全国结核病实验室网络痰涂片镜检室间质量保证结果分析

Study of External Quality Assurance of Sputum Smear Microscopy in Tuberculosis Laboratories

目的分析《中国结核病防治规划痰涂片镜检标准化操作及质量保证手册(2008版)》实施后全国结核病实验室痰涂片镜检盲法复检实施情况。方法收集2009年和2010年全国31个省(自治区、直辖市)县区级结防机构痰涂片镜检实验室开展盲法复检资料,分析全国盲法复检实施情况。结果 2009、2010年全国接受盲法复检实验室数量的比例分别为99.3%(2557/2574)和98.3%(2535/2578)。2009年和2010年发生2个及以上低假阳性/阴性结果的实验室比例为5.3%(136/2557)和3.6%(91/2535),而发生高假阳性/阴性结果的实验室比例为4.0%(103/2557)和4.0%(101/2535)。结论全国结核病实验室痰涂片镜检盲法复检覆盖率总体较高,出现定性错误比例较少,为全国结核病防治规划提供了较高质量痰涂片镜检检测服务。但仍应重点关注出现定性错误的实验室,避免再次发生错误。

Objective To analyze the implementation of external quality assurance of sputum smear microscopy in the national TB laboratory network after the implementation of TB Control Program Standardized Operation Procedure and Quality Assurance Sputum Smear Microscopy Manual （2008 Edition）. Methods Smear microscopy blinded rechecking data were collected from 31 provinces in 2009 and 2010 to analyze the coverage rate of blinded rechecking as well as quality of smear microscopy work. Results The coverage rates of smear microscopy blinded - rechecking were 99.3% （2557/2574） and 98.3% （2535/2578） in 2009 and 2010 respectively. The proportions of LFP/LFN laboratories were 5.3% （136/2557） and 3.6% （91/2535） , HFP/HFN laboratories were 4.0% （ 103/2557 ） and 4.0% （101/2535） in 2009 and 2010, respectively. Conclusion The coverage rate of blinded rechecking was high among district level TB la- boratories, and the proportion of laboratories occurring qualitative error was low, indicating that district laboratories provided a high quality smear microscopy services for the National TB Control Program. However, the laboratories having quality error need to be focused.