化学发光试剂在献血者血液梅毒筛查中的性能评估  

Performance evaluation of a domestic chemiluminesent immunoassay reagent for treponema pallidum antibody screening

作　　者：肖晨 陈剑锋[1] XIAO Chen;CHEN Jianfeng(Department of Clinical Laboratory,Shandong Blood Center,Jinan,25o014,China)

机构地区：[1]山东省血液中心检验科,济南250014

出　　处：《临床血液学杂志》2025年第2期105-108,共4页Journal of Clinical Hematology

基　　金：山东省医药卫生科技发展计划项目(No:202011000934)。

摘　　要：目的:评估某种国产化学发光微粒子免疫分析(CMIA)试剂在献血者血液梅毒螺旋体抗体(TP-Ab)筛查中的性能。方法:使用某种国产CMIA试剂和2种酶联免疫吸附测定(ELISA)试剂,同时检测参考血清盘样本和献血者血浆样本,对检测结果进行比对,对CMIA试剂的TP-Ab筛查性能进行评估。结果:CMIA试剂的灵敏度与2种ELISA试剂接近(99.73%、100.00%、100.00%,P>0.05);CMIA试剂的特异度(84.50%)介于2种ELISA试剂之间(86.05%、80.62%);对于1∶800稀释的TP-Ab阳性血浆样本,CMIA试剂的检出范围(漏检1例)低于2种ELISA试剂(全部检出);检测临界值浓度的样本,CMIA试剂的批内[变异系数(CV) 3.92%]及批间(CV 10.19%)精密度均高于2种ELISA试剂(CV 25.99%、4.35%;CV 36.61%、13.29%)。结论:CMIA试剂用于献血者血液TP-Ab筛查,需要与至少一种ELISA试剂同时使用,以避免假阴性结果,保障血液安全。Objective:This study aims to comprehensively assess the detection performance of a domestically developed chemiluminesent microparticle immunoassay(CMIA)reagent for screening treponema pallidum antibodies(TP-Ab)in blood samples.Methods:Two enzyme-linked immunosorbent assay(ELISA)reagents and one CMIA reagent were utilized to simultaneously conduct treponema pallidum antibody screening performance evaluation by testing reference serum panel samples,followed by in-depth comparative analysis of the results.Results:The sensitivity of the CMIA reagent was 99.73%(371/372),slightly lower than the 100%sensitivity(372/372)observed for both ELISA reagents.The specificity of the CMIA reagent was 84.50%(109/129),positioned between the specificities of the two ELISA reagents,which were 86.05%(111/129)and 80.62%(104/129),respectively.In a series of dilutions of treponema pallidum antibody-positive samples,the CMIA reagent was capable of detecting concentrations as low as 1:800,but it failed to detect samples diluted to 1:800 with HBsAg-positive plasma,while both ELISA reagents could detect all dilutions,including 1:8oo.For samples near the threshold detection limits,the within-batch coefficient of variation(CV)for CMIA was 3.92%,whereas the two ELISA reagents exhibited CVs of 25.99%and 4.35%,respectively.The between-batch CV for CMIA was 10.19%,which was lower than the CVs for the two ELISA reagents,which were 36.61%and 13.29%,respectively.Conclusion:CMIA missed one treponema pallidum antibody-positive sample,indicating a slightly lower detection limit compared to ELISA reagents.It is recommended to use CMIA reagents in conjunction with ELISA reagents when screening blood donors to avoid potential false-negative results.

关 键 词：梅毒螺旋体 献血者 化学发光 酶联免疫吸附测定 

分 类 号：R446.11[医药卫生—诊断学]