FDA : Laboratory Flexible Funding Model (MICROBIOLOGY)

项目摘要/摘要 密歇根州卫生与公众服务部，实验室局(MDHHS-BOL)传染病 微生物科疾病科与美国农业部蕨类植物建立了牢固的工作关系 15年。MDHHS微生物学部分是CDC PulseNet计划的中西部区域实验室 具有增强的能力和全基因组测序(WGS)能力。BOL已通过国际标准化组织17025认证 美国工业卫生协会实验室认可计划(AIHA-LAP，LLC)标准 在食品实验室认可计划(Food LAP)中；拥有美国疾病控制与预防中心的注册证书 联邦选择代理计划(FSAP)和美国农业部APHIS许可；已被指定为一级生物 实验室反应网络(LRN)内的实验室执行与食源性疫情有关的检测 调查；并拥有生物恐怖主义代理人的经验和设施。在此提出的目标 旨在提高检测食品中细菌病原体的能力和能力， 因此，支持和提高实验室的粮食防御任务和疫情应对能力 在密歇根州。 目标1：主要目标是为BSL3的食品分析提供浪涌能力测试 挑选药剂并参与FDA的监测和特殊活动。 目的：研究与食源性疾病相关的肠道病原菌的基因组多样性。 由WGS作为GenomeTrakr网络的成员从人类食物中分离出来。这一增强的能力将允许 MDHHS获得改进的测序比较和分析，这反过来将改善疫情 调查和食品安全。 目的：发展检测人类食品中环孢子菌的能力和能力。跟随 培训和能力这将提高实验室在爆发时检测环孢子菌的能力。 MDHHS还将能够在特殊活动中协助FDA进行环孢子菌检测。

Project summary/Abstract The Michigan Department of Health and Human Services, Bureau of Laboratories (MDHHS-BOL) Infectious Disease Division, Microbiology Section has built a strong working relationship with USDA FERN for more than 15 years. The MDHHS Microbiology section is the Midwest regional laboratory for the CDC PulseNet program with enhanced capacity and capabilities for Whole Genome sequencing (WGS). BOL is accredited to ISO 17025 standard by the American Industrial Hygiene Association Laboratory Accreditation Program (AIHA-LAP, LLC) in their Food Laboratory Accreditation Program (Food LAP); has a Certificate of Registration with the CDC Federal Select Agent Program (FSAP) and a USDA APHIS permit; has been designated as an Tier-1 Biological lab within the Laboratory Response Network (LRN) performing testing associated with foodborne outbreak investigations; and has experience with and facilities for the agents of bioterrorism. The objectives proposed here are intended to enhance the capacity and capabilities in the detection of bacterial pathogens in food products, thereby, supporting and improving the laboratory capacities for food defense assignments and outbreak response in State of Michigan. Objective 1: The primary goal is to provide surge capacity testing for the analysis of food products for BSL3 bacterial select agents and participate in FDA surveillance and special event activities. Objective 2: To study the genomic diversity of enteric pathogens associated with food borne illness collected from human food by WGS as a member of the GenomeTrakr network. This increased capability will allow MDHHS access to improved comparison and analysis of sequencing, which in turn, will improve outbreak investigations and food safety. Objective 3: To develop the capacity and capability for detecting Cyclospora in human food products. Following training and competency this would increase the lab’s ability to detect Cyclospora in the event of an outbreak. MDHHS would also be able to assist FDA in special events in testing for Cyclospora.