Immunoassay test device and method of use

• US 20080081341A1
• Filed: 10/03/2006
• Published: 04/03/2008
• Est. Priority Date: 10/03/2006
• Status: Active Grant

• Current Assignee: Meridian Bioscience, Inc.
• Original Assignee: Meridian Bioscience, Inc.
• Inventors: Kraft, Jeffrey A., Kozak, Kenneth J., Maher, Jonathan Scott
• Granted Patent: US 7,749,775 B2
• Time in Patent Office: Days
• US Class Current: 435/7.1
• CPC Class Codes: B01L 2300/043 Hinged closures
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 9/52 Supports specially adapted for flat sample carriers, e.g. for plates, slides, chips
• CPC Class Codes: G01N 2333/11 Orthomyxoviridae, e.g. influenza virus
• 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: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/808 Automated or kit
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10T 436/112499 with sample on test slide

Abstract

Disclosed is a diagnostic testing device that may be used to detect one or more analytes in a sample. The device comprises a receptacle and a holder for a test strip. The test strip may be, for example, a lateral flow test strip. The device and holder permit analysis of a sample, wherein the device is substantially sealed during testing and detection of results. To use, the holder containing a test strip is inserted into the receptacle containing sample to be analyzed. Capillary flow along the test strip is initiated by contact of the sample with the distal end of the test strip. The receptacle is such that results of the assay may be detected visually or using standard instrumentation such as by measuring light absorption or reflectance.

Claims

1. A testing device comprising

a) a receptacle with an open and a closed end,

b) a holder, and

c) a test strip, wherein the holder is comprised of an elongated portion for affixing the test strip to said holder, a closure that substantially seals the open end of said receptacle, and a grip member that extends from the open end of said receptacle when the holder is inserted in the receptacle.

2. A device according to claim 1 wherein the holder further comprises a stop feature.

3. A device according to claim 1 wherein the holder further comprises at least one alignment feature.

4. A device according to claim 1 wherein the holder further has one or more retention members.

5. A device according to claim 1, wherein the holder is comprised of two separate complementary, attachable parts that are attached to one another to form the grip member.

6. A device according to claim 1 wherein the holder further comprises a hinge separating a top portion and a lower portion of a grip member, wherein the grip member is formed by folding the top portion of the grip member upon the lower portion of the grip member at said hinge.

7. A device according to claim 1, wherein the holder further comprises at least one shield region along its length.

8. A device according to claim 1 wherein the holder further comprises one or more detection guides.

9. A device according to claim 1 wherein the holder further comprises one or more secondary pins.

10. A device according to claim 1 wherein the test strip is a lateral flow test strip.

11. A device according to claim 10 wherein the test strip further comprises a diffusively mobilized labeling reagent.

12. A device according to claim 1 wherein the receptacle contains a label conjugated to at least one binding reagent.

13. A device according to claim 12 wherein the label is selected from the group consisting of enzymes, radioisotopes, fluorescent tags, carbon particles, beads, and metal sols.

14. A device according to claim 12 wherein the labeling reagent is a lyophilized sphere.

15. A device according to claim 12 wherein the labeling reagent is lyophilized on a pad and placed in the receptacle.

16. A device according to claim 1 wherein the receptacle is selected from the group consisting of test tubes, square cuvettes, triangular cuvettes, transparent test tubes, transparent cuvettes, opaque test tubes, and opaque cuvettes.

17. A device according to claim 1 wherein the receptacle has one or more viewing windows.

18. A device according to claim 1 wherein the receptacle is curved in such a manner as to allow magnification of its contents.

19. A device according to claim 1 wherein the test strip is a lateral flow test strip comprising an immobilized second binding reagent specific for influenza A, an immobilized second binding reagent specific for influenza B, and a control region.

20. A holder for a test strip comprising an elongated portion and a grip member, wherein the holder is formed by folding at a living hinge, wherein the test strip is affixed to the elongated portion.

21. A holder according to claim 20 wherein the holder further comprises a stop feature.

22. A holder according to claim 20 wherein the holder further comprises an alignment feature.

23. A holder according to claim 20 wherein the holder further comprises at least one shield region along its length.

24. A holder according to claim 20, which further comprises a retention member.

25. A holder according to claim 20, which further comprises one or more detection guides.

26. A holder according to claim 20, which further comprises one or more secondary pins.

27. A test device comprising:

a) a test-tube like receptacle having an open end and a closed end containing a labeling reagent capable of binding with an analyte,

b) a test strip comprising a first absorbent pad, a membrane strip and a second absorbent pad defining a flow path for transporting a liquid sample,

c) the test strip comprising at least one test site further comprising an immobilized second binding reagent,

d) the test strip being recessed within a holder, wherein the holder is further comprised of an elongated support having a recess, a closure that substantially seals the open end of said receptacle, a stop feature and a grip member that extends from the open end of said receptacle when the holder is inserted into the receptacle,

e) the holder being formed by folding the top portion of the grip member upon the lower portion of the grip member at a hinge such that one edge of the folded portion captures the second absorbent pad;

f) wherein said holder, after being folded, comprises the grip member, the closure and the stop feature.

28. A test device according to claim 27, wherein the labeling reagent comprises a detectable label and a first binding reagent that binds to Influenza A.

29. A test device according to claim 27, wherein the labeling reagent comprises a detectable label and a first binding reagent that binds to Influenza B.

30. A test device according to claim 27 wherein the labeling reagent is conjugated to a pad.

31. A test device according to claim 27 wherein the labeling reagent is a lyophilized sphere.

32. A test device according to claim 27, wherein the test strip further comprises a control region.

33. A test device according to claim 27 wherein the test strip is comprised of a first absorbent pad, a nitrocellulose membrane having a plastic backing and a second absorbent pad, having immobilized second binding reagents impregnated therein.

34. A kit for detecting the presence of an analyte in a sample, said kit comprising a) a receptacle;

b) a holder for a test strip comprising an elongated portion, an alignment feature, a closure that substantially seals the receptacle, one or more detection guides, and a grip member; and

c) a test strip wherein said test strip is attached to the elongated portion and the holder is configured to fit into the receptacle.

35. A kit according to claim 34, wherein the receptacle contains a pre-dispensed labeling reagent.

36. A kit according to claim 34, wherein the kit further comprises a diluent.

37. A method of detecting an analyte in a sample, comprising the steps of

a) providing a receptacle with an open end and a closed end containing a labeling reagent comprised of a label and at least one binding reagent;

b) dispensing a diluent into the receptacle;

c) introducing into the receptacle a sample suspected of containing the analyte d) forming a mixture comprising labeling reagent, sample and diluent;

e) contacting the mixture with a test strip;

f) wherein the test strip is affixed to a holder comprising an elongated portion, a closure that substantially seals the receptacle, and a grip member which extends from the open end of said receptacle when the holder is inserted into the receptacle;

g) permitting lateral flow of the mixture by capillary action along the test strip such that the mixture contacts at least one second binding reagent immobilized on the test strip; and

h) detecting a result.

38. A method according to claim 37, wherein the labeling reagent is a lyophilized sphere.

39. A method according to claim 37, wherein the analytes to be detected are one or more analytes selected from the group consisting of influenza A and influenza B.