Synergistic diagnostic efficacy of magnetic microparticle chemiluminescence and TPPA co-testing in syphilis screening for women and children and its value in maternal-fetal blocking
妇幼人群梅毒筛查中磁微粒化学发光法与TPPA联检的协同诊断效能及母婴阻断价值

摘要

目的 探讨磁微粒化学发光法（CMIA）与梅毒螺旋体颗粒凝集试验（TPPA）联合检测在妇幼人群梅毒血清学诊断中的应用效能，及其在梅毒母婴阻断中的临床价值。方法 选取某妇幼保健院2023年1月-2025年12月收治的180例研究对象，其中孕妇100例，新生儿80例，回顾性队列研究。以CMIA为初筛方法、TPPA为确证方法，联合甲苯胺红不加热血清试验（TRUST）半定量检测，对比诊断效能，分析孕妇不同孕周梅毒阳性率变化、新生儿检测符合率及母婴传播危险因素。结果 100例孕妇中，CMIA初筛阳性22例，经TPPA确证阳性20例，CMIA灵敏度100%，假阳性2例；TRUST初筛阳性18例，漏诊2例。TPPA总阳性率20.0%，随孕周增加呈阶梯式上升，差异有统计学意义（P<0.05）。80例新生儿中，TPPA阳性8例，与临床确诊先天性梅毒9例的符合率为88.9％。梅毒母婴传播发生率为40.0%(8/20）。单因素分析显示，母亲孕期未治疗或治疗不规范、TRUST初始滴度≥1:16、确诊孕周≥28周为母婴传播可控危险因素（P<0.01）。结论 CMIA联合TPPA检测兼具高灵敏度与高特异性，可有效降低漏诊与假阳性风险，适配妊娠期特殊生理状态。

Abstract

Objective To investigate the application efficacy of magnetic microparticle chemiluminescence assay (CMIA) combined with treponema pallidum particle agglutination test (TPPA) in the serological diagnosis of syphilis among women and children, and to evaluate its clinical value in blocking maternal-fetal transmission of syphilis.
Methods A total of 180 subjects admitted to a maternal and child health hospital from January 2023 to December 2025 were selected, including 100 pregnant women and 80 newborns, in a retrospective cohort study. CMIA was used as the primary screening method, TPPA as the confirmatory method, and toluidine red unheated serum test (TRUST) semi-quantitative detection in combination. Diagnostic efficacy was compared, and changes in syphilis positivity rates in pregnant women at different gestational weeks, newborn testing concordance, and maternal-fetal transmission risk factors were analyzed.
Results Among 100 pregnant women, 22 tested positive by CMIA screening, and 20 were confirmed positive by TPPA. CMIA sensitivity was 100%, with 2 false positives; TRUST initial screening detected 18 positives, missing 2 cases. The overall TPPA positivity rate was 20.0%, showing a stepwise increase with gestational age, which was statistically significant (P<0.05). Among 80 newborns, 8 were TPPA positive, with a concordance rate of 88.9% compared to 9 clinically confirmed cases of congenital syphilis. The maternal-fetal transmission rate of syphilis was 40.0% (8/20). Univariate analysis indicated that maternal untreated or improperly treated syphilis during pregnancy, TRUST initial titer ≥1:16, and gestational age at diagnosis ≥28 weeks were controllable risk factors for maternal-fetal transmission (P<0.01).
Conclusion   CMIA combined with TPPA testing offers both high sensitivity and specificity, effectively reducing the risk of missed diagnosis and false positives, making it suitable for the special physiological state of pregnancy.