to apply the sample to the test strip; and

(h) observing or measure the presence or amount of the detectable signal produced on the test strip in response to the sample applied to it in order to detect or determine the analyte in the sample.

29. A test kit comprising, in separately packaged containers:

(a) the assay device of claim 22; and

(b) the test strip for insertion into the second receptacle of the assay device, the test strip being covered with a releasable liner by means of an adhesive layer.

30. An assay device for detection or determination of an analyte in a liquid sample comprising:

(a) a first support panel comprising a sample application zone;

(b) a second support panel hingedly attached to the first support panel and comprising an aperture for viewing a test strip, the second support panel comprising fist, second, third and fourth sides with the first and third sides being parallel and the second and fourth sides being parallel, with the first side being hingedly attached to the first support panel,

(c) a third support panel hingedly attached to the third side of the second support panel, the third support panel comprising first and second surfaces with the test strip attached to the second surface, the test strip comprising an immobilized specific binding partner for the analyte;

(d) a first reaction panel hingedly attached to the second side of the second support panel comprising a first reaction pad comprising a resolubilizable first reagent to be applied to a first portion of the test strip, wherein the first reagent is (i) an extraction reagent for releasing the analyte for the sample of (ii) a specific binding partner for the analyte or the analyte, coupled to a label which produces a detectable signal which indicates the presence or amount of the analyte in the sample;

(e) a second reaction panel hingedly attached to the fourth side of the second support panel comprising a second reaction pad comprising a resolubilizable second reagent to be applied to a second portion of the test strip upstream from the first portion, wherein the second reagent is (i) the labeled specific binding partner for the analyte or the labeled analyte, (ii) a reagent which reacts with the label to produce or amplify the detectable signal or (iii) a buffer or salt;

wherein the third support panel is folded over the second support panel and the combination of the second and third support panels is then folded over the first support panel such that the test strip is in operable contact with the sample application zone, and wherein, when the third support panel is folded over the second support panel, the first reaction panel is in operable contact with the first portion of the test strip, and when the second reaction panel is folded over the third support panel, the second reaction pad is in operable contact with the second portion of the test strip.

31. The assay device of claim 30 wherein the test strip comprises a chromatographic medium.

32. The assay device of claim 31 wherein the chromatographic medium comprises first and second ends, the first end comprising the first portion of the test strip and the second end comprising the second portion of the test strip.

33. The assay device of claim 30 wherein the first reagent is said extraction reagent.

34. The assay device of claim 30 wherein the first reagent is said labeled specific binding partner.

35. The assay device of claim 30 wherein the second reagent is said labeled specific binding partner.

36. The assay device of claim 30 wherein the first reagent is an enzyme-labeled specific binding partner for the analyte;

and the second reagent is a substrate which reacts with the enzyme label to produce said detectable signal.

37. The assay device of claim 36 wherein the enzyme label is selected from the group consisting of horseradish peroxidase, β

-galactosidase, glucose oxidase, and alkaline phosphatase.

38. The assay device of claim 30 wherein the first reagent is said labeled specific binding partner and the second reagent is a amplifying reagent.

39. The assay device of claim 38 wherein the labeled specific binding partner is labeled with a gold sol label and the amplifying reagent comprises a quinone and a soluble silver salt.

40. The assay for detecting or determining said analyte in said sample comprising the steps of:

(a) applying the sample to the sample application zone of the assay device of claim 30;

(b) folding the third support panel over the second support panel of the assay device of claim 30 and then folding the combined third and second support panels over the first support panel, pressing the sample application zone into said operable contact with the test strip to apply the sample to the test strip;

(c) unfolding the second and third support panels from the first support panel and refolding the third support panel over the second suppor panel;

(d) folding the first and second reaction panels over the second support panel, pressing the first and second reaction pads into said operable contact with the test strip to resolubilize and apply the first and second reagents to the test strip;

(e) allowing the sample and thc first and second reagents to migrate through at least said first and second portions of the test strip; and

(f) detecting or determining the analyte by observing or measuring the presence or amount of the detectable signal produced by the label specifically bound to said immobilized specific binding partner.

