噬菌体ΦX174标准物质定值方法研究
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摘要
采用国际标准ISO 16604中噬菌体ΦX174的双层琼脂计数方法作为噬菌体ΦX174标准物质定值方法,针对该方法进行了方法验证和协同实验验证以及不确定度分析。结果显示,该方法重复性和复现性均较好,室内重复性相对标准偏差为10. 18%,室间相对标准偏差为14. 58%。经统计分析,双层琼脂计数法相对扩展不确定度为12. 44%,适用于噬菌体ΦX174标准物质的定值,对于人员防护装备防护性能评价具有重要意义。
The double-layer agar counting method of phage ΦX174 in international standard( ISO 16604) was adopted as the calibration method of phage ΦX174 standard substance,and the method was validated by the method and verified by synergistic experiment and the uncertainty analysis. The results showed that the repeatability and reproducibility of the method were good,the relative standard deviation of indoor repeatability was 10. 18%,and the relative standard deviation was 14. 58%. According to the statistical analysis,the relative expansion uncertainty of the double agar counting method was 12. 44%,which was suitable for the determination of the standard substance of phage ΦX174,which was very important for the evaluation of protective performance of personnel protective equipment.
The double-layer agar counting method of phage ΦX174 in international standard( ISO 16604) was adopted as the calibration method of phage ΦX174 standard substance,and the method was validated by the method and verified by synergistic experiment and the uncertainty analysis. The results showed that the repeatability and reproducibility of the method were good,the relative standard deviation of indoor repeatability was 10. 18%,and the relative standard deviation was 14. 58%. According to the statistical analysis,the relative expansion uncertainty of the double agar counting method was 12. 44%,which was suitable for the determination of the standard substance of phage ΦX174,which was very important for the evaluation of protective performance of personnel protective equipment.
引文
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[2]卫生部卫生法制与监督司.消毒技术规范[S].北京:中华人民共和国卫生部,2002.
[3]祁国明.病原微生物实验室生物安全[M].北京:人民卫生出版社,2005:1-3.
[4]ISO 16604.Clothing for Protection against contact with blood and bodyfluids-Determination of resistance of Protective clothing materials to Penetration by bloodborne-Pathogens-Test method using Phi-X174bacterio Phage[S].International Organization for Standardization.2004.
[5]陈敏璠,傅博强,林婧,等.阴沟肠杆菌定量标准物质的研制[J].计量学报,2017,38(5):527-531.Chen M F,Fu B Q,Lin Q,et al.Development of Quantitative Reference Material of Enterobacter Cloacae[J].Acta Metrologica Sinica,2017,38(5):527-531.
[6]薛蕾,林婧,隋志伟,等.大肠杆菌定量检测用标准物质的研制[J].计量学报2015,36(6):652-656.Xu L,Lin Q,Sui Z W,et al.Preparation of Reference Material for Quantitative Detection of Escherichia Coli[J].Acta Metrologica Sinica,2015,36(6):652-656.
[7]沈伟,何静芳,苏怡,等.医用防护服与防护口罩阻隔性能研究[J].中国消毒学杂志,2005,22(4):386-390.Shen W,He J F,Su Y,et al.Study on Barrier Property of Medical Protective Clothing and Protective Mask[J].Chinese Journal of Disinfection,2005,22(4):386-390.
[8]鹿建春,孙振海,李劲松,等.生物防护口罩的研制及其防护效果评价[J].中国消毒学杂志,2004,21(3):189-192.Lu J C,Sun Z H,Li J S,et al.Development and Protective Efficacy Evaluation of BIO-Protective Respirator[J].Chinese Journal of Disinfection,2004,21(3):189-192.
[9]赵月峨,鹿建春,温占波,等.一种新型高效生物防护口罩的防护性能测试[J].中华预防医学杂志,2007,8(1):27-29.Zhao Y E,Lu J C,Wen Z B,et al.Testing Biological Protection Quality for a New Respirator[J].Chinese Journal of Preventive Medicine,2007,8(1):27-29.
[10]沈恒根,杨磊,刘刚,等.新型医用防护口罩过滤环境气溶胶的性能[J].第二军医大学学报,2003,24(6):629-631.Shen H G,Yang L,Liu G,et al.Performance of a new mask material in filtering ambient aerosols for medical staff[J].Academic Journal of Second Military Medical University,2003,24(6):629-631.
[11]朱孟府,龚承元,苏建勇,等.平面型荷电防病毒口罩的结构及性能评价[J].生物防护防疫装备,2005,26(4):29-30.Zhu M F,Dou C Y,Su J Y,et al.The Structure and performances of the plane-type charge-modified viruspreventive mask[J].Biological Protection and Epidemic Prevention Equipment,2005,26(4):29-30.
[12]GB/T 6379.2-2004测量方法与结果的准确度(正确度与精密度)第2部分:确定标准测量方法重复性与再现性的基本方法[S].
[13]ISO Guide 35:2006 Rerence materials-General and statistical principles for certification[S]
[14]JJF 1343-2012标准物质定值的通用原则及统计原理[S].
[15]吴谦,黄晓蓉,王晶,等.鸡肉中单核细胞增生李斯特氏菌标准物质的研制[J].计量学报,2010,31(5A):9-13.Wu Q,Huang X R,Wang J,et al.Preparation of Standard Substance for Listeria Monocytogenes in Chicken[J].Acta Metrologica Sinica,2010,31(5A):9-13.