This consensus document presents the suggested guidelines developed by the Laboratory Technology Committee (LTC) of the American Association of Veterinary Laboratory Diagnosticians (AAVLD) for development, validation, and modification (methods comparability) of real-time PCR (rtPCR) assays. These suggested guidelines are presented with reference to the World Organisation for Animal Health (OIE) guidelines for validation of nucleic acid detection assays used in veterinary diagnostic laboratories. Additionally, our proposed practices are compared to the guidelines from the Foods Program Regulatory Subdivision of the U.S. Food and Drug Administration (FDA) and from the American Society for Veterinary Clinical Pathology (ASVCP). The LTC suggestions are closely aligned with those from the OIE and comply with version 2021-01 of the AAVLD Requirements for an Accredited Veterinary Medical Diagnostic Laboratory, although some LTC recommendations are more stringent and extend beyond the AAVLD requirements. LTC suggested guidelines are substantially different than the guidelines recently published by the U.S. FDA for validation and modification of regulated tests used for detection of pathogens in pet food and animal-derived products, such as dairy. Veterinary diagnostic laboratories that perform assays from the FDA Bacteriological Analytical Method (BAM) manual must be aware of the different standard.

本共识文件介绍了美国兽医实验室诊断协会 (AAVLD) 实验室技术委员会 (LTC) 为实时 PCR (rtPCR) 检测的开发、验证和修改（方法可比性）制定的建议指南。这些建议的指南是参考世界动物卫生组织 (OIE) 兽医诊断实验室中使用的核酸检测分析验证指南提出的。此外，我们提出的做法与美国食品和药物管理局 (FDA) 食品计划监管部门和美国兽医临床病理学会 (ASVCP) 的指南进行了比较。LTC 的建议与 OIE 的建议密切一致，并符合 AAVLD 对认可兽医医学诊断实验室的要求 2021-01 版，尽管有些 LTC 建议更为严格并超出了 AAVLD 的要求。LTC 建议的指南与美国 FDA 最近发布的用于验证和修改用于检测宠物食品和动物源产品（例如乳制品）中病原体的监管测试的指南有很大不同。根据 FDA 细菌学分析方法 (BAM) 手册进行检测的兽医诊断实验室必须了解不同的标准。