SBIR-STTR Award

We propose to adapt the TIGER universal biosensor to identify viruses present in blood samples. The advantages of the TIGER biosensor include: (1) rapid analysis of a sample; (2) a high, continuous throughput rate; (3) ability to identify and phylogenetically classify a heretofore unknown virus; (4) the power to strain-type a virus when strain specific sequence data are available for the species, and (5) ability to simultaneously identify the presence of multiple viral agents in a sample and report the quantity of each. Further, a modified TIGER protocol can also be used to detect presence of genetically modified viruses. These features make TIGER the ideal universal virus identification system for blood supply monitoring for the army. While expanding the scope of organisms routinely screened in donated blood has great value in its own right, the crucial benefit from this proposal will be to provide the army with the ability to assure the safety and security of the blood supply during rapidly developing crisis situations due to a newly emerging infectious disease or a bioterrorist attack

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.

Keywords:
Universal Virus Detection, Viruses, Diagnostic, Pcr/Esi-Ms, Infectious Disease, Blood Screening, Serum Screening