Solid phase assay employing capillary flow

• US 4,855,240 A
• Filed: 05/13/1987
• Issued: 08/08/1989
• Est. Priority Date: 05/13/1987
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Rosenstein, Robert W., Bloomster, Timothy G.
• Primary Examiner(s): Nucker, Christine M.
• Application Number:
  US07/049,328
• Time in Patent Office: 818 Days
• Field of Search: 422/56, 422/58, 436/514, 436/518, 436/530, 436/807, 436/535
• US Class Current: 436/514
• CPC Class Codes: G01N 30/90 Plate chromatography, e.g. thin layer or paper chromatography
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures

Abstract

Test device and assay for determining analyte wherein tracer and sample may be simultaneously applied to different absorbent material portions both in capillary flow communication with an absorbent material portion having a binder supported thereon in a manner whereby sample contacts binder, prior to any substantial contact between sample and tracer or tracer and binder.

Claims

1. An assay for determining analyte in a sample, comprising:

employing a absorbent solid support having first, second and third portions, said first portion receiving a sample to be assayed, said second portion receiving a tracer, said third portion including a binder for the analyte, said third portion being in capillary flow communication with both the first and second portions;

moving tracer and sample by capillary flow across the binder in the third portion to provide contact between sample and binder prior to substantial contact of the tracer with either the binder or sample; and

determining at least one of tracer bound in said third portion or tracer which passes across said third portion to thereby determine analyte.

2. The assay of claim 1 wherein tracer is added to the second portion of the support during the assay.

3. The assay of claim 1 wherein tracer is present on the second portion of the support prior to the assay.

4. The assay of claim 1 wherein the tracer is comprised of a ligand and a particulate label.

5. The assay of claim 4 wherein the particulate label is a liposome including a colored substance.

6. The assay of claim 5 wherein the tracer and sample move by capillary flow to the third portion through separate and distinct flow paths.

7. The assay of claim 6 wherein the binder is supported on nitrocellulose.

8. The assay of claim 6 wherein the binder is supported on a porous material in the third portion of said support, said porous material supporting the binder in a concentration of at least 1 μ

g/cm².

9. The assay of claim 8 wherein the ligand portion of the tracer is bound by analyte.

10. The assay of claim 8 wherein the first, second and third portions are substantially in the same plane.

11. The assay of claim 1 wherein said solid support is a strip.

12. The assay of claim 11 wherein said strip is formed from separate pieces of absorbent material.

13. The assay of claim 1 wherein said solid support includes a blocking agent to retard the flow of tracer from the second portion to the third portion.

14. The assay of claim 1 wherein in the direction of flow said first portion is closer to the third portion than said second portion.

15. The assay of claim 1 wherein said first, second and third portions are in substantially the same plane.

16. An article of manufacture for determining analyte, comprising:

a solid support having first, second and third portions, said first portion for receiving a sample to be assayed, said second portion for receiving a tracer, said third portion including a binder for the analyte, said third portion being in capillary flow communication with both the first and second portions whereby sample and tracer flow across the binder in the third portion to provide contact between sample and binder prior to substantial contact of the tracer with either the binder or sample, said solid support being an absorbent material which provides for capillary flow.

17. The article of claim 16 wherein the first absorbent material portion defines a first flow path for capillary flow between the sample receiving portion and the third portion including the binder, and the second absorbent material portion defines a second flow path for capillary flow between the tracer receiving portion and the third portion including the binder.

18. The article of claim 17 wherein the flow path between the sample receiving portion and the third portion is shorter than the flow path between the tracer receiving portion and the third portion.

19. The article of claim 17 wherein the second absorbent material portion is treated with an agent to inhibit wetting thereof to reduce the rate of flow between the tracer receiving portion and third portion.

20. The article of claim 17 wherein the support includes an absorbent material in contact with the third portion to receive and store any sample and tracer which flows through the third portion.

21. The article of claim 17 wherein the support is a test card having a top portion and a bottom portion, the first, second and third absorbent material portions being between the top and bottom portions of the test card, said top portion including a first port over the sample receiving portion of the first absorbent material portion for application of sample thereto, a second port over the tracer receiving portion of the second absorbent material portion for application of tracer thereto, and a viewing port over the binder portion of the third absorbent material portiton to view tracer during an assay.

22. The article of claim 21 wherein the first, second and third absorbent material portions are in substantially the same plane.

23. The article of claim 17 wherein binder is supported in the third portion in a concentration of at least 1ug/cm².

24. The article of claim 16 wherein the first, second and third portions are in substantially the same plane.