Software Technology for QFT-GIT ELISA Reader

Award Information
Agency:
Department of Defense
Branch:
Air Force
Amount:
$749,971.00
Award Year:
2008
Program:
SBIR
Phase:
Phase II
Contract:
FA8650-08-C-6871
Agency Tracking Number:
O063-H06-3142
Solicitation Year:
2006
Solicitation Topic Code:
OSD06-H06
Solicitation Number:
2006.3
Small Business Information
CELADON LABORATORIES, INC.
6525 Belcrest RD, Hyattsville, MD, 20782
Hubzone Owned:
N
Socially and Economically Disadvantaged:
N
Woman Owned:
N
Duns:
788153166
Principal Investigator
 Raymond Peterson
 Chief Scientific Officer
 (301) 683-2118
 peterson@celadonlabs.com
Business Contact
 Lawrence Kessner
Title: CEO
Phone: (301) 683-2117
Email: lkessner@celadonlabs.com
Research Institution
N/A
Abstract
Tuberculosis is an ongoing threat to military personnel, and to public health generally. Screening for latent infection continues to be done by the tuberculin skin test; however, to overcome high false-positive and false-negative rates produced by the test,the Air Force is conducting a clinical trial of the QFT-GIT test kit. The clinical trial provides an opportunity for development of a software platform that manages and interprets test data. In Phase I, Celadon successfully delivered software that transforms optical density readings from the Triturus ELISA reader into QFT-GIT clinical results. The delivered software performs the following functions: Accepts the Triturus file as input; Applies and evaluates QFT-GIT calibrator quality control rules; calculates log-linear calibration curve; plots calibration curve and calibrators, and applies quality control rules to the curve; applies curve to back-fit calibrators; applies curve to inverse predict the IF-y concentration of samples for 3 tests; applies QFT-GIT rules to 3 test results to produce clinical result of positive, negative, and indeterminite. In Phase II we will continue to develop the system so that critical features will be configurable by system administrator with no coding. Upon completion of Phase II, the system will have these features: No. of calibration levels and replicates; calibration quality control rules of same format as QFT-GIT test; calibration curves with option to specify many common models; clinical interpretation rules with same format as QFT-GIT test.

* information listed above is at the time of submission.

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