Lateral flow immunoassay device and method

• US 20060275922A1
• Filed: 08/14/2006
• Published: 12/07/2006
• Est. Priority Date: 10/28/2003
• Status: Active Grant

• Current Assignee: Healgen Scientific, LLC (Zhejiang Orient Gene Biotech Co., Ltd.)
• Original Assignee: Martin Gould, Robert Bernstine, Yli Remo Vallejo
• Inventors: Gould, Martin, Vallejo, Yli Remo, Bernstine, Robert
• Granted Patent: US 7,713,475 B2
• Time in Patent Office: Days
• US Class Current: 436/514
• CPC Class Codes: B01L 2200/026 Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/5029 using swabs
• CPC Class Codes: G01N 33/54389 with bidirectional or multidirectional lateral flow, e.g. wherein the sample flows from a single, common sample application point into multiple strips, lanes or zones
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10T 436/25 including sample preparation

Abstract

A lateral flow immunoassay test device is provided that includes a housing with an elongated slot for holding a test sample collector; an elongated holder member for securing at least one immunoassay test strip therein; a first chamber for storing a first, pre-treatment reagent; and a second chamber for storing a second reagent. Methods of conducting lateral flow immunoassays are also provided. The device and methods of conducting lateral flow immunoassays as provided herein are advantageous in that they allow pre-treatment and pre-incubation of the test sample so that the sample flows onto the test strip more easily and provide for increases in the sensitivity of the assay.

Claims

1. A method of conducting a lateral flow immunoassay comprising:

providing a housing including means for holding a test sample collector with a test sample contained within said collector;

an elongated holder member securing at least one immunoassay test strip therein;

a first chamber containing a first, pre-treatment reagent; and

a second chamber containing a second reagent;

contacting the test sample with said pre-treatment reagent and allowing said test sample to mix with said first reagent and to form a mixture;

combining said second reagent with said mixture in the second chamber and allowing said mixture to react with said second reagent for a period of time prior to contacting the mixture and second reagent combination with at least one immunoassay test strip; and

allowing the mixture and second reagent combination to contact said at least one immunoassay test strip.

2. The method of claim 1 wherein said elongated holder member is held at a position spaced apart from the second chamber until said elongated holder member is activated.

3. The method of claim 1 wherein said pre-treatment reagent includes a buffer solution.

4. The method of claim 1 wherein said second reagent is a binder.

5. The method of claim 4 wherein said binder is a colloid gold-antibody complex.

6. The method of claim 1 wherein said second reagent is an antigen.

7. The method of claim 1 wherein said pre-treatment reagent is contained within a rupturable enclosure.

8. The method of claim 7 wherein said test sample is contacted with said pre-treatment reagent by means of a piercing member that ruptures said enclosure and releases said first reagent therefrom, the test sample being in fluid communication with said first reagent when the test sample is released from the sample collector.

9. The method of claim 1 wherein the step of combining of the mixture with the second reagent is facilitated by providing apertures in communication with said second chamber through which said mixture flows and contacts said second reagent.

10. The method of claim 1 wherein said elongated holder member prevents the test strip from contacting the mixture and second reagent combination until activated.

11. The method of claim 1 wherein said means for holding the test sample collector includes an elongated slot.

12. The method of claim 1 wherein said test sample is contacted with said first pre-treatment reagent by means of a button and a piercing member, said button activating said piercing member to rupture said enclosure and release said first reagent contained therein, the test sample being in fluid communication with said first reagent when the test sample is released from the sample collector.

13. The method of claim 1 wherein said housing is generally L-shaped with a vertical leg having a top end and a bottom end and a horizontal leg extending outwardly from said bottom of said vertical leg.

14. The method of claim 13 wherein said test strip is located within said vertical leg.

15. The method of claim 1 wherein the pre-treatment reagent dilutes or denatures interferants in the test sample.

16. A method of conducting a lateral flow immunoassay comprising:

providing a housing including means for holding a test sample collector with a test sample contained therein;

an elongated holder member for securing at least one immunoassay test strip therein;

a first chamber containing a first reagent; and

a second chamber containing a second reagent;

providing a means for permitting said test sample, said test strip, said first reagent, and said second reagent to be in fluid communication;

and permitting the test sample, the first reagent and the second reagent to form a mixture, and then contacting the mixture of the first reagent, second reagent and test sample with a test strip;

17. The method of claim 16 wherein the elongated holder member is held at a position spaced apart from the second chamber until said elongated holder member is activated;

18. The method of claim 16 wherein said first reagent is contained in a rupturable enclosure.

19. The method of claim 16 wherein said first reagent includes a buffer solution.

20. The method of claim 16 wherein said second reagent is a binder.

21. The method of claim 20 wherein said binder is a colloidal gold-antibody complex.

22. The method of claim 16 wherein said second reagent is an antigen.

23. The method of claim 16 wherein said the test sample, the first reagent and the second reagent mix in said second chamber.

24. The method of claim 16 wherein said test sample is contacted with said first reagent by means of a piercing member that ruptures said enclosure and releases said first reagent therefrom, the test sample being in fluid communication with said first reagent when the test sample is released from the sample collector.

25. The method of claim 16 wherein the first reagent and second reagent are mixed by providing apertures in communication with said second chamber through which said first reagent flows and contacts said second reagent.

26. The method of claim 16 wherein said means for holding the test sample collector includes an elongated slot.

27. The method of claim 16 wherein the test sample and the first reagent are mixed by means of a button and a piercing member, said button activating said piercing member to rupture said enclosure and to release said first reagent contained therein, the test sample being in fluid connection with said first reagent when the test sample is released from the sample collector.

28. The method of claim 16 wherein said housing is generally L-shaped with a vertical leg having a top end and a bottom end and a horizontal leg extending outwardly from said bottom of said vertical leg.

29. The method of claim 28 wherein said test strip is located within said vertical leg.

30. The method of claim 16 wherein the first reagent dilutes or denatures interferants in the test sample.