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作 者:王靖[1] 李小全 刘敏[1] 杨志立 徐植 赵雅淳 王丽[1] WANG Jing;LI Xiao-quan;LIU Min;YANG Zhi-li;XU Zhi;ZHAO Ya-chun;WANG Li(The First Affiliated Hospital of Henan University,Kaifeng475000)
出 处:《实用中西医结合临床》2024年第10期1-5,共5页Practical Clinical Journal of Integrated Traditional Chinese and Western Medicine
基 金:河南省开封市科技攻关项目(编号:2303017)。
摘 要:目的 以梅毒螺旋体凝集试验(TPPA)作为确认试验,确立酶联免疫吸附试验(ELISA)法S/CO值与梅毒阳性最佳截断值,减少不必要的TPPA确认重复。方法 选取2022年10月至2023年10月在医院进行梅毒螺旋体(TP)抗体检测的血清标本22 500例,以ELISA法为梅毒初次筛查试验,采用TPPA和甲苯胺红不加热血清试验(TRUST)对所有反应结果进行复核和确认。分析376例有反应性标本中的S/CO值与TPPA的关系,使用受试者操作特征曲线(ROC)确定ELISA法S/CO值与TPPA阳性最佳截断值。根据S/CO最佳截断值,比较梅毒不同反式筛查策略需要TPPA确认的标本数量。结果 当S/CO≥6.6时,TPPA与ELISA结果一致,特异性和阳性预测值均为100.00%,S/CO=6.6时为最佳截断值;使用欧洲疾病预防与控制中心(ECDC)策略时,376例筛查反应性样本(100.00%,376/376)需TPPA确认;使用美国疾病控制与预防中心(CDC)策略时,TPPA还需确认217例(57.71%,217/376);本研究只有122例(32.45%,122/376)需进行TPPA确认。结论 采用ELISA法梅毒反式筛查策略不受TRUST结果影响,当S/CO≥6.6时不需要进行TPPA确认,与ECDC和CDC反式策略相比,本研究有67.55%的筛查反应样本不必进行TPPA确认,经济且节约时间和人力。Objective Treponema Pallidum particle agglutination(TPPA)as a confirmatory test to establish the best cut-off value of the enzyme-linked immunosorbent assay(ELISA)method S/CO value with syphilis positivity to reduce unnecessary duplication of TPPA confirmation.Methods ELISA was used as the initial syphilis screening test,and the toluidine red unheated serum test(TRUST)and TPPA tests were used to review and confirm all reactive results.The relationship between S/CO values and TPPA in 376 reactive specimens was analyzed to determine the best cut-off values for S/CO values and TPPA positivity by ELISA using the subject operating characteristic curve(ROC).The number of TPPA confirmations required for different inverse screening strategies for syphilis was compared according to the S/CO optimal cut-off values.Results When the S/CO value was≥6.6,TPPA was consistent with ELISA results with a specificity and positive predictive value of 100.00%,and an S/CO value of 6.6 was the optimal cut-off value.TPPA confirmation was required for all 376 screening reactive samples(100.00%,376/376)of the European Center for Disease Control and Prevention(ECDC)algorithm.The US Centers for Disease Control and Prevention(CDC)algorithm TPPA confirmed 217 patients(57.71%,217/376).TPPA confirmation was required in 122 cases(32.45%,122/376)in this study.Conclusions The ELISA syphilis trans screening strategy is used,independent of TRUST results,and TPPA confirmation is not required when the S/CO value is≥6.6.Compared with the ECDC and CDC trans strategy,67.55%of the screening response samples in this study did not require TPPA confirmation,which is economical and saved time and workload.
分 类 号:R759.1[医药卫生—皮肤病学与性病学]
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