41. An assay device for detection or determination of an analyte in a liquid sample comprising:

(a) a first module comprising;

(i) a first support panel comprising a sample application zone; and

(ii) a second support panel comprising an aperture therein for viewing a test strip and comprising first, second, third and fourth sides with the first and third sides and second and fourth sides being parallel, with the first side of the second support panel being hingedly attached to the first support panel;

(b) a second module comprising a third support panel, the third support panel comprising said test strip, the second module being reversibly hingedly attached to the third side of the second support panel of the first module, the test strip comprising an immobilized specific binding partner for the analyte;

(c) a third module comprising a first reaction panel comprising a first reaction pad, said first reaction panel reversibly hingedly attached to the second side of the second support panel of the first module, the first reaction pad comprising a resolubilizable first reagent to be applied to first portion of the test strip wherein the first reagent is (i) an extraction reagent for releasing the analyte from the sample or (ii) a specific binding partner for the analyte or the analyte, coupled to a label which produces a detectable signal which indicates the presence or amount of the analyte in the sample; and

(d) a fourth module comprising a second reaction panel comprising a second reaction pad, said second reaction panel reversibly hingedly attached to the fourth side of the second support panel of the first module, the second reaction pad comprising a resolubilizable second reagent to be applied to a second portion test strip upstream of the first portion, wherein the second reagent is (i) the labeled specific binding partner for the analyte or the labeled analyte;

(ii) a reagent which reacts with the label to produce or amplify the detectable signal or (iii) a buffer or salt;

wherein the second module is folded over the second support panel of the first module, and the second module and the second support panel of the first module are then folded over the first support panel of the first module the sample application zone is pressed into operable contact with the test strip; and

when the second module is folded over the second support panel of the first module, and the third module is folded over the second support panel of the first module and the second module to press the first reaction pad into said operable contact with the first portion of the test strip to apply the first reagent to the test strip and the fourth module is folded over the second support panel of the first module and the second module to press the second reaction pad into said operable contact with the second portion of the test strip to apply the second reagent to the test strip.

42. The assay device of claim 41 wherein the test strip comprises a chromatographic medium.

43. The assay device of claim 42 wherein the chromatographic medium comprises a first end and second end, the first end comprising the first portion of the test strip and the second end comprising the second portion of the test strip, and the sample application zone is in operable contact with the first end of the chromatographic medium when the second module and the second support panel of the first module are folded to over the first support panel of the first module.

44. The assay device of claim 41 wherein the first reagent is said extraction reagent.

45. The assay device of claim 41 wherein the first reagent is said labeled specific binding partner.

46. The assay deice of claim 41 wherein the second reagent is said labeled specific binding partner.

47. The assay device of claim 41 wherein the first reagent is enzyme-labeled specific binding partner, and the second reagent is a substrate which reacts with the enzyme label to produce said detectable signal.

48. The assay device of claim 47 wherein the enzyme label is selected from the group consisting of horseradish peroxidase, β

-galactosidase, glucose oxidase, and alkaline phosphatase.

49. The assay device of claim 41 wherein the first reagent is said labeled specific binding partner and the second reagent is said amplifying reagent.

50. The assay device of claim 49 wherein the labeled specific binding partner is labeled with a gold sol label and the amplifying reagent comprises a quinone and a silver salt.

51. A test kit comprising, in separately packaged containers:

(a) the assay device of claim 41; and

(b) at least one sample pretreatment reagent for application to any one of either the sample application zone, the first reaction pad, or the second reaction pad, or a second assay reagent for application to any one of either the sample application zone, the first reaction pad, or the second reaction pad.

52. The assay for the detection or determination of said analyte comprising the steps of:

(a) providing the assay device of claim 41;

(b) adding the sample to the sample application zone of the assay device of claim 41;

(c) folding the second module of the assay device over the second support panel of the first module and then folding the combined second module and the second support panel of the first module over the first support panel of the first module, pressing the test strip into operable contact with the sample application zone;

(d) unfolding the second module and the second support panel of the first module from the first support panel of the first module and then folding the third module over the second module, pressing the first reaction pad into said operable contact with the test strip to resolubilize and apply the fist reagent to the test strip and folding the fourth module over the second module, pressing the second reaction pad into said operable contact with the test strip to resolubilize and apply the second reagent to the test strip;

(e) allowing the sample and the first and second reagents to migrate through it least said first and second portions of the test strip; and

(f) observing or measuring the presence or amount of the detectable signal produced by the label specifically bound to said immobilized specific binding partner in order to detect or determine the analyte in the sample.

