TEST DEVICE FOR MEMBRANE ASSAY COMPRISING REFERENCE DISPLAY SECTION

• US 20110143458A1
• Filed: 08/21/2009
• Published: 06/16/2011
• Est. Priority Date: 08/22/2008
• Status: Abandoned Application

• Current Assignee: Denka Seiken Co., Ltd. (Denka Company Limited)
• Original Assignee: Denka Seiken Co., Ltd. (Denka Company Limited)
• Inventors: Maegawa, Tsuneo
• Application Number:
  US13/059,608
• Publication Number:
  US 20110143458A1
• Time in Patent Office: Days
• US Class Current: 436/518
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/54391 based on vertical flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387

Abstract

A test device provided with a reference display section that rapidly and clearly indicates proper test completion with improved accuracy and stability is provided. Such test device is a test device for membrane assay using a specific binding reaction of a substance to be detected with a capture reagent immobilized on a membrane carrier and a reagent labeled with a labeling substance, which comprises a reference display section for indicating proper test completion on which a cationic polymer for capturing a labeled reagent has been immobilized.

Claims

1. A test device for membrane assay using a specific binding reaction of a substance to be detected with a capture reagent immobilized on a membrane carrier and a reagent labeled with a labeling substance, which comprises a reference display section for indicating proper test completion on which a cationic polymer for capturing a labeled reagent has been immobilized.

2. The test device according to claim 1, wherein the reference display section is configured by allowing a membrane carrier to absorb a cationic polymer and drying the membrane.

3. The test device according to claim 1, wherein the specific binding reaction is an antigen-antibody reaction

4. The test device according to claim 1, wherein the cationic polymer is a polymer compound having amino groups or imino groups on the main chain or side chain, a cation charge density of 0.4 meq/g to 21 meq/g, and an average molecular weight of 300 to 5,000,000.

5. The test device according to claim 1, wherein the cationic polymer is polyethylenimine, polyallylamine, or a derivative thereof.

6. The test device according to claim 1, which is a lateral-flow-type test device.

7. The test device according to claim 6, wherein the reference display section for indicating proper test completion is configured such that it is positioned downstream of a detection display section on which a capture reagent has been immobilized.

8. The test device according to claim 1, which is a flow-through-type test device.

9. The test device according to claim 8, wherein the reference display section for indicating proper test completion is configured such that it is provided on the plane on which the detection display section on which a capture reagent has been immobilized is located.

10. A method for confirming the proper completion of a test for membrane assay using a specific binding reaction of a substance to be detected with a capture reagent immobilized on a membrane carrier and a reagent labeled with a labeling substance, whereby proper test completion can be confirmed when labeling of a labeled reagent is detected in a reference display section on a membrane by allowing the labeled reagent to bind to a cationic polymer immobilized in the reference display section.

11. The method according to claim 10, wherein the specific binding reaction is an antigen-antibody reaction.

12. The method according to claim 10, wherein the cationic polymer is a polymer compound having amino groups or imino groups on the main chain or side chain, a cation charge density of 0.4 meq/g to 21 meq/g, and an average molecular weight of 300 to 5,000,000.

13. The method according to claim 10, wherein the cationic polymer is polyethylenimine, polyallylamine, or a derivative thereof.