背景:在全球范围内,通过使用经过验证的护理点测试(POCT)可以降低HIV和梅毒的发病率.作为世卫组织ProsPeRo网络的一部分,我们的目标是评估性能,可接受性,以及两种双重HIV/梅毒POCT(BiolineHIV/梅毒Duo(Abbott)和DPP®HIV-梅毒检测(Chembio)的操作特征,用于在男男性行为者(MSM)中筛查HIV和梅毒。
方法:对意大利2,577名MSM的横断面研究,马耳他,秘鲁,英国(UK)向七个诊所展示,已注册。收集手指刺血以进行POCT,并将结果与静脉穿刺血液的标准实验室研究进行比较。使用问卷评估可接受性和操作特征。诊断荟萃分析用于合并来自评估站点的数据。
结果:根据实验室测试,23.46%(n=598/2549)的参与者被确认为HIV阳性,35.88%的参与者(n=901/2511)在螺旋体参考测试中呈阳性.在所有显示出梅毒螺旋体抗体的参与者中,50.56%(n=455/900)为快速血浆Reagin(RPR)试验反应性。在艾滋病毒阳性个体中,60.62%(n=354/584)有梅毒螺旋体抗体的证据,其中60.45%(n=214/354)表现出反应性RPR测试,表明可能(共)感染。对于BiolinePOCT,合并对HIV的敏感性和特异性分别为98.95%和99.89%,梅毒分别为73.79%和99.57%。对于Chembio,对HIV的敏感性和特异性分别为98.66%和99.55%,梅毒分别为78.60%和99.48%。两种测试都可以检测到超过90%的可能的活动性梅毒病例,如反应性RPR和密螺旋体试验结果所定义。74.77%(n=1,926)的参与者首选这些双重POCT,由于他们的便利,和操作特点使它们被医疗保健提供者(HCP)接受。
结论:Bioline和Chembio双重POCT对梅毒和HIV均具有可接受的性能,ProSpeRo网络中MSM的可接受性和操作特性。这些双重POCT可以作为战略,更具成本效益,患者和医疗保健提供者(HCP)友好的替代常规测试;在临床和其他领域设置,尤其是那些资源有限的环境。
BACKGROUND: 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).
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.