口罩中金黄色葡萄球菌检测能力验证样品的研制及应用

Development and application of proficiency verification for the detection of Staphylococcus aureus in masks

目的研制一种含菌口罩样品,应用于一次性使用卫生用品致病菌检测的能力验证项目。方法通过人工污染及冷冻干燥的方法制备含菌口罩样品,阳性样品中含有目标菌金黄色葡萄球菌、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、阳性样品各10瓶,进行均匀性检测;将样品分别置于-20℃、4℃贮藏120 d,在25℃、36℃和42℃贮藏20~60 d,监测其稳定性,依据GB 15979-2002检测金黄色葡萄球菌,检测结果应与指定值一致。每家参加验证的实验室发放2份样品,其中至少1份阳性样品,其余随机发放。结果样品的均匀性满足要求,贮存稳定性可达120 d,运输稳定性中42℃下可达15 d,以上结果均满足能力验证实施条件。本次能力验证共有299家实验室参试,其中280家评价满意,占93.6%;19家实验室评价不满意,占6.4%。结论口罩中金黄色葡萄球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映参试单位的检测环境及检测能力。

Objective To develop a kind of bacteria-containing mask sample,which can be used in the national proficiency testing project for the detection of pathogenic bacteria in the single-use hygiene products.Methods The bacteria-containing mask samples were prepared by artificial contamination and freeze drying.The positive sample contained target bacteria Staphylococcus aureus,interference bacteria and background bacteria,while the negative samples contained only interference bacteria and background bacteria.Twenty negative and ten positive samples were randomly selected for uniformity testing.The samples were stored at-20℃and 4℃for 120 days,and stored at 25℃,36℃and 42℃for 20-60 days to monitor their stability.Staphylococcus aureus was detected according to GB15979-2002,and the detection results should be consistent with the specified value.Each participating laboratory distributed 2 samples,with at least 1 positive sample and the rest randomly distributed.Results The uniformity of the samples met the requirements,the storage stability reached 120 days,and the transport stability reached 15 days at 42℃.All the above results met the implementation conditions of capability verification.A total of 299 laboratories participated in this capacity verification project,among which 280 were satisfied with the evaluation,accounted for 93.6%,19 laboratories(6.4%)failed to satisfied with the evaluation.Conclusion The proficiency testing samples for the detection of Staphylococcus aureus in masks can meet the requirements of proficiency verification,and this ability verification can truly reflect the detection environment and capacity of the participate agents.