口罩中绿脓杆菌检测能力验证样品的研制及应用

Development and Application of Samples for Proficiency Testing of Pseudomonas aeruginosa in Masks

本研究研制了一种含菌口罩样品,并将其应用于一次性使用卫生用品致病菌检测的国家级能力验证项目。利用人工污染及冷冻干燥技术制备了含菌口罩样品。阳性样品中含有目标菌、干扰菌及背景菌,阴性样品仅含有干扰菌及背景菌。随机抽取阴性样品20瓶、阳性样品10瓶,进行均匀性检测;将样品分别置于-20℃、4℃下贮藏120 d,在25℃、36℃和42℃下贮藏20~60 d并监测其稳定性,依据GB 15979-2002附录B5对绿脓杆菌检测方法进行检验,检测结果应与指定值一致。发放2份样品,实验室最少收到1份阳性样品,其余随机发放。为防止数据串通,将样本随机编号并缩短结果上报时间。检测结果显示,样品的均匀性、贮存稳定性和运输稳定性均能满足能力验证要求。经过考核,290家实验室评价满意,占98.3%;5家实验室评价不满意,占1.7%。这些结果表明口罩中绿脓杆菌检测能力验证样品可以满足能力验证要求,本次能力验证可真实反应参试单位的检测环境和设施条件及检测水平,并提升一次性使用防疫物资的产品质量安全。

To develop a bacteria-containing mask sample for the national proficiency testing project for the detection of pathogenic bacteria in the field of disposable sanitary products, the bacteria-containing mask samples were prepared by artificial contamination and freeze-drying. Positive samples contain target bacteria, interfering bacteria and background bacteria, while negative samples only contain interfering bacteria and background bacteria. Randomly select 20 bottles of negative samples and 10 bottles of positive samples for homogeneity testing;store the samples at-20℃ and 4℃ for 120 days, and store them at 25℃,36℃ and 42℃ for 20-60 days to monitor their stability. According to GB 15979-2002 Appendix B5 Pseudomonas aeruginosa detection method, the test results should be consistent with the assigned value. Two samples will be distributed, and the laboratory will receive at least 1 positive sample, and the rest will be distributed randomly. In order to prevent data collusion, the samples were randomly numbered and the result reporting time was shortened. Results showed that the samples could meet the requirements of proficiency testing in terms of homogeneity, storage stability and transportation stability. The results of 290 laboratories that passed the assessment were satisfactory, accounting for 98.3%;the results of 5 laboratories were dissatisfactory, accounting for 1.7%. The proficiency testing samples for the detection of Pseudomonas aeruginosa in masks can meet the requirements of proficiency testing.This proficiency testing can truly reflect the testing environment and testing level of the participating organizations, and improve the product quality and safety of disposable anti-epidemic materials.