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目的分析四川省艾滋病筛查实验室工作质量,查找影响筛查实验室正常运行的危险因素,为进一步加强四川省艾滋病筛查实验室质量控制提供技术参考。方法 2011-2015年开展四川省艾滋病筛查实验室现场考评,每年对每个市州抽查筛查实验室总数的20%,采用统计学Logistic回归分析筛查实验室正常运行的影响因素。结果 2011-2015年共计396家筛查实验室接受现场考评,其中成绩为优秀、良好、合格和不合格的实验室数分别为330家(83.33%)、45家(11.36%)、20家(5.05%)和1家(0.25%);多因素Logistic回归分析发现操作人员资质、资料归档、仪器强检、样品检测规范及流程、外部对照使用、质控图绘制、快速检测外部质控是实验室正常运行的影响因素(P<0.05)。结论艾滋病筛查实验室运行质量受人员素质、硬件质量、实验室检测及实验室质量控制等诸多因素的影响,只有以上因素均达到要求,才能保证艾滋病筛查实验室良好稳定的运行状态。
Objective To analyze the quality of AIDS screening laboratories in Sichuan Province and find out the risk factors that affect the normal operation of screening laboratories and provide technical reference for further strengthening the quality control of AIDS screening laboratories in Sichuan Province. Methods The AIDS screening laboratory in Sichuan Province was evaluated on site during 2011-2015. 20% of the total number of screening laboratories in each city and municipality were sampled every year. Statistical Logistic regression analysis was used to screen the influencing factors of normal laboratory operation. Results A total of 396 screening laboratories from 2011 to 2015 were evaluated on the spot. Among them, 330 (83.33%), 45 (11.36%) and 20 5.05%) and 1 (0.25%). Multivariate logistic regression analysis revealed that the operator qualification, data archiving, instrumental inspection, sample testing specifications and procedures, external control use, quality control charting and rapid test of external quality control Factors affecting the normal operation of the room (P <0.05). Conclusion The operation quality of AIDS screening laboratories is affected by many factors such as the quality of personnel, the quality of hardware, laboratory tests and laboratory quality control. Only when all the above factors meet the requirements can the AIDS screening laboratories be kept in good and stable operating conditions.