【摘要】 [目的]调研河南省AIDS筛查实验室工作的现实状况,发掘技术上及管理中存在的问题,以提高检测质量。[方法]抽取河南省108家艾滋病筛查实验室,对质量保证、实验室规范化建设、人力资源及培训情况、SOP文件、实验室质量控制等8个方面进行现场调查,以统一的调查评分表打分,统计分析分数。[结果]按评分标准统计,本次调查的实验室中3.7%(4/108)不合格(≤60分),5.6%(6/108)合格(61～80分),40.7%(44/108)良好(81～90分),50.0%(54/108)优秀(≥91分)。不规范的项目主要为:76.9%(83/108)质控图签字不规范,48.2%(52/108)无失控分析及纠错记录,45.4%(49/108)仪器校准不规范,34.3%(37/108)未规范使用外部质控品,31.5%(34/108)的ELISA原始记录不规范,各实验室对发现的问题立即进行整改。[结论]河南省AIDS筛查实验室存在一些问题,应加强实验室技术培训和质量控制方面的工作。更多还原

【Abstract】 [Objective] To investigate the present status of the AIDS antibody screening laboratory in Henan province,so as to find out the problems in operational techniques and management,and to improve the testing level and quality.[Methods] 108 screening laboratories were selected,and a spot investigation was made on the following aspects: Quality guarantee,construction of standard screening laboratories,personnel and training,standard operation procedure(SOP) documents and laboratories quality control,etc.Based on the uniform evaluation form,scores were given and analyzed statistically to find out the problems.[Results] According to the standard grading,among 108 laboratories in the survey,3.7%(4/108) laboratories were unqualified(≤60 points),5.6%(6/108) laboratories were qualified(61-80 points),40.7%(44/108) laboratories were good(81-90 points),and 50.0%(54/108) laboratories were excellent(≥91 points).The insufficiencies mainly in-cluded: 76.9%(83/108) laboratories were nonstandard in signatures on the chart for controlling quality,48.2%(52/108) laboratories were nonstandard in the uncontrollable documentary record in quality,45.4%(49/108) laboratories were of non-standard calibration,34.3%(37/108) laboratories were nonstandard in using the serum showing HIV-Antibody feeble mascu-line and 31.5%(34/108) laboratories were nonstandard in the documentary record of ELISA.The nonstandard laboratories had make improvement on their problems according to the specialists’ suggestions.[Conclusion] There are some problems in some AIDS antibody screening laboratories,so the medical personals need to reinforce the training of standardized operation procedure and quality control in HIV inspection.更多还原