School of Sport and Health Sciences, University of Brighton, Village Way, Falmer, BN1 9PH, UK.
Centre for Transforming Sexuality and Gender, University of Brighton, Edward Street, Brighton, BN2 0JG, UK.
BMC Infect Dis. 2024 Feb 29;24(Suppl 1):192. doi: 10.1186/s12879-024-09019-3.
Globally, the incidence of HIV and syphilis can be reduced by the use of validated point of care tests (POCTs). As part of the WHO PRoSPeRo Network, we aimed to evaluate the performance, acceptability, and operational characteristics of two dual HIV/syphilis POCTs (Bioline HIV/Syphilis Duo (Abbott) and DPP® HIV-Syphilis assay (Chembio) for the screening of HIV and syphilis amongst men who have sex with men (MSM).
A cross sectional study of 2,577 MSM in Italy, Malta, Peru, and the United Kingdom (UK) presenting to seven clinic sites, were enrolled. Finger prick blood was collected to perform POCTs and results compared with standard laboratory investigations on venepuncture blood. Acceptability and operational characteristics were assessed using questionnaires. Diagnostic meta-analysis was used to combine data from the evaluation sites.
Based on laboratory tests, 23.46% (n = 598/2549) of participants were confirmed HIV positive, and 35.88% of participants (n = 901/2511) were positive on treponemal reference testing. Of all participants showing evidence of antibodies to Treponema pallidum, 50.56% (n = 455/900) were Rapid Plasma Reagin (RPR) test reactive. Of HIV positive individuals, 60.62% (n = 354/584) had evidence of antibodies to T. pallidum, and of these 60.45% (n = 214/354) exhibited reactive RPR tests indicating probable (co)infection. For Bioline POCT, pooled sensitivities and specificities for HIV were 98.95% and 99.89% respectively, and for syphilis were 73.79% and 99.57%. For Chembio pooled sensitivities and specificities for HIV were 98.66% and 99.55%, and for syphilis were 78.60% and 99.48%. Both tests can detect greater than 90% of probable active syphilis cases, as defined by reactive RPR and treponemal test results. These dual POCTs were preferred by 74.77% (n = 1,926) of participants, due to their convenience, and the operational characteristics made them acceptable to health care providers (HCPs).
Both the Bioline and the Chembio dual POCT for syphilis and HIV had acceptable performance, acceptability and operational characteristics amongst MSM in the PRoSPeRo network. These dual POCTs could serve as a strategic, more cost effective, patient and healthcare provider (HCP) friendly alternative to conventional testing; in clinical and other field settings, especially those in resource-limited settings.
在全球范围内，使用经过验证的即时检测（POCT）可以降低艾滋病毒和梅毒的发病率。作为世界卫生组织 PRoSPeRo 网络的一部分，我们旨在评估两种双重 HIV/梅毒 POCT（Bioline HIV/Syphilis Duo（雅培）和 DPP®HIV-Syphilis 检测（Chembio）在男男性行为者（MSM）中筛查 HIV 和梅毒的性能、可接受性和操作特性。
在意大利、马耳他、秘鲁和英国（UK）的七个诊所招募了 2577 名 MSM 进行横断面研究。采集指刺血进行 POCT，并将结果与静脉血的标准实验室检查进行比较。使用问卷评估可接受性和操作特性。使用诊断荟萃分析合并评估点的数据。
根据实验室检测，23.46%（n=598/2549）的参与者被确认为 HIV 阳性，35.88%（n=901/2511）的参与者对梅毒螺旋体参考检测呈阳性。在所有显示梅毒密螺旋体抗体证据的参与者中，50.56%（n=455/900）的快速血浆反应素（RPR）试验呈阳性。在 HIV 阳性个体中，60.62%（n=354/584）有梅毒密螺旋体抗体证据，其中 60.45%（n=214/354）的 RPR 试验呈阳性，表明可能（合并）感染。对于 Bioline POCT，HIV 的汇总敏感性和特异性分别为 98.95%和 99.89%，梅毒为 73.79%和 99.57%。对于 Chembio，HIV 的汇总敏感性和特异性分别为 98.66%和 99.55%，梅毒为 78.60%和 99.48%。这两种检测都可以检测到超过 90%的可能活动性梅毒病例，这是根据 RPR 和梅毒螺旋体检测结果确定的。由于其便利性，这两种双重 POCT 都受到 74.77%（n=1926）的参与者的青睐，并且它们的操作特性也使医疗保健提供者（HCP）能够接受。
Bioline 和 Chembio 双重 POCT 用于梅毒和 HIV 在 PRoSPeRo 网络中的 MSM 中具有可接受的性能、可接受性和操作特性。这些双重 POCT 可作为一种具有战略意义、更具成本效益、更受患者和医疗保健提供者（HCP）欢迎的替代常规检测的方法；特别是在资源有限的环境中，在临床和其他实地环境中。
