IP Library Granted Patent US 7,192,721
Granted Patent B1
US 7,192,721 · App. 11/222,449 · Granted Mar 20, 2007

Universal rapid test and method for detection of tuberculosis in multiple host species

Assignee: Chembio Diagnostic Systems, Inc.
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Quick Facts
Patent No.
US 7,192,721
App. No.
11/222,449
Granted
Mar 20, 2007
Kind
B1
Abstract

A universal test apparatus for detecting tuberculosis (TB) in any of many different species of non-primate mammals is provided. The universal test apparatus includes a test site having a mycobacterial antigen cocktail comprising ESAT-6/CFP10 and 16 kDa/MPB83 polyfusion antigens, and a tracer having the ESAT-6/CFP10 polyfusion antigen and MPB83 antigen conjugated to latex or colloidal gold. The universal test apparatus is effective across genuses, families and orders of non-primate mammals.

Claims (47)

1. A test apparatus for detecting antibodies to a mycobacterial antigen in non-primate mammals, comprising of a test strip having thereon a mycobacterial antigen cocktail consisting essentially of either (i) ESAT-6, CFP10, and MPB83 antigens or amino acid sequence fragments thereof exhibiting antigenic activity, or (ii) ESAT-6, CFP10, MPB83, and M. tuberculosis 16 kDa antigens or amino acid sequence fragments thereof exhibiting antigenic activity.

2. A test apparatus according to claim 1 , wherein:

said ESAT-6 and CFP10 are included as a polyfusion protein ESAT-6/CFP10.

3. A test apparatus according to claim 2 , wherein:

said MPB83, and M. tuberculosis 16 kDa are included as a polyfusion protein 16 kDa/MPB83.

4. A test apparatus according to claim 3 , wherein:

said ESAT-6/CFP10 and said 16 kDa/MPB83 are included in approximately equal amounts.

5. A test apparatus according to claim 1 , further comprising:

a tracer including ESAT-6, CFP10, and MPB83 antigens or amino acid sequence fragments thereof exhibiting antigenic activity.

6. A test apparatus according to claim 5 , wherein:

said ESAT-6 and said CFP10 of said tracer are included as a polyfusion protein ESAT-6/CFP10.

7. A test apparatus according to claim 6 , wherein:

said polyfusion protein ESAT-6/CFP10 and said antigen MPB83 are included in approximately equal amounts in said tracer.

8. A test apparatus according to claim 5 , wherein:

said tracer includes colloidal gold or colored latex.

9. A test apparatus according to claim 8 , wherein:

said tracer includes rabbit IgG.

10. A method of testing multiple non-primate mammals for mycobacterial antibodies, comprising:

a) obtaining a corresponding multiple of test devices, each test device comprising a test strip having thereon a mycobacterial antigen cocktail comprising ESAT-6, CFP10, MPB83 antigens or amino acid sequence fragments thereof exhibiting antigenic activity;

b) obtaining bodily fluid from each of said multiple non-primate mammals;

c) applying said bodily fluid of each of said multiple non-primate mammals to a respective corresponding test device; and

d) inspecting said test devices to determine the presence or lack thereof of said mycobacterial antibodies, wherein

said multiple non-primate mammals include non-primate mammals of at least two different genuses.

11. A method according to claim 10 , wherein:

said multiple non-primate mammals include non-primate mammals of at least two different families.

12. A method according to claim 11 , wherein:

said multiple non-primate mammals include mammals of at least two different orders.

13. A method according to claim 10 , wherein:

said multiple non-primate mammals include at least two of cattle, buffalo, white-tailed deer, reindeer, Brockett deer, elk, badger, possum, lion, lynx, wild boar, elephant, gazelle, rhino, giraffe, tapir, llama, alpaca, jaguar, bongo, and kudu.

14. A method according to claim 10 , wherein:

said mycobacterial antigen cocktail further comprises M. tuberculosis 16 kDa.

15. A method according to claim 14 , wherein:

said mycobacterial antigen cocktail consists essentially of ESAT-6, CFP10, MPB83 and M. tuberculosis 16 kDa antigens or amino acid sequence fragments thereof exhibiting antigenic activity.

16. A method according to claim 14 , wherein:

said ESAT-6 and CFP10 are included as a polyfusion protein ESAT-6/CFP10.

17. A method according to claim 16 , wherein:

said MPB83 and M. tuberculosis 16 kDa are included as a polyfusion protein 16 kDa/MPB83.

18. a method according to claim 10 , wherein:

said plurality of test devices further include a tracer including ESAT-6, CFP10, MPB83 antigens or amino acid sequence fragments thereof exhibiting antigenic activity.

19. A method according to claim 18 , wherein:

said ESAT-6 and said CFP10 of said tracer are included as a polyfusion protein ESAT-6/CFP10.

20. A method according to claim 19 , wherein:

said polyfusion protein ESAT-6/CFP10 and said MPB83 are included in approximately equal amounts in said tracer.

21. A method according to claim 18 , wherein:

said tracer includes colloidal gold or colored latex.

22. A method according to claim 21 , wherein:

said tracer includes rabbit IgG.

Assignments (2)
SECURITY INTEREST Recorded Sep 6, 2019
From: CHEMBIO DIAGNOSTICS, INC.; CHEMBIO DIAGNOSTIC SYSTEMS INC.
To: PERCEPTIVE CREDIT HOLDINGS II, LP, AS ADMINISTRATIVE AGENT
Reel/Frame 050296/0001 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 15, 2005
From: ESFANDIARI, JAVANBAKHSH; LYASHCHENKO, KONSTANTIN
To: CHEMBIO DIAGNOSTIC SYSTEMS, INC.
Reel/Frame 017019/0367 →
Continuity (2)
Continuation In Part 1121292200 · Aug 26, 2005
Provisional Application 6060530400 · Aug 26, 2004