Development and Commercialization of Analyte Specific Reagents (ASRs) for the Diagnosis of Rickettsial Diseases on FDA-cleared Real-time PCR Platforms

During Phase I, probes and primers were designed for six Rickettsial diseases: Rickettsia typhi (murine typhus); Spotted Fever Group (SFG); Orientia tsutsugamushi (scrub typhus); Coxiella burnetii (Q fever); Anaplasma phagocytophilum; and Ehrlichiae. Signature sets (probes and primers) for four of the pathogens were synthesized and tested, as were positive and negative controls. Phase II will extend the work, establishing limits of detection, linearity, sensitivity, and specificity for the assays. In collaboration with the Army, further testing will include clinical samples from infected personnel and comparison to "gold standards". At least three lots of the successful assays will be manufactured under cGMP guidelines according to the FDA, and provided to the military for testing as Analyte Specific Reagents (ASRs). Feedback from military medical personnel will be used to format assays which can be used in existing JBAIDS qPCR instruments.