53. An assay device for use with an insertable test strip for detection or determination of an analyte in a liquid sample, comprising:

(a) a first support panel comprising a sample application zone;

(b) a second support panel hingedly attached to the first support panel and comprising an aperture for viewing of the test strip, the second support panel comprising first, second, third and fourth sides with the first and third sides being parallel and the second and fourth sides being parallel, with the first side being hingedly attached to the first support panel;

(c) a third support panel hingedly attached to the third side of the second support panel, the third support panel comprising first and second surfaces and comprising a receptacle for insertion of the test strip such that, when the test strip is inserted into the receptacle, a surface of the test strip is accessible from the second surface of the third support panel;

(d) a first reaction panel hingedly attached to a second side of the second support panel, the first reaction panel comprising a first reaction pad comprising a resolubilizable first reagent to be applied to a first portion of the test strip, wherein the first reagent is (i) an extraction reagent for releasing the analyte from the sample or (ii) a specific binding partner for the analyte or the analyte, coupled to a label which produces a detectable signal which indicates the presence or amount of the analyte in the sample; and

(e) a second reaction panel hingedly attached to the fourth side of the second support panel, the second action panel comprising a second reaction pad comprising a resolubilizable second reagent applied to a second portion of the test strip upstream from the first portion wherein the second reagent is (i) the labeled specific binding partner for the analyte or the labeled analyte;

(ii) a reagent which reacts with the label to produce or amplify the detectable signal or (iii) a buffer or salt;

wherein the third support panel is folded over the second support panel and the combination of the second and third support panels is then folded over the first support panel, pressing the test strip into operable contact with the sample application zone, and wherein, when the third support panel is folded over the second support panel, the first reaction panel is folded over the third support panel so that the first reaction pad is pressed into operable contact with the first portion of the test strip to apply the first reagent to the test strip and the second reaction panel is folded over the third support panel so that the second reaction is pressed into operable contact with the second portion of the test strip to apply the second reagent to the test strip, the test strip comprising an immobilized specific binding partner for the analyte.

57. The assay device of claim 53 wherein the first reagent is said extraction reagent.

58. The assay device of claim 53 wherein the first reagent is said labeled specific binding partner.

59. The assay device of claim 53 wherein the second reagent is said labeled specific binding partner.

60. The assay device of claim 53 wherein the first reagent is an enzyme-labeled specific binding partner for the analyte, and the second reagent is a substrate which reacts with the enzyme label to produce said detectable signal.

61. The assay device of claim 60 wherein the enzyme label is selected from the group consisting of horseradish peroxidase, β

-galactosidase, glucose oxidase, and alkaline phosphatase.

62. The assay device of claim 53 wherein the first reagent is said labeled specific binding partner and the second reagent is said amplifying reagent.

63. The assay device of claim 53 wherein the labeled specific binding partner is labeled with a gold sol label and the amplifying reagent comprises a quinone and a soluble silver salt.

64. The assay for the detection or determination of said analyte in a test sample comprising the steps of:

(a) providing the assay device of claim 53 and a test strip, wherein the test strip is covered with a releasable liner by means of an adhesive layer;

(b) applying the sample to the sample application zone of the assay device of claim 53;

(c) removing the releasable liner from the test strip of step (a) and inserting the test strip into the receptacle of the assay device of claim 53;

(d) folding the third support panel over the second support panel and then folding the combined third and second support panels over the first support panel, pressing the sample application zone into said operable contact with the test strip to apply the sample to the test strip;

(e) unfolding the second and third support panels from the first support panel and refolding the third support panel over the second support panel;

(f) folding the first and second reaction panels over the second support panel, pressing the first and second reaction panels into said operable contact with the test strip to resolubilize to apply the first and second reagents to the test strip;

(g) allowing the sample and the first and second reagents to migrate through at least said first and second portions of the test strip; and

(h) detecting or determining the analyte by observing or measuring the presence or amount of the detectable signal produced by the label specifically bound to said immobilized specific binding partner.

