双检方法联合检测在口岸梅毒监测中的应用

Application of Double Detection Method in Syphilis Surveillance at Port

本文以辽宁口岸地区2017—2023年出入境人员样品中疑似梅毒的血液样品525例作为研究对象,探讨单一方法与双检方法联合检测的差异,以梅毒螺旋体明胶凝集试验(Treponema Pallidum Particle Agglutination Test,TPPA)为标准,采用甲苯胺红不加热血清学试验(Tolulized Red Unheated Serum Test,TRUST)、TPPA、梅毒胶体金试验(Colloidal Gold Test for Syphilis,SYP)、酶联免疫吸附试验(Enzyme-linked Immunosorbent Assay,ELISA)单一方法和双检方法联合检测。分析结果显示,单一方法中,TRUST敏感度20.95%、特异度99.05%;SYP敏感度91.67%,特异度69.52%;ELISA敏感度99.52%,特异度29.52%;双检方法联合检测中,TRUST+TPPA灵敏度20.95%、特异度100%、阳性检出率16.76%、漏检率为79.05%;SYP+TPPA灵敏度91.67%、特异度100%、阳性检出率73.33%、漏检率8.33%;ELISA+TPPA灵敏度99.52%、特异度100%、阳性检出率79.62%、漏检率0.48%。结果显示,在单一方法中,SYP与ELISA方法灵敏度优于TRUST(p<0.05);SYP、TPPA符合率与ELISA吸光度值有关,随着吸光度值增加符合率升高。双检方法联合检测中,SYP+TPPA、ELISA+TPPA与TRUST+TPPA比较阳性检出率与漏检率均有统计学意义(p<0.05)。双检方法联合检测可以有效提高特异度,降低假阳性率;ELISA+TPPA方法优于其他方法,漏检率低且试剂成本低、可批量检测、检测结果可溯源,适用于口岸出入境人群大批量样本的自动化监测。

This study examines 525 suspected syphilis blood samples from entry-exit personnel at Liaoning port from 2017 to 2023,focusing on the comparative analysis between single and double detection methods.With the Treponema Pallidum Particle Agglutination Test(TPPA)as the reference standard,the single and double detection methods included Tolulized Red Unheated Serum Test(TRUST),TPPA,Colloidal Gold Test for Syphilis(SYP),Enzyme-linked Immunosorbent Assay(ELISA).In the single detection method,the findings indicated that the sensitivity and specificity of TRUST were 20.95%and 99.05%,respectively;SYP demonstrated a sensitivity of 91.67%and a specificity of 69.52%;ELISA showed a high sensitivity at 99.52%but a low specificity of 29.52%.In the double detection method,when TRUST was combined with TPPA,the sensitivity was 20.95%,specificity reached 100%,with a positive detection rate of 16.76%and a missed detection rate of 79.05%.Conversely,the combination of SYP and TPPA exhibited a sensitivity of 91.67%,a specificity of 100%,a positive detection rate of 73.33%,and a missed detection rate of 8.33%.The ELISA combined with TPPA showed a sensitivity of 99.52%,a specificity of 100%,a positive detection rate of 79.62%,and a missed detection rate of 0.48%.The study concludes that,in the single detection method,the sensitivity of SYP and ELISA surpasses that of TRUST(p<0.05);the concordance rate between SYP and TPPA correlates with the ELISA absorbance value,with the rate increasing as the absorbance value rises.The combined detection using SYP+TPPA,ELISA+TPPA,and TRUST+TPPA significantly differs in terms of positive and missed detection rates(p<0.05).The double detection method enhances specificity and reduces the incidence of false positives.The ELISA+TPPA method is particularly advantageous,offering a low detection rate,minimal reagent costs,and the capability for batch and traceable detection results,making it suitable for automated surveillance of large volumes of entry-exit population samples at ports.