TIGER Biosensor for Broad Viral Detection and Genetically Engineered Microbes

The ability to detect all viruses that cause disease in humans in a single test would be a historical advance in healthcare for civilians and military personnel. Proof-of-principle for such a test was demonstrated during the Phase I program: We analyzed a blinded panel of 50 samples comprised of 15 viral species from seven viral families using a single test with 100% accuracy. The virus detection assay is performed on the Ibis T5000, a fully automated, high-throughput biosensor platform developed under DARPA-sponsorship, that combines PCR with electrospray ionization mass spectrometry (ESI-MS). We propose to develop and validate a single, expanded assay that will detect and identify multiple members of over 20 virus families, covering thousands of viruses, including essentially all viruses known to cause disease in humans. The assay will be validated and tested on blinded human serum samples and compared with gold standard methods. In addition to the diagnosis of infectious disease in humans, the assay will also be useful for screening of donated blood.