2012-2021年江苏省梅毒血清学检测室间质评结果分析  

Analysis of Syphilis Serology Testing on the External Quality Assessment in Jiangsu Prov⁃ince from 2012 to 2021

作　　者：李孟兰 吴玉璘 封婕 黄丽丽 张瑞金 周青 刘帅妹 林宁 LI Menglan;WU Yulin;FENG Jie;HUANG Lili;ZHANG Ruijin;ZHOU Qing;LIU Shuaimei;LIN Ning(Jiangsu Health Development Research Center,NHC Key Laboratory of Contraceptives Vigilance and Fertility Surveil-lance,Jiangsu Provincial Medical Key Laboratory of Fertility Protection and Health Technology Assessment,Nanjing,Jiangsu,210036)

机构地区：[1]江苏省卫生健康发展研究中心、国家卫生健康委避孕药具警戒与生育力监测重点实验室、江苏省生育力保护与卫生技术评估重点实验室,江苏南京210036

出　　处：《江苏卫生事业管理》2024年第8期1109-1112,共4页Jiangsu Health System Management

基　　金：江苏省卫生健康委科研项目(M2020101);江苏省科教能力提升工程(ZDXYS202210)。

摘　　要：目的:回顾2012-2021年江苏省免费孕前优生健康检查项目梅毒血清学检测室间质评结果,分析基层妇幼保健机构梅毒血清学检测现状及发展趋势。方法:每年开展2次、每次发放5份室间质评样本,各参评单位在规定时间内检测、回报结果后由本中心进行统计分析。结果:2012-2021年梅毒血清学检测室间质评的满分率、合格率分别从66.32%、95.79%提高至100.00%、100.00%。CLIA的使用率从1.05%逐渐上升至25.29%,RPR和TRUST的使用率分别从29.47%、14.74%下降至0.00%、5.75%。各检测方法的结果符合率最高均达100.00%,其中ELISA和CLIA的结果符合率较高且较稳定,RPR和TRUST的结果符合率除2017年第一次外均在93.00%以上,TPPA和其他组的结果符合率相对波动较大。ELISA和CLIA的结果符合率高于TPPA,差异具有统计学意义(P<0.05)。RPR和TRUST的结果符合率比较差异无统计学意义(P>0.05)。结论:江苏省基层妇幼保健机构梅毒血清学检测能力总体较为理想,不同检测方法之间的结果符合率存在一定差异,实验室在选择梅毒血清学检测方法时应加以考虑。Objective:The present situation and development trend of syphilis serological testing in primary maternal and child health care institutions were analyzed by reviewing the external quality assessment results of syphilis in the free pre-pregnancy health examination in Jiangsu province from 2012 to 2021.Methods:The external quality assessment were carried out twice a year and five samples were distributed each time.The participating units tested and reported the results by the deadline.Then the results of the exter⁃nal quality assessment of all participating units were collected and analyzed.Results:From 2012 to 2021,the full mark rate and quali⁃fied rate of syphilis serological testing of external quality assessment increased from 66.32%and 95.79%to 100.00%and 100.00%re⁃spectively.The usage rate of CLIA improved from 1.05%to 25.29%,and the usage rate of RPR and TRUST decreased from 29.47%and 14.74%to 0.00%and 5.75%,respectively.The highest coincidence rate of all detection methods were up to 100.00%,and the coin⁃cidence rate of ELISA and CLIA was high and stable.Except for the first time in 2017,the coincidence rates of RPR and TRUST were both above 93.00%,While the coincidence rate of TPPA and other groups fluctuated greatly.The coincidence rates of ELISA and CLIA were significantly higher than that of TPPA(P<0.05).But there was no significant difference in the coincidence rate between RPR and TRUST(P>0.05).Conclusion:The serological detection capacity of syphilis in primary maternal and child health care institu⁃tions in Jiangsu Province is generally ideal.There are some differences in the result coincidence rate between different detection meth⁃ods,which should be taken into consideration in the selection of syphilis serological detection methods.

关 键 词：梅毒 室间质评 血清学检测 

分 类 号：R197.39[医药卫生—卫生事业管理]