范一灵, 李芳, 杨燕, 秦峰, 刘浩, 杨美成. 含药品基质的金黄色葡萄球菌能力验证样品的制备与评估[J]. 上海预防医学, 2022, 34(3): 279-282. DOI: 10.19428/j.cnki.sjpm.2022.21238
引用本文: 范一灵, 李芳, 杨燕, 秦峰, 刘浩, 杨美成. 含药品基质的金黄色葡萄球菌能力验证样品的制备与评估[J]. 上海预防医学, 2022, 34(3): 279-282. DOI: 10.19428/j.cnki.sjpm.2022.21238
FAN Yiling, LI Fang, YANG Yan, QIN Feng, LIU Hao, YANG Meicheng. Sample preparation and analysis of proficiency test containing Staphylococcus aureus with drug matrix[J]. Shanghai Journal of Preventive Medicine, 2022, 34(3): 279-282. DOI: 10.19428/j.cnki.sjpm.2022.21238
Citation: FAN Yiling, LI Fang, YANG Yan, QIN Feng, LIU Hao, YANG Meicheng. Sample preparation and analysis of proficiency test containing Staphylococcus aureus with drug matrix[J]. Shanghai Journal of Preventive Medicine, 2022, 34(3): 279-282. DOI: 10.19428/j.cnki.sjpm.2022.21238

含药品基质的金黄色葡萄球菌能力验证样品的制备与评估

Sample preparation and analysis of proficiency test containing Staphylococcus aureus with drug matrix

  • 摘要:
    目的 制备含有药品基质的金黄色葡萄球菌能力验证样品,开展药品微生物能力验证计划,了解我国药品微生物检验行业的技术水平。
    方法 制备2种含活菌的药品微生物能力验证样品,并开展均匀性和稳定性评估,对63家参与能力验证计划的实验室提交的检测结果和调查问卷进行统计与分析。
    结果 制备的能力验证样品的均匀性和稳定性均符合CNAS⁃CL03《能力验证提供者认可准则(2010版)》的要求。样品可在-20 ℃稳定储存至少6个月。在63家参与能力验证的实验室中,有53家的检测结果被评定为“满意”,占84.1%(53/63)。其中隶属于政府的药品检测机构17家,占27.0%(17/63),满意率为94.1%(16/17);药品生产企业质控实验室43家,占68.3%(43/63),满意率为81.4%(35/43);非政府检测机构3家,占4.8%(3/63),满意率为66.7%(2/3)。
    结论 政府检测机构在微生物检测能力上整体良好,部分企业实验室的微生物检测能力有待提高。药品微生物能力验证样品的研制可为评价药品微生物检测实验室提供质量控制工具。

     

    Abstract:
    Objective To prepare samples of proficiency testing (PT) containing live Staphylococcus aureus with drug matrix in microbial PT program of drug testing, and to evaluate the laboratory capability of microbiology tests in China.
    Methods Two kinds of PT samples containing living bacteria with drug matrix were prepared and evaluated. The results of laboratories participated in PT program and their response to the survey questionnaire were collected and analyzed.
    Results The homogeneity and stability of the PT samples complied with the requirements of CNAS-CL03: 2010. Samples could be stored stably for at least 6 months at -20 ℃. Among 63 laboratories participating in PT program, 53 laboratories (84.1%) achieved satisfactory results. The satisfaction rate was 94.1% (16/17) in 17 government laboratories (27.0% of total 63 laboratories), 81.4% (35/43) in 43 pharmaceutical quality control laboratories (68.3% of total 63 laboratories), and 66.7% (2/3) in 3 non-government laboratories (4.8% of total 63 laboratories), respectively.
    Conclusion The government laboratories performed better than pharmaceutical quality control laboratories in microbiology tests of drug, and the testing abilities of some pharmaceutical laboratories needs to be improved. The preparation and application of microbial samples in drug matrix could provide evaluation tools for drug testing laboratories in microbiology.

     

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