An automated on-site detection system for viral pathogens of biomedical laborator

描述（由申请人提供）：这个SBIR项目是AC诊断公司和宾夕法尼亚大学之间的合作成果，旨在开发和演示一种用于生物医学实验动物病毒病原体自动现场检测的新型诊断系统。微生物感染和爆发威胁到当前和未来研究中使用的生物医学动物模型的生存或效用。因此，准确和及时地识别实验动物种群和设施中现有和新出现的病原体，以确保无病原体的生物资源至关重要。目前对动物病原体的诊断方法既耗时又昂贵，因此主要局限于大型研究或诊断实验室。没有商业产品可用于日常应用。因此，迫切需要自动化、易于操作的标准化技术或用户可配置的商业产品来快速、可靠和经济地检测和识别

DESCRIPTION (provided by applicant): 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. 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 of the pathogenic microbes in laboratory animal populations and settings. 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. 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. The successful completion of this project 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. 1 PUBLIC HEALTH RELEVANCE: 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.