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Development of an Alternative Screening Method for Detecting Evidence of Mycobacterium Tuberculosis Infections

Award Information
Agency: Department of Defense
Branch: Defense Health Agency
Contract: FA8650-13-C-6393
Agency Tracking Number: O2-1350
Amount: $750,000.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: OSD11-H05
Solicitation Number: 2011.2
Solicitation Year: 2011
Award Year: 2013
Award Start Date (Proposal Award Date): 2013-04-25
Award End Date (Contract End Date): 2015-07-31
Small Business Information
2585 Nina Street
Pasadena, CA -
United States
DUNS: 011114167
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 Hiep-Hoa Nguyen
 (714) 791-1774
Business Contact
 Hiep-Hoa Nguyen
Title: President
Phone: (714) 791-1774
Research Institution

The objective of this proposal is to develop an alternative to the tuberculin test and interferon- & #61543; & #61472;release assays for the diagnosis of active and latent tuberculosis. Toward this end, a rapid lateral flow test based on the detection of blood antibodies specific to Mycobacteria tuberculosis antigens will be devised for the serodiagnosis of active and latent TB. Selected and highly immunogenic antigen panel from regions of difference in the genome of M. tuberculosis will be attempted. An extensive TB serum collection that will also contain a sufficient number of co-infected HIV and TB samples and multidrug resistant TB samples will be assembled to ensure statistically significant analysis. A number of novel approaches to enhance the overall sensitivity of the lateral flow immunochromatographic devices will be investigated. The recombinant antigens will be screened by ELISAs and lateral flow immunochromatographic assays using our TB and control serum collections. It is expected that an optimal combination of antigens will be formulated to achieve highest possible response rate for TB detection with the lateral flow format. Site(s) for clinical evaluation of the best performing lateral flow devices will be selected such that clinical data needed for a 510K FDA application can be collected.

* Information listed above is at the time of submission. *

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