Lateral flow immunoassay device

• US 7,090,803 B1
• Filed: 10/28/2003
• Issued: 08/15/2006
• Est. Priority Date: 10/28/2003
• Status: Active Grant

• Current Assignee: Healgen Scientific, LLC (Zhejiang Orient Gene Biotech Co., Ltd.)
• Original Assignee: American Bio Medica Corporation
• Inventors: Gould, Martin, Vallejo, Yli Remo, Bernstine, Robert
• Primary Examiner(s): Le, Long V.
• Assistant Examiner(s): YU, MELANIE J
• Application Number:
  US10/695,145
• Time in Patent Office: 1,022 Days
• Field of Search: 422/50, 422/56, 422/55, 422/61, 422/68.1, 422/69, 422/70, 435/4, 435/7.1, 435/7.94, 435/174, 435/283.1, 435/287.1, 435/287.2, 435/287.7, 435/288.2, 435/288.7, 436/161, 436/162, 436/518, 436/501, 436/529, 436/528
• US Class Current: 422/413
• 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 33/558 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 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. The pre-treatment reagent is contained within a rupturable enclosure. A piercing member is located within the housing that is used to rupture the enclosure in order to release the pre-treatment reagent so that the sample and pre-treatment reagent form a mixture. The second reagent may then be introduced to the mixture which is allowed to react with the second reagent for a period of time. The mixture and second reagent combination is then contacted with the immunoassay test strip.

Claims

1. A lateral flow immunoassay device comprising:

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;

a second chamber containing a second reagent;

means for 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;

means for 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;

means for holding said elongated holder member at a position spaced from the second chamber until said elongated holder member is activated; and

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

2. The lateral flow immunoassay device of claim 1 wherein said pre-treatment reagent includes a buffer solution.

3. The lateral flow immunoassay device of claim 1 wherein said second reagent is a binder.

4. The lateral flow immunoassay device of claim 3 wherein said binder is a colloid gold-antibody complex.

5. The lateral flow immunoassay device of claim 1 wherein said second reagent is an antigen.

6. The lateral flow immunoassay device of claim 1 wherein said pre-treatment reagent is contained within a rupturable enclosure.

7. The lateral flow immunoassay device of claim 6 wherein said contacting means includes 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.

8. The lateral flow immunoassay device of claim 1 wherein said introducing means includes apertures in communication with said second chamber through which said mixture flows and contacts said second reagent.

9. The lateral flow immunoassay device of claim 1 wherein said means for holding said elongated holder member prevents the test strip from contacting the mixture and second reagent combination until activated.

10. The lateral flow immunoassay device of claim 1 wherein said means for holding the test sample collector includes an elongated slot.

11. The lateral flow immunoassay device of claim 6 wherein said contacting means includes 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.

12. The lateral flow immunoassay device 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.

13. The lateral flow immunoassay device of claim 12 wherein said test strip is located within said vertical leg.

26. The lateral flow immunoassay device of claim 1 wherein the pre-treatment reagent dilutes or denatures interferants in the test sample.

14. A lateral flow immunoassay device comprising:

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;

a second chamber containing a second reagent;

means for permitting the test sample, the first reagent and the second reagent to mix in the second chamber prior to contacting the mixture of the first reagent, second reagent and test sample with a test strip;

means for holding said elongated holder member at a position spaced from the second chamber until said elongated holder member is activated; and

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

15. The lateral flow immunoassay device of claim 14 wherein said first reagent is contained in a rupturable enclosure.

16. The lateral flow immunoassay device of claim 14 wherein said first reagent includes a buffer solution.

17. The lateral flow immunoassay device of claim 14 wherein said second reagent is a binder.

18. The lateral flow immunoassay device of claim 17 wherein said binder is a colloidal gold-antibody complex.

19. The lateral flow immunoassay device of claim 14 wherein said second reagent is an antigen.

20. The lateral flow immunoassay device of claim 15 further including 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.

21. The lateral flow immunoassay device of claim 14 further including apertures in communication with said second chamber through which said first reagent flows and contacts said second reagent.

22. The lateral flow immunoassay device of claim 14 wherein said means for holding the test sample collector includes an elongated slot.

23. The lateral flow immunoassay device of claim 15 further including 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.

24. The lateral flow immunoassay device of claim 14 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.

25. The lateral flow immunoassay device of claim 24 wherein said test strip is located within said vertical leg.

27. The lateral flow immunoassay device of claim 14 wherein the first reagent dilutes or denatures interferants in the test sample.