54. The assay device of 53 wherein the test strip comprises a chromatographic medium comprising a first end, and a second end comprising the first portion of the test strip and the second end comprising the second portion of the test strip.

55. The assay device of claim 54 wherein the chromatographic medium comprises a detection zone, the detection zone comprising an immobilized specific binding partner for the analyte, and wherein the aperture is for viewing of the detection zone.

56. The assay device of claim 54 wherein the first reaction pad is in operable contact with the first end of the chromatographic medium, and the second reaction pad is in operable contact with the second end of the chromatographic medium.

65. An assay device for use with an insertable test strip for detecting or determining an analyte in a liquid sample, comprising:

(a) a first module comprising;

(i) a first support panel comprising a sample application zone; and

(ii) a second support panel comprising an aperture therein for viewing the test strip and comprising first, second, third, and fourth sides with the first and third sides and the second and fourth sides being panel, the second support panel being hingedly attached to the first support panel via the first side of the second support panel;

(b) a second module comprising a third support panel, the third support panel comprising first and second surfaces and comprising a receptacle for insertion of the test strip such that, when the test strip is inserted into the receptacle, a surface of the test strip is accessible from the second surface of the third support panel, the second module being reversibly hingedly attached to the third side of the second support panel of the first module;

(c) a third module comprising a first reaction panel comprising a first reaction pad comprising a resolubilizable first reagent to be applied to a first portion of the test strip, the third module being reversibly hingedly attached to the second side of the second support panel of the first module, wherein the first reagent is (i) an extraction reagent for releasing the analyte from the sample for (ii) a specific binding partner for the analyte or the analyte, coupled to a label which produces a detectable signal which indicates the presence or amount of the analyte in the sample; and

(d) a fourth module comprising a second reaction panel comprising a second reaction pad comprising a second reagent applied to the test strip, the fourth module being reversibly hingedly attached to the second side of the second support panel of the first module, wherein the second reagent is (i) the labeled specific binding partner for the analyte or the labeled analyte;

(ii) a reagent which reacts with the label to produce or amplify the detectable signal or (iii) a buffer or salt;

wherein the second module is folded over the second support panel of the first module, the second module and the second support panel of the first module are then folded over the first support panel of the first module such that the sample application zone is pressed into operable contact with the test strip; and

when the third module is folded over the second support panel of the first module and the second module, and the fourth module is folded over the second support panel of the first module and the second module such that the first reaction pad is pressed into operable contact with the first portion of the test strip to apply the first reagent to first portion of the test strip and such that the second reaction pad is pressed into operable contact with the second portion of the test strip to apply the second reagent to the second portion of the test strip, the test strip comprising reacts with the analyte to produce a detectable signal which indicates the presence or amount of an immobilized specific binding partner for the analyte.

66. The say device of claim 65 wherein the test strip comprises a chromatographic medium comprising a first end and a second end, the first end comprising the first portion of the test strip and the second end comprising the second portion of the test strip.

67. The assay device of claim 66 wherein the chromatographic medium comprises a detection zone, the detection zone comprising the immobilized specific binding partner for the analyte, and wherein the aperture is for viewing of the detection zone.

68. The assay device of claim 66 wherein the first reaction pad is in operable contact with the first end of the chromatographic medium and the second reaction pad is in operable contact with the second end of the chromatographic medium.

69. The assay device of claim 65 wherein the first reagent is said extraction reagent.

70. The assay device of claim 65 wherein the first reagent is said labeled specific binding partner.

71. The assay device of claim 65 wherein the second reagent is said labeled specific binding partner.

72. The assay device of claim 65 wherein the first reagent is an enzyme-labeled specific binding partner for the analyte, and the second reagent is a substrate which reacts with the enzyme label to produce said detectable signal.

73. The assay device of claim 72 wherein the enzyme label is selected from the group consisting of horseradish peroxidase, β

-galactosidase, glucose oxidase, and alkaline phosphatase.

74. The assay device of claim 65 wherein the first reagent is said labeled specific binding partner and the second reagent is said amplifying reagent.

75. The assay device of claim 74 wherein the labeled specific binding partner is labeled with a gold sol label and the amplifying reagent comprises a quinone and a soluble silver salt.

