Bidirectional lateral flow test strip and method

• US 7,229,839 B2
• Filed: 01/17/2003
• Issued: 06/12/2007
• Est. Priority Date: 06/14/1999
• Status: Expired due to Term

• Current Assignee: Relia Biotechnologies (Shenzhen) Ltd.
• Original Assignee: Relia Diagnostic Systems Inc.
• Inventors: Polito, Alan J., Dinello, Robert K., Wieck, Henry J., Sierra, George H., Thayer, Richard M.
• Primary Examiner(s): NGUYEN, BAO THUY L
• Application Number:
  US10/346,683
• Publication Number:
  US 20030157729A1
• Time in Patent Office: 1,607 Days
• Field of Search: 436/518, 436/164, 436/165, 436/169, 436/514, 436/528, 436/530, 436/805, 436/807, 436/808, 436/810, 436/811, 436/817, 435/287.6, 435/970, 435/810, 435/974, 435/975
• US Class Current: 436/518
• 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: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 435/974 Aids related test
• CPC Class Codes: Y10S 435/975 Kit
• CPC Class Codes: Y10S 436/805 Optical property
• 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 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10S 436/811 Test for named disease, body condition or organ function
• CPC Class Codes: Y10S 436/817 Steroids or hormones

Abstract

A test strip adapted to receive a sample and detect an analyte therein is provided. The test strip comprises a sample addition zone to which a sample may be added; an absorbent zone proximal to the sample addition zone; one or more test zones distal to the sample addition zone, at least one of the test zones including a first analyte binding agent immobilized therein which is capable of binding to the analyte to be detected; and a terminal sample flow zone distal to the one or more test zones, the absorbent zone being positioned relative to the sample addition zone and having an absorption capacity relative to the other zones of the test strip such that a distal diffusion front of a sample added to the sample addition zone diffuses from the sample addition zone to a distal diffusion point within the terminal sample flow zone and then reverses direction and diffuses proximal relative to the one or more test zones.

Claims

1. A test strip adapted to receive a sample and detect an analyte therein, the test strip comprising:

a sample addition zone to which a sample may be added;

an absorbent zone positioned in a first flow direction relative to the sample addition zone;

one or more test zones positioned in a second, different, flow direction relative to the sample addition zone, at least one of the test zones including a first analyte binding agent immobilized therein which is capable of binding to the analyte to be detected; and

a terminal sample flow zone positioned in the second flow direction relative to the sample addition zone and distal to the one or more test zones,

the absorbent zone having an absorption capacity relative to the other zones of the test strip such that when a sample is added to the sample addition zone, the sample initially diffuses from the sample addition zone both in the first flow direction to the absorbent zone and in the second flow direction past the one or more test zones to a distal diffusion point within the terminal sample flow zone and then reverses flow, and diffuses in the first flow direction past the one or more test zones toward the absorbent zone.

2. The test strip according to claim 1 wherein the test strip is adapted to receive a sample within a predetermined volume range between about 10 and 250 μ

L.

3. The test strip according to claim 1 wherein the test strip is adapted to receive a sample within a predetermined volume range between about 20 and 100 μ

L.

4. The test strip according to claim 1 wherein the test strip is adapted to receive a sample within a predetermined volume range between about 30 and 50 μ

L.

5. The test strip according to claim 1 wherein the terminal sample flow zone has a length from a proximal end to a distal end of between about 3 and 10 mm.

6. The test strip according to claim 1 wherein the first analyte binding agent does not bind to components in the sample other than the analyte.

7. The test strip according to claim 1 wherein the first analyte binding agent is selected from the group consisting of antibodies, engineered proteins, peptides, haptens, lysates containing heterogeneous mixtures of antigens having analyte binding sites, ligands and receptors.

8. The test strip according to claim 1 wherein the test zones further include at least a first control zone with a control binding agent immobilized therein.

9. The test strip according to claim 1 wherein the test zones further include a first control zone with a control binding agent immobilized therein, and a second control zone with a same control binding agent immobilized therein as the first control zone, the first and second control zones containing a different amount of the control binding agent immobilized therein.

10. The test strip according to claim 1 wherein the test strip further includes a zone distal to the terminal sample flow zone which includes a second analyte binding agent which is capable of binding to the analyte and diffusing to the one or more test zones.

11. The test strip according to claim 10 wherein the second analyte binding agent is capable of binding to components in the sample other than the analyte.

12. The test strip according to claim 10 wherein the second analyte binding agent does not bind to components in the sample other than the analyte.

13. The test strip according to claim 10 wherein the second analyte binding agent is labeled with a detectable marker.

14. The test strip according to claim 10 wherein the second analyte binding agent is attached to a particle which is capable of diffusing to the one or more test zones.

15. The test strip of claim 1, wherein the test strip comprises a sample pad in the sample addition zone and a double-sided adhesive between the sample pad and the test strip.