This SBIR project is a collaborative effort between AC Diagnostics, Inc. and the University of Pennsylvania to develop and demonstrate a novel diagnostic system for automated on-site detection of viral pathogens in biomedical laboratory animals. Microbial infections and outbreaks threaten the survival or utility of biomedical animal models used in current and future research. It is therefore crucial to accurately and timely identify current and emerging pathogens in lab animal populations and facilities to assure pathogen-free biological resources.<P> Current diagnostic methods for the animal pathogens are time-consuming and expensive, and are therefore mainly limited to large research or diagnostic laboratories. There is no commercial product available for routine applications. Consequently, automated, simple-to- operate technologies as standardized or user configurable commercial products are urgently needed for rapid, reliable and cost-effective detection and identification ofthe pathogenic microbes in laboratory animal populations and settings. <P>The technology proposed in this project integrates automated viral RNA isolation from raw samples and real-time nucleic acid sequence-based amplification (NASBA) detection into a sensitive, reliable and low-cost (< $10) diagnostic system. We anticipate a limit of detection of less than 10 viruses, and test times within 60 minutes. <P>The primary specific aims of Phase I are to develop a prototype assay system and demonstrate its feasibility for detecting animal viruses in blood. The ultimate goal of this project is to develop an on-site assay device which is consisted of single-use (disposable) self-contained credit-card sized assay cassette and a fully- automated portable detector for completely automated detection of laboratory animal viruses. The final product will be fully developed and validated in the Phase II of this project. <P>The successful completion of thisproject will significantly advance animal virus detection, and provide a simple on-site assay device with minimum operator attention or skill requirement. The same technology can also be used as a platform for other pathogens such as viruses in nonhuman primates and bacterial pathogens, and as a part of standardized operation procedures in daily laboratory animal care.
Public Health Relevance: <br/> The successful completion of this project will significantly advance the technique of virus detection, and provide a general platform for the detection of other animal pathogens such as viruses in nonhuman primates and bacterial pathogens. This novel device will have widespread applicability as a standardized and streamlined commercial product and procedure for rapid, reliable and cost-effective detection and identification of the microbes in laboratory animal cares. Therefore it will meet the requirements for establishing pathogen-free biological resources for current and future biomedical research needs.