76. The assay for the detection or the determination of said analyte in a test sample comprising the steps of:

(a) providing the assay device of claim 65 and the test strip, wherein the test strip is covered with a releasable liner by means of an adhesive layer;

(b) adding the sample to the sample application zone of the assay device of claim 65;

(c) removing the releasable liner from the test strip of step (a) and inserting the test strip from which the releasable liner has been removed into the receptacle of the assay device of claim 65;

(d) folding the second module of the assay device over the second support panel of the first module and then folding the combined second module and the second support panel of the first module over the first support panel of the first module, pressing the test strip into said operable contact with the sample application zone;

(e) unfolding the second module and the second support panel of the first module from the first support panel of the first module and then folding the third module over the second module, pressing the first reaction pad into said operable contact with the test strip to resolubilize and apply the first reagent to the test strip and folding the fourth module over the second module to press the second reaction pad into said operable contact with the test strip to resolubilize and apply the second reagent to the test strip;

(f) allowing the sample and the first and second reagents to migrate through said first and second portions of the test strip; and

(g) observing or measuring the presence or amount of the detectable signal produced by the label specifically bound to said immobilized specific binding partner to detect or determine the analyte in the sample.

77. An assay device for use with an insertable test strip for detection or determination of an analyte in a sample comprising:

(a) a first opposable component comprising;

(i) a first panel;

(ii) a second panel mounted on the first panel parallel to the first panel with space between the first and the second panel, the second panel comprising an opening forming a first receptacle for holding a sample collection device; and

(iii) a second receptacle for insertion of the test strip formed by the first panel and the second panel, the insertion occurring during performance of an assay, the second receptacle comprising slidable contact means to hold the test strip slidably in one of two positions, a first position in which the test strip is in operable contact with the sample collection device placed in the first receptacle and a second position in which the test strip is not in operable contact with the sample collection device; and

(b) a second opposable component hingedly attached to the first opposable component;

wherein the first and second opposable components are pressed together into operable contact to express fluid from the sample collection device to the inserted test strip thereby applying the sample to the test strip for the detection or determination of the analyte, the test strip comprising at least one assay reagent which react with the analyte to produce a detectable signal which indicates the presence or amount of the analyte in the sample.

78. The assay device of claim 77 wherein the first receptacle is shaped to hold a swab.

79. The assay device of claim 77 wherein the test strip comprises a chromatographic medium comprising a first end and a second end such that the test strip is inserted into the second receptacle and when the first and second opposable components are pressed into said operable contact, the fluid expressed from the sample collection device is applied to the first end of the chromatographic medium.

80. The assay device of claim 77 wherein the second opposable component comprises an aperture for viewing of at least a portion of the test strip.

81. The assay device of claim 79 wherein the chromatographic medium comprises a detection zone, the detection zone comprising an immobilized specific binding partner for the analyte, and wherein the second opposable component further comprises an aperture for viewing of the detection zone.

82. A test kit comprising, in separately packaged containers:

(a) the assay device of claim 77; and

(b) at least one sample pretreatment or a second assay reagent for application either to the sample collection device or the test strip, respectively.

83. The test kit of claim 82 further comprising said sample collection device, wherein the sample collection device is impregnated with a second sample pretreatment reagent to form an extraction reagent which extracts the analyte from the sample when the sample is applied to the sample collection device and contacted with the at least one sample pretreatment reagent.

84. The test kit of claim 83 wherein the extraction reagent formed is nitrous acid.

85. The assay for the detection or determination of said analyte in a sample comprising the steps of:

(a) providing the assay device of claim 77, the sample collection device, and the test strip, wherein the test strip is covered with a releasable liner by means of an adhesive layer;

b) collecting the sample on the sample collection device;

(c) inserting the test strip of step (a) into the second receptacle of the assay device of claim 77;

(d) moving the test strip inserted into the second receptacle of the assay device of claim 77 to the second position;

(e) inserting the sample collection device with the sample into the first receptacle of the assay device of claim 77;

(f) returning the test strip to the first position;

(g) pressing the first and second opposable components of the assay device into said operable contact to express the fluid from the sample collection device to apply the sample to the test strip; and

(h) observing or measuring the presence or amount of the detectable signal produced on the test strip in response to the sample applied to it in order to detect or determine the analyte in the sample.