Withers Keenan, Bristow Clare, Nguyen Minh, Stafylis Chrysovalantis, Giang Le M, Klausner Jeffrey D
1 David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.
2 Division of Infectious Diseases and Global Public Health, Department of Medicine, University of California San Diego, La Jolla, CA, USA.
Int J STD AIDS. 2019 Feb;30(2):173-180. doi: 10.1177/0956462418802685. Epub 2018 Oct 23.
The SD BIOLINE HIV/Syphilis Duo (SD BIOLINE DUO) rapid test is a dual rapid lateral flow immunoassay that detects antibodies to both human immunodeficiency virus (HIV) and Treponema pallidum (TP) 'syphilis' via fingerprick whole blood. We evaluated the field performance of the SD BIOLINE HIV/Syphilis Duo test among two populations in Hanoi, Vietnam - men who have sex with men (MSM) and pregnant women. We also surveyed factors that influence participants' willingness to test for HIV and syphilis. This test has the potential to increase HIV and syphilis screening in low-resource settings. Patients who received healthcare services at a sexual health clinic for MSM and a district antenatal care center in Hanoi, Vietnam were recruited for the study. Participants with HIV and syphilis were intentionally recruited for adequate test performance evaluation via convenience sampling. At each facility, venipuncture blood specimens were obtained for reference testing for HIV and TP using SD BIOLINE HIV 1/2 3.0 and TP particle agglutination, respectively. SD BIOLINE DUO was compared to the standard reference tests and sensitivity and specificity were calculated. We calculated 95% confidence interval (CI) using the exact binomial method. We used conjoint analysis to identify test attributes that are associated with participant likelihood to seek HIV and syphