Abstract: Objective　Analyze the monitoring results of microbiological and genetic quality of commonly used laboratory animals in Beijing from 2020 to 2022, so as to provide quality references for laboratory animal production units, users and testing institutions. Methods　In accordance with current valid national standards of the People’s Republic of China and local standards of Beijing Municipality, random inspections of laboratory animals in Beijing were conducted by the Beijing Office for Laboratory Animal Administration (Beijing Office for Human Genetic Resources Administration), with quality inspection reports issued based on the test results. According to the monitoring data, quality analyses were conducted on different grades of mice, rats, guinea pigs, hamsters, rabbits, dogs, monkeys, minipigs and laboratory fish in Beijing from 2020 to 2022. Results　During three years, a total of 3 723 batches of animals from 185 institutions were randomly inspected. The number of non-conforming batches in microbial detection was 26, 20 and 19 respectively. The main cause of non-conformity was positive pathogenic microorganisms (19 batches). All immunological indicators were qualified, and no genetic variation was found.Conclusion　From 2020 to 2022, the genetic quality of laboratory animals in Beijing was fully qualified, and the number of microbiologically non conforming batches decreased year by year, indicating a steady improvement in overall quality. The quality supervision of laboratory animals acts as a supervisory and regulatory measure, providing scientific guidance for practitioners to control and improve the quality of laboratory animals. Normalized quality sampling and supervision are of great significance in ensuring the scientificity and reliability of life science research, biomedical research and development, and other related work.

Key words:  laboratory animals, Beijing area, quality inspection, microorganisms, genetics, sampling inspection

摘要： 目的　分析2020年至2022年北京地区常用实验动物微生物和遗传质量监测结果,为实验动物生产单位、使 用单位和检测单位提供质量参考。方法　按照现行有效中华人民共和国国家标准和北京市地方标准,由北京市实 验动物管理办公室(北京市人类遗传资源管理办公室)抽检北京地区实验动物,根据检测结果出具检测质量报告。 根据检测结果,对2020年至2022年不同等级小鼠、大鼠、豚鼠、地鼠、兔、犬、猴、小型猪、实验鱼进行质量结果分析。 结果　3年间累计抽检185家单位3 723批次动物,微生物检测不合格的动物批次分别为26批、20批和19批,不 合格主要因素为病原微生物阳性19批,免疫情况均合格,未发现遗传变异。结论　北京市2020年至2022年实验 动物遗传质量全合格,微生物不合格批次逐年下降,整体质量稳定向好。实验动物质量监管对实验动物质量是一 种监督规范措施,对实验动物相关从业者掌控并提升实验动物质量起到科学指导作用。常态化的质量抽检监管对 保障生命科学研究、生物医药研发等相关工作的科学性与可靠性具有重要意义。

关键词: 实验动物, 北京地区, 质量检测, 微生物, 遗传, 抽检分析