Basgalupp Suelen, Dornelles Thayane, Pedrotti Luana, Dos Santos Aniúsca, de Oliveira Cáren, Dos Santos Giovana, de Brito Emerson, Pinheiro Ben Hur, Philippus Ana Cláudia, Bigolin Álisson, Gaspar Pamela Cristina, Moreno Flávia, Pereira Gerson, Tonini Maiko Luis, Wendland Eliana
Hospital Moinhos de Vento, PROADI-SUS, Porto Alegre 90560-030, Brazil.
Department of Community Health, Federal University of Health Science of Porto Alegre, Porto Alegre 90050-170, Brazil.
Diagnostics (Basel). 2025 Jun 6;15(12):1448. doi: 10.3390/diagnostics15121448.
: Syphilis remains a significant public health challenge worldwide. Accurate and efficient diagnostic tools are essential to controlling the spread of the disease. Current diagnostic approaches primarily rely on serologic treponemal tests (TTs) and nontreponemal tests (NTTs). The aim of this study was to evaluate the diagnostic properties of various serological methods for syphilis diagnosis. : Samples were collected from participants of the Health, Information, and Sexually Transmitted Infection Monitoring (SIM study) between March 2020 and May 2023, using convenience sampling at a mobile health unit in Porto Alegre, Brazil. A total of 250 individuals were tested using the point-of-care (POC) lateral flow treponemal test, Venereal Disease Research Laboratory (VDRL) test, Rapid Plasma Reagin (RPR) test, Enzyme-Linked Immunosorbent Assay (ELISA), and hemagglutination assay (TPHA). Of these, 125 participants tested positive for syphilis in the POC screening. Diagnostic properties such as sensitivity, specificity, and predictive values were assessed for the POC test, ELISA, and VDRL test. The TPHA was used as the reference standard for the TT, and the RPR test as the reference standard for the NTT. : Among individuals with positive POC test results, 97.6% (122/125) were also positive by the ELISA, and 85.6% (107/125) were positive by the TPHA. Additionally, 48.0% (60/125) and 42.4% (53/125) tested positive by the VDRL and RPR tests, respectively. Using the TPHA as a reference, TT tests showed sensitivities of 97-98% and specificities of 93-95% for detecting anti- antibodies using the ELISA and POC test, respectively. For the NTT, the VDRL test demonstrated a sensitivity of 98% and a specificity of 95% compared to the RPR test. The kappa coefficients were 0.85 for the POC test vs. the TPHA, 0.81 for the ELISA vs. the TPHA, and 0.89 for the VDRL vs. the RPR tests, indicating substantial agreement. : This study highlights a good diagnostic performance and high agreement levels among the evaluated serological tests for syphilis, reinforcing their utility in clinical and public health settings, as well as epidemiological studies.
梅毒在全球范围内仍然是一项重大的公共卫生挑战。准确且高效的诊断工具对于控制该疾病的传播至关重要。当前的诊断方法主要依赖血清学梅毒螺旋体检测（TTs）和非梅毒螺旋体检测（NTTs）。本研究的目的是评估各种血清学方法用于梅毒诊断的诊断特性。
样本于2020年3月至2023年5月期间从健康、信息和性传播感染监测（SIM研究）的参与者中收集，在巴西阿雷格里港的一个移动健康单元采用便利抽样。总共250名个体使用即时检验（POC）侧向流动梅毒螺旋体检测、性病研究实验室（VDRL）检测、快速血浆反应素（RPR）检测、酶联免疫吸附测定（ELISA）和血凝试验（TPHA）进行检测。其中，125名参与者在POC筛查中梅毒检测呈阳性。对POC检测、ELISA和VDRL检测的敏感性、特异性和预测值等诊断特性进行了评估。TPHA用作TT的参考标准，RPR检测用作NTT的参考标准。
在POC检测结果呈阳性的个体中，ELISA检测呈阳性的比例为97.6%（122/125），TPHA检测呈阳性的比例为85.6%（107/125）。此外，VDRL检测和RPR检测呈阳性的比例分别为48.0%（60/125）和42.4%（53/125）。以TPHA为参考，TT检测使用ELISA和POC检测检测抗抗体时的敏感性分别为97 - 98%，特异性分别为93 - 95%。对于NTT，与RPR检测相比，VDRL检测的敏感性为98%，特异性为95%。POC检测与TPHA的kappa系数为0.85，ELISA与TPHA的kappa系数为0.81，VDRL与RPR检测的kappa系数为0.89，表明一致性较高。
本研究突出了所评估的梅毒血清学检测具有良好的诊断性能和较高的一致性水平，强化了它们在临床、公共卫生环境以及流行病学研究中的效用。
