摘要
目的 评估开展梅毒反应性献血者确证工作的可行性。方法 采用梅毒螺旋体颗粒凝集试验(TPPA)及免疫印迹法(WB)对ELISA检测抗-TP反应性献血者标本进行确证试验,对2种确证结果为阴性、可疑或结果不一致者行追踪检测并进行结果对比;同时以2种确证方法结果为标准,采用受试者工作特征曲线(ROC曲线)评估对比A、B、C 3种筛查试剂及其组合的分析指标值。结果 1)223份ELISA抗-TP反应性标本(其中双ELISA试剂反应性124份,单ELISA试剂反应性99份)经TPPA确证阳性率为57.40%、WB确证阳性率38.57%(其中双ELISA试剂反应性标本经TPPA确证阳性率为89.52%、WB确证阳性率为52.42%,单ELISA试剂反应性标本经TPPA确证阳性率为17.17%,WB确证阳性率为21.21%);TPPA确证阴性率为35.43%,WB确证阴性率为42.60%(其中双ELISA试剂反应性标本TPPA确证阴性率6.45%、WB确证阴性率29.84%,单ELISA试剂反应性标本TPPA确证阴性率71.72%、WB确证阴性率58.59%)。经Kappa检验,2种方法确证结果一致性不高,特别是单ELISA试剂反应性标本;2)献血者追踪成功36名,其中17名(47.22%)确证检测结果有转变,但转变无规律;3)以TPPA、WB确证结果为标准对双ELISA试剂反应性标本抗-TP筛查S/CO值进行ROC曲线分析,ELISA筛查试剂A/B、A/C组合时,A试剂最佳S/CO值分别为1.815、5.73和10.205、16.165。结论 TPPA和WB对ELISA抗-TP反应性献血者标本确证结果一致性较差,追踪确证结果转归也不明确;ROC曲线最佳S/CO阈值分析受确证方法、筛查试剂组合影响,ELISA抗-TP反应性献血者的结果确证存在一定困难。
Objective To evaluate the feasibility of confirming syphilis reactive blood donors.Methods The serum of donors with anti-TP reaction by ELISA were confirmed by treponema pallidum particle agglutination(TPPA) and Western blotting(WB).The results of two confirmation methods that were negative,suspicious or inconsistent were followed up and compared.At the same time,the analytical index values of the screening reagent A,B and C and their combinations were evaluated and compared using the the receiver operating characteristic curve(ROC curve) based on the results of the two confirmation methods.Results The positive rate of 223 ELISA anti-TP reactive samples(including 124 double-reagent ELISA reactive samples and 99 single-reagent ELISA reactive samples) was 57.40% confirmed by TPPA and 38.57% confirmed by WB(89.52% vs 17.17% by TPPA and 52.42% vs 21.21% by WB for double-reagent and single-reagent ELISA reactive samples).The confirmed negative rate of TPPA was 35.43% and that of WB was 42.60%(6.45% vs 71.72% of TPPA and 29.84% vs 58.59% of WB for double-reagent and single-reagent ELISA reactive samples).According to Kappa test,the confirmed results between the two methods were not consistent,especially for those single-regent ELISA reactive samples.Thirty six cases were followed up successfully,of which 17(47.22%) confirmed changes in the test results but the changes were irregular.Based on the confirmed results of TPPA and WB,the ROC curve analysis was performed on the anti-TP screening S/CO values of double-reagent ELISA reactive samples.When combining ELISA screening reagents as A/B and A/C,the optimal S/CO values of reagent A were 1.815,5.73 and 10.205,16.165,respectively.Conclusion TPPA and WB have poor consistency in the confirmation of ELISA anti-TP reactive blood samples,and the outcome of follow-up confirmation is unclear.The S/CO threshold of ROC curve is affected by the combination of confirmatory screening reagents,and it is difficult to confirm the results of ELISA anti-TP reactive blood donors.
作者
邹姣丽
陈庆恺
袁秋婷
邓妙玲
潘俊均
苏婉兰
魏润葵
何子毅
ZOU Jiaoli;CHEN Qingkai;YUAN Qiuting;DENG Miaoling;PAN Junjun;SU Wanlan;WEI Runkui;HE Ziyi(Dongguan Blood Center,Dongguan 523000,China;Kanghua Hospital of Dongguan)
出处
《中国输血杂志》
CAS
2024年第7期790-796,共7页
Chinese Journal of Blood Transfusion
基金
东莞市社会发展科技项目(20211800905402)。
