Software Technology for QFT-GIT ELISA Reader

Tuberculosis is a growing threat to military personnel. The accepted method of preventing tuberculosis disease in military personnel is to screen for latent infection using the tuberculin skin test. In order to overcome the high false-positive and false-negative rates of the skin test, the Air Force is conducting a clinical trial of the Cellestis QFT-GIT test kit. The clinical trial presents the opportunity for a software system that manages and interprets QFT-GIT test data. The deliverable of this Phase 1 SBIR proposal is software that transforms optical density readings from the Triturus ELISA reader into QFT-GIT clinical results. It will communicate electronically with the Triturus using the ASTM standard and it will communicate electronically with CHCS using the HL7 standard. Delivery of this system will establish feasibility of the entire project. Additionally during Phase 1 the proposer will perform a comprehensive requirements analysis for Phase 2. Phase 2 deliverables will include DITSCAP accreditation and software validation as well all other deliverables identified in the requirements analysis proposed for Phase 1. Phase 2 deliverables may include a data management system, software for manual editing of instrument sample layout, configuration of the Triturus software, and analysis of the clinical trial data.