Software Technology for QFT-GIT ELISA Reader

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.