Division of STD Prevention, Centers for Disease Control and Prevention, Atlanta, GA, 30329, USA.
Division of Global HIV &TB, Centers for Disease Control and Prevention, Atlanta, GA, USA.
BMC Infect Dis. 2024 Feb 29;24(Suppl 1):194. doi: 10.1186/s12879-024-09027-3.
Sexually transmitted infections (STIs) such as syphilis and HIV remain to be a significant public health issue worldwide. Dual rapid point-of-care tests (POCTs) have shown promise for detecting antibodies to HIV and syphilis but have not been fully evaluated in the field. Our study supported the WHO ProSPeRo study on Sexually Transmitted Infection Point-of-Care Testing (STI POCT) by providing external quality assessment (EQA) for HIV and syphilis testing in reference laboratories and their associated clinical sites in seven countries.
HIV/syphilis serum liquid and dried tube specimen (DTS) panels were prepared by CDC. Liquid panels were distributed to the reference laboratories for three rounds of testing using commercially and locally available laboratory-based serological tests. DTS panels were sent to the clinical testing sites for 8 rounds of POC testing using the Abbott SD BIOLINE HIV/Syphilis Duo test (hereafter referred to as SD BIOLINE) and the Chembio Dual Path Platform (DPP) HIV-Syphilis assay. EQA panels were tested at CDC using the Rapid Plasma Reagin (RPR) test and the Treponema pallidum Particle Agglutination assay (TP-PA) for syphilis antibodies. Genetic Systems HIV-1/HIV-2 Plus O EIA, Geenius HIV Supplemental Assay and the Oraquick Advance HIV test were used to detect HIV antibodies in the EQA panels. Results from the reference laboratories and POCT sites were compared to those obtained at the CDC and a percentage agreement was calculated.
Qualitative RPR and TP-PA performed at the reference laboratories demonstrated 95.4-100% agreement with CDC results while quantitative RPR and TP-PA tests demonstrated 87.7% and 89.2% agreement, respectively. A 93.8% concordance rate was observed for qualitative HIV testing in laboratories. EQA testing at clinical sites using dual tests showed 98.7% and 99.1% agreement for detection of HIV antibodies and eight out of 10 sites had > 95.8% agreement for syphilis testing. However, two clinical sites showed only 65.0-66.7% agreement for SD BIOLINE and 84.0-86.7% for DPP, respectively, for syphilis testing.
Overall, laboratories demonstrated high EQA performance in this study. Both HIV/syphilis POCTs gave expected results in the clinic-based evaluations using DTS. However, testing errors were identified in a few testing sites suggesting the necessity for continuous training and monitoring the quality of POC testing.
性传播感染（STIs），如梅毒和艾滋病毒，仍然是全球一个重大的公共卫生问题。双重快速即时检测（POCT）已显示出在检测艾滋病毒和梅毒抗体方面的应用前景，但尚未在现场得到充分评估。我们的研究通过为七个国家的参考实验室及其相关临床检测点提供艾滋病毒和梅毒检测的外部质量评估（EQA），支持了世卫组织关于性传播感染即时检测（STI POCT）的 ProSPeRo 研究。
美国疾病控制与预防中心（CDC）制备了艾滋病毒/梅毒血清液和干管标本（DTS）检测板。将液体检测板分发给参考实验室，使用市售和当地可用的实验室基于血清学的检测方法进行了三轮检测。DTS 检测板被送往临床检测点，使用 Abbott SD BIOLINE HIV/梅毒双联检测试剂盒（简称 SD BIOLINE）和 Chembio 双通道平台（DPP）艾滋病毒-梅毒检测试剂盒进行了八轮 POCT 检测。EQA 检测板在 CDC 用快速血浆反应素（RPR）试验和梅毒螺旋体颗粒凝集试验（TP-PA）检测梅毒抗体。用于检测 EQA 检测板中艾滋病毒抗体的方法包括 Genetic Systems HIV-1/HIV-2 Plus O EIA、Geenius HIV 补充检测和 Oraquick 艾滋病快速检测试剂盒。
参考实验室的定性 RPR 和 TP-PA 与 CDC 结果的符合率为 95.4-100%，而定量 RPR 和 TP-PA 试验的符合率分别为 87.7%和 89.2%。实验室定性 HIV 检测的符合率为 93.8%。使用双重检测在临床检测点进行 EQA 检测，艾滋病毒抗体的符合率为 98.7%和 99.1%，10 个检测点中有 8 个的梅毒检测符合率大于 95.8%。然而，有两个临床检测点的 SD BIOLINE 和 DPP 梅毒检测的符合率分别为 65.0-66.7%和 84.0-86.7%。
总体而言，实验室在本研究中表现出了较高的 EQA 性能。两种 HIV/梅毒 POCT 在基于 DTS 的临床评估中均得到了预期的结果。然而，在一些检测点发现了检测错误，这表明需要持续培训和监测 POCT 的质量。
