河南省艾滋病筛查实验室质量控制现状分析

目的了解河南省艾滋病（AIDS）筛查实验室质量控制现状,发现并解决技术及管理中存在的问题,提高检测质量。方法以疫情较重县区和工作量较大的实验室为首选,兼顾民办医疗机构及其他机构的实验室,对质量保证及质量控制情况进行现场调查,统计分析存在的问题,提出合理建议。结果共调查了108个实验室,发现45.4%（49/108）的实验室无仪器设备校准,31.5%（34/108）的酶联免疫吸附试验（ELISA）的原始记录不规范,76.9%（83/108）无质控图绘制者及实验室负责人签字,48.2%（52/108）无失控分析及纠错记录,34.3%（37/108）未每次实验使用外部质控品。各实验室对发现的问题进行限期整改。结论河南省AIDS筛查实验室总体运行良好,应加强实验室技术培训及质量控制方面的工作,提高工作质量。

Quality control of laboratories working for AIDS antibody screening tests

Objective To investigate the present status of quality control of laboratories working for AIDS antibody screening tests, find out technical and managerial problems and upgrade the quality of HIV testing in Henan province. Methods Screening laboratories from the counties with severe HIV prevalence and laboratories with larger working loads were selected as the first choice, while laboratories under private or other medical institutions were also included. The practices of quality assurance and quality control in the selected laboratories were surveyed on spot, problems identified were analyzed statistically and appropriate suggestion were made accordingly. Results Of the 108 selected laboratories, 45.4% （49/108） lacked instruments for standard calibration, 31.5% （34/108） had poor documentary records of ELISA, 76.9% （83/108） released the test results without signatures by the designer of quality control chart or laboratories＇ responsible persons, 48.2% （52/108） lacked record of analyzing causes of poor quality control and the way to improve it, 34.3% （37/108） failed to use reference agents for external quality control in every test. None of the laboratories were obliged to correct any identified problems within a definite time frame. Conclusion The laboratories working for AIDS screening tests in Henan province have displayed generally good performance, but technical training and quality control in these laboratories should be strengthened and their working quality be improved.