摘要
目的回顾全国基层医疗机构实验室参加室间质量评价情况，分析梅毒各检测方法间的差异，探讨影响基层实验室梅毒血清学检测能力的因素，促进实验室质量和能力的不断提升。方法自2011至2016年每年进行1～2次室间质量评价，每次发放5份质评样本；各参评机构按要求在规定时间内检测，并回报检测结果、检测方法、仪器和试剂等信息；经汇总后统计分析各实验室检测结果。结果参评基层医疗机构梅毒的检测方法主要有酶联免疫吸附试验（ELISA）、胶体金法、梅毒螺旋体颗粒凝集试验（TPPA）、快速血浆反应素试验（RPR）、甲苯胺红不加热血清试验（TRUST）、化学发光免疫分析法等，对各方法在2011至2016年间的合格率和阴阳性符合率分别进行分析。6年间不同检测方法梅毒血清学检测结果的合格率不尽相同，胶体金法的合格率从2011年的67．78％升至98．89％；TPPA法的合格率从2011年的27．27％升至100％。梅毒螺旋体特异性检测方法和非梅毒螺旋体特异性抗体检测方法的阴阳性符合率变化较明显。TPPA法阴性符合率最低为9．09％，最高为100％，阳性符合率由54．55％升高到100％；TRUST法阴性符合率从78．95％升至100％，自2012年后每次波动在±10％以内。结论梅毒血清学检测不同方法间存在差异性，随着该项目室间质评在各基层妇幼医疗机构的开展，各方法的合格率和阴阳性符合率均有不同程度地提高。
Objective To compare the accuracy of different methods by reviewing syphilis serologic screening external quality assessment （EQA） data of Chinese primary health care institutions. Methods The EQA was based on one or two distinct shipments from 2011 to 2016. Each shipment consisted of five serum samples. The laboratories performed the EQA and sent back the results by the deadline. The results were analyzed using the standard procedures and methods. Results Six different methods were used for syphilis serologic screening： enzyme linked immunosorbent assay, colloidal gold method, Treponema pallidum particle agglutination （TPPA） test, rapid plasma reagin card test, toluidine red unheated serum reagin test and chemiluminescence immunoassay. From 2011 to 2016, the qualified rate of the colloidal gold method and TPPA had improved from 67.78% to 98.89% and 27.27% to 100%, respectively. The positive coincidence rate of TPPA had changed from 54.55% to 100%. The negative coincidence rate of TRUST had changed from 78.95% to 100%. Conclusions There were differences between different methods of syphilis serological detection. With the implementation of the EQA performance, the qualified rate, positive coincidence rate, and negative coincidence rate were improved in the primary maternal and child health care institutions.
出处
《中华医学杂志》
CAS
CSCD
北大核心
2017年第36期2844-2847,共4页
National Medical Journal of China
基金
北京市医管局首届登峰人才计划（DFL20150701）
关键词
梅毒
质量保证
卫生保健
质量控制
Syphilis
Quality assurance, health care
Quality control
