2013—2018年北京市艾滋病筛查实验室室间比对结果分析

Analysis of inter-laboratory comparison results of AIDS screening tests in Beijing, 2013-2018

目的了解北京市艾滋病筛查实验室室间比对能力差异,评价艾滋病筛查实验室检测质量。方法制备不同属性的随机盲样,发放给北京市各艾滋病筛查实验室。按照《全国艾滋病检测技术规范》和试剂盒说明书进行艾滋病筛查实验。用SPSS19.0进行数据汇总、整理与统计分析。结果2013—2018年北京市艾滋病筛查实验室室间比对参加率100.0%,总体合格率为98.8%~100.0%,绝大多数实验室能够提供完整规范的原始记录、质控图、复检化验单等。部分实验室存在临界值计算和质控图绘制错误情况的发生。结论北京市艾滋病筛查实验室检测结果总体上准确可靠,但是部分实验室仍存在一定的问题,反映出实验室日常质量管理及人员更换的技术交接不到位,提示应加强实验室督导管理及技术培训。

Objective To understand the differences of inter-laboratory comparison results of acquired immune deficiency syndrome (AIDS) screening tests in Beijing and to evaluate the testing quality in AIDS screening laboratories. Methods Randomized blind samples of HIV antibody with different titers were prepared and distributed to each AIDS screening laboratory in Beijing. Screening tests of AIDS were performed according to "National Guideline for Detection of HIV/AIDS" and the manuals of test kits. The data were summarized and analyzed by SPSS 19.0 software. Results From 2013 to 2018, 100.0% of the AIDS screening laboratories participated in the inter-laboratory comparisons. The overall qualified rates were 98.8%-100.0%. Most of the laboratories provided accurate testing results with complete and standardized original records, quality control charts and retesting sheets. Errors in calculation of cut-off values and in drawing quality control charts were also found in some laboratories. Conclusions The test results of AIDS screening laboratories in Beijing were generally accurate and reliable. However, there were still some problems in some laboratories, indicating that the daily quality management and technical handover of personnel replacement in laboratories were not in place. This also suggested that laboratory supervision management and technical training should be strengthened.