无偿献血者梅毒ELISA不合格结果与TPPA确证试验的对比分析  

Comparative analysis of unqualified results of syphilis ELISA test and TPPA confirmation test among voluntary blood donors

作　　者：魏旖辉 王艺芳[1] 陈明军[1] 涂甜甜 吕永磊[1] 王淑敏 赵磊[1] WEI Yihui;WANG Yifang;CHEN Mingjun;TU Tiantian;LV Yonglei;WANG Shumin;ZHAO Lei(Henan Red Cross Blood Center,Henan Blood Safety Research Institute.Zhengzhou,450000,China)

机构地区：[1]河南省红十字血液中心河南省血液安全研究所,郑州450000

出　　处：《临床血液学杂志》2025年第2期122-125,130,共5页Journal of Clinical Hematology

基　　金：河南省医学科技攻关计划联合共建项目(No:2018020586)。

摘　　要：目的:通过对无偿献血者梅毒酶联免疫吸附试验(enzyme linked immunosorbent assay, ELISA)结果不合格标本的螺旋体颗粒凝集试验(treponema pallidum particle assay, TPPA)确证比对分析,探究ELISA结果S/CO值与梅毒确证试验结果的相关性以及灰区设置的必要性和合理性,进而提高血液筛查的有效性和供血安全。方法:收集郑州地区无偿献血者510份ELISA检测不合格标本,采用TPPA进行梅毒螺旋抗体的阳性确证。结果:(1) ELISA试验检测不合格标本510份,经TPPA试验确证阳性标本223份,阴性标本287份,ELISA试验假阳性率为56.27%。(2)初次ELISA试验双试剂反应性标本S/CO值均大于5,其阳性符合率为98.87%(175/177);在TPPA试验确证为阳性的223份标本中,有211份ELISA双试剂为反应性,有12份ELISA单试剂为反应性;ELISA双试剂检测结果均在灰区的TPPA确证试验均为阴性;其中一种ELISA试剂检测结果为阴性,另一种ELISA试剂检测结果在灰区的TPPA确证试验均为阴性;且ELISA试验S/CO值大小与TPPA确证阳性符合率结果具有相关性。(3)初次献血人群的阳性符合率显著高于重复献血人群TPPA确证阳性符合率(χ^(2)=19.707,P<0.05)。(4)从性别分布中分析,男性梅毒TPPA阳性符合率和女性TPPA阳性符合率接近(χ^(2)=0.011,P=0.916,P>0.05)。结论:通过对梅毒螺旋体检测试验的分析,存在部分假阳性的问题,为了尽可能地避免因假阳性造成血源的浪费,可考虑对血液梅毒ELISA不合格的标本进行确证试验的检测,同时合理地设置灰区范围,提高血液安全。Objective:To explore the correlation between enzyme-linked immunosorbent assay(ELISA)results and syphilis confirmatory test results and the necessity and rationality of gray zone setting by the confirmatory comparison analysis of the spirochetal particle agglutination test(treponema pallidum particle assay,TPPA)of unpaid blood donors with the results of syphilis ELISA results,improve the effectiveness of blood screening and the safety of blood supply.Methods:A total of 510 unqualified specimens from voluntary blood donors in Zhengzhou were collected,and TPPA was used to confirm the positive of syphilis antibody.Results:OThere were 51o unqualified specimens detected by ELISA experiment,223 positive specimens and 287 negative specimens confirmed by TPPA test,and the false positive rate of ELISA experiment was 56.27%.The S/CO values of the two-reagent reactive specimens in the initial ELISA experiment were all greater than 5,and the positive coincidence rate was 98.87%(175/177).Among the 223 specimens confirmed positive by TPPA test,211 were reactive with ELISA double reagent and 12 were reactive with ELISA single reagent.The results of ELISA double reagent detection were all negative in the TPPA confirmatory experiment in the gray area.One of the ELISA reagents was negative,and the other ELISA reagent was negative in the TPPA confirmatory test in the gray area.Moreover,the S/CO value of ELISA experiment was correlated with the positive coincidence rate of TPPA.The positive coincidence rate of the first blood donation group was significantly higher than that of the repeat blood donation group(χ^(2)=19.707,P<0.05).@From the analysis of gender distribution,the positive coincidence rate of TPPA in male syphilis and in female syphilis were similar(=0.01l,P=0.916,P>0.05).Conclusion:Through the laboratory analysis of treponema pallidum detection experiments,there were some false positive problems.In order to avoid the waste of false positive blood sources as much as possible,it is possible to consider targeted confirmati

关 键 词：梅毒酶联免疫吸附试验 螺旋体颗粒凝集试验 无偿献血者 梅毒螺旋体 

分 类 号：R446.11[医药卫生—诊断学]