Data from: Sensitivity and specificity of point-of-care rapid combination syphilis-HIV-HCV tests

Background: New rapid point-of-care (POC) tests are being developed that would offer the opportunity to increase screening and treatment of several infections, including syphilis. This study evaluated three of these new rapid POC tests at a site in Southern California. Methods: Participants were recruited from a testing center in Long Beach, California. A whole blood specimen was used to evaluate the performance of the Dual Path Platform (DPP) Syphilis Screen & Confirm, DPP HIV-Syphilis, and DPP HIV-HCV-Syphilis rapid tests. The gold-standard comparisons were Treponema pallidum passive particle agglutination (TPPA), rapid plasma reagin (RPR), HCV enzyme immunoassay (EIA), and HIV-1/2 EIA. Results: A total of 948 whole blood specimens were analyzed in this study. The sensitivity of the HIV tests ranged from 95.7–100% and the specificity was 99.7–100%. The sensitivity and specificity of the HCV test were 91.8% and 99.3%, respectively. The treponemal-test sensitivity when compared to TPPA ranged from 44.0–52.7% and specificity was 98.7–99.6%. The non-treponemal test sensitivity and specificity when compared to RPR was 47.8% and 98.9%, respectively. The sensitivity of the Screen & Confirm test improved to 90.0% when cases who were both treponemal and nontreponemal positive were compared to TPPA+/RPR ≥1:8. Conclusions: The HIV and HCV on the multi-infection tests showed good performance, but the treponemal and nontreponemal tests had low sensitivity. These results could be due to a low prevalence of active syphilis in the sample population because the sensitivity improved when the gold standard was limited to those more likely to be active cases. Further evaluation of the new syphilis POC tests is required before implementation into testing programs.

背景：目前正在开发新型快速即时检测（Point-of-Care, POC）技术，有望提升包括梅毒在内的多种感染性疾病的筛查与治疗水平。本研究于美国加利福尼亚州南部的一处检测站点，对三款此类新型快速POC检测试剂开展了性能评估。
方法：研究受试者招募自美国加利福尼亚州长滩市的一处检测中心。本研究采用全血标本，对三款快速检测试剂的性能进行评估，分别为双路径平台（Dual Path Platform, DPP）梅毒筛查确证试剂、DPP HIV-梅毒联合检测试剂，以及DPP HIV-丙肝病毒（HCV）-梅毒联合检测试剂。本研究以梅毒螺旋体被动颗粒凝集试验（Treponema pallidum passive particle agglutination, TPPA）、快速血浆反应素试验（rapid plasma reagin, RPR）、HCV酶联免疫吸附试验（enzyme immunoassay, EIA）以及HIV-1/2型酶联免疫吸附试验作为金标准对照方法。
结果：本研究共纳入948份全血标本进行分析。HIV检测的灵敏度区间为95.7%~100%，特异度区间为99.7%~100%。HCV检测的灵敏度与特异度分别为91.8%和99.3%。以TPPA为金标准时，梅毒螺旋体检测的灵敏度区间为44.0%~52.7%，特异度区间为98.7%~99.6%；以RPR为金标准时，非梅毒螺旋体检测的灵敏度与特异度分别为47.8%和98.9%。当仅针对梅毒螺旋体检测与非梅毒螺旋体检测均呈阳性的病例，以TPPA阳性且RPR滴度≥1:8作为金标准时，梅毒筛查确证试剂的灵敏度提升至90.0%。
结论：联合检测试剂中的HIV与HCV检测模块表现良好，但梅毒螺旋体及非梅毒螺旋体检测模块的灵敏度偏低。本研究结果或与受试人群中活动性梅毒的患病率较低相关，因为当仅将金标准限定于更可能为活动性梅毒病例的人群时，检测灵敏度有所提升。此类新型梅毒POC检测试剂在应用于临床检测项目前，仍需开展进一步的性能评估。