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目的了解上海市各级医疗机构实验室开展梅毒螺旋体血清学检测质量及变化趋势。方法周期性地将一组样本发送到各实验室进行检测,比较每一实验室的结果与同组的其他实验室的结果/靶值,及时将比较的情况反馈给参与的实验室。结果2004年至2007年共进行了8次梅毒螺旋体血清学室间质量评价(EQA)。平均回报率超过97%。梅毒螺旋体筛查试验总合格率最高的为2004年(90.8%),最低的为2005年(76.1%);分析不同靶值样本结果,阴性和中、高滴度样本的合格率基本在80%,临界和弱阳性样本在32.7%和73.3%;1∶16或以上滴度的样本检测结果的变异系数(CV)值在10%或以下,而弱阳性样本的CV值超过90%;筛查试验的合格率按降序排列为二级医院(85.3%)、三级医院(83.5%)、民营医院(81.0%)和一级医院(76.6%)。4年中梅毒确诊试验总体合格率接近98%;各级医院分组的合格率差异不大。结论弱阳性样本筛查试验结果的CV值是影响整体EQA合格率的主要因素,不同级别的医疗机构,存在着检测质量的总体差异。需要及时调整专业管理模式,加强岗位培训的力度,探索提高检测质量的方法。
Objective To understand the quality and trend of serological tests for Treponema pallidum in laboratories of medical institutions at all levels in Shanghai. Methods Periodically, a group of samples was sent to each laboratory for testing. The results of each laboratory were compared with the results of other laboratories in the same group, and the results were compared and reported to the participating laboratories in time. Results From 2004 to 2007, eight serological inter-laboratory quality assessments of Treponema pallidum (EQA) were performed. Average return over 97%. Treponema pallidum screening test with the highest total passing rate in 2004 (90.8%), the lowest for 2005 (76.1%); analysis of different target sample results, negative and middle and high titer samples pass rate of 80% , With critical and weakly positive samples at 32.7% and 73.3%; CVs at 10% or less for samples with 1:16 or higher titer and CV values for weakly positive samples exceeding 90%; Screening The passing rates of the tests were ranked as Grade-II hospitals (85.3%), Grade-III hospitals (83.5%), private hospitals (81.0%) and Grade-I hospitals (76.6%) in descending order. 4 years syphilis diagnosis test overall pass rate close to 98%; at all levels of hospital group pass rate is not significant. Conclusion The CV value of screening test results of weakly positive samples is the main factor affecting the overall EQA pass rate. There is an overall difference in the quality of testing at different levels of medical institutions. Need to promptly adjust the professional management mode, strengthen job training efforts to explore ways to improve the quality of testing.