Assay device and use thereof

• US 6,812,038 B1
• Filed: 11/15/2000
• Issued: 11/02/2004
• Est. Priority Date: 11/18/1999
• Status: Expired due to Term

• Current Assignee: Phadia AB (Thermo Fisher Scientific Incorporated)
• Original Assignee: Phadia AB (Thermo Fisher Scientific Incorporated)
• Inventors: Björkman, Rune, Mendel-Hartvig, Ib
• Primary Examiner(s): Chin, Christopher L.
• Application Number:
  US09/713,763
• Time in Patent Office: 1,448 Days
• Field of Search: 422/55-58, 422/61, 435/7.9, 435/7.92, 435/287.1, 435/287.2, 435/287.7, 435/287.9, 435/288.4, 435/288.5, 435/288.7, 435/805, 435/810, 435/970, 435/975, 436/169, 436/172, 436/514, 436/518, 436/525, 436/530, 436/805, 436/810, 436/808
• US Class Current: 436/514
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• 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 435/81 Packaged device or kit
• 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 436/808 Automated or kit
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

A test device and a kit for conducting an assay for the determination of an analyte in a sample comprises (i) a housing (1,2), and within said housing, (ii) a flow matrix (6) allowing liquid to be transported by capillary action and having at least one zone with immobilized capturing agent capable of directly or indirectly binding to the analyte, (iii) a liquid container (13) for sample liquid, and (iv) at least one liquid container for liquid other than sample liquid. The device further comprises (v) separation means (5) between the flow matrix (6) and the liquid containers (13), wherein said separation means (5) are mounted in movable relationship with the liquid containers to in a first position prevent liquid contact of the flow matrix (6) with the liquid containers (13), and in a second position permit liquid receiving contact of the flow matrix (6) with the liquid containers (13).

An assay method for determining an analyte in a sample wherein the sample and assay liquids are flown through a flow matrix to reach the reaction zone in a predetermined sequence uses the device for carrying out the method. The use of the device comprises testing for a allergy, inflammation or autoimmune disease.

Claims

1. A test device for conducting an assay for the determination of an analyte in a sample, the test device comprising (i) a housing, and within said housing, (ii) a flow matrix allowing liquid to be transported by capillary action and having at least one zone with immobilized capturing agent capable of directly or indirectly binding to the analyte, (iii) a liquid container for sample liquid, (iv) at least one liquid container for liquid other than sample liquid in the form of an absorbent pad or sponge, and (v) separation means between the flow matrix and the liquid containers, wherein said separation means are mounted in a movable relationship with the liquid containers between a first position wherein the separation means prevent liquid contact of the flow matrix with the liquid containers, and a second position wherein the separation means permit liquid receiving contact of the flow matrix with the liquid containers.

2. The test device according to claim 1, wherein the flow matrix is flat and the liquid flow is lateral within said matrix.

3. The test device according to claim 1 wherein the flow matrix is a membrane strip.

4. The test device according to claim 2 wherein the liquid containers are mounted adjacent to a face of said flow matrix, and the separation means comprise a flat liquid-tight element sandwiched between the liquid containers and the flow matrix.

5. The test device according to claim 4, wherein the liquid-tight element is at least partially removable from the housing.

6. The test device according to claim 5, wherein the liquid-tight element is a pull-out element.

7. The test device according to claim 1, wherein the liquid containers are mounted in a movable relationship with the flow matrix.

8. The test device according to claim 1, wherein the at least one liquid container for liquid other than sample liquid comprises at least one container with flow liquid.

9. The test device according to claim 1, wherein the at least one liquid container for liquid other than sample liquid comprises a container for an analytically detectable reagent.

10. The device according to claim 9, wherein at least one liquid container for flow liquid is provided upstream and/or downstream of said container with analytically detectable reagent.

11. The test device according to claim 1, wherein the flow matrix comprises a zone having an analytically detectable reagent predeposited in the matrix or in an element placed on the matrix.

12. The test device according to claim 11, wherein the at least one container for liquid other than sample liquid comprises a first container for flow liquid provided above and along said zone with analytically detectable reagent.

13. The test device according to claim 12, wherein at least one second container for flow liquid is provided upstream of said first container, and/or at least one third container is provided downstream of said first container.

14. The test device according to claim 11, wherein the at least one container for liquid other than sample liquid comprises a first container for flow liquid extending both upstream of and at least partially above and along said zone with analytically detectable reagent.

15. The test device according to claim 12, wherein at least one second container for flow liquid is provided downstream of said first container.

16. The test device according to claim 14 wherein a barrier element extends above said zone with analytically detectable reagent to prevent direct contact between said first container for flow liquid and the zone with analytically detectable reagent, when said separation means is in said second position.

17. The test device according to claim 1, wherein the capturing agent immobilized in the flow matrix is a member of a specific binding pair and wherein the other member of the specific binding pair is part of or coupled to a reagent capable of binding the analyte.

18. The test device according to claim 17, wherein the said specific binding pair is antigen-antibody, hapten-antibody, biotin-avidin, biotin-streptavidin or a nucleic acid duplex.

19. The test device according to claim 9, wherein the analytically detectable reagent is labelled.

20. The test device of claim 5, wherein the liquid-tight element comprises a pull-out sheet or a film.

21. The test device of claim 8, wherein the flow liquid comprises a buffer solution.

22. The test device of claim 19, wherein the analytically detectable reagent is labelled by a fluorophore or a chromophore.

23. The test device of claim 1, wherein the flow matrix is continuous.

24. A method of performing an assay for determining an analyte in a sample, which method comprises flowing sample and assay liquids through a test device according to claim 1, wherein the sample and assay liquids flow through the flow matrix to reach the zone in said flow matrix in a predetermined sequence, and detecting analyte bound in the zone.

25. The method according to claim 24 for testing for an analyte indicating a disease selected from allergy, inflammation and autoimmune diseases.

26. The method according to claim 25 wherein the analyte is a specific immunoglobulin.

27. A kit for conducting an assay method, which kit comprises a plurality of the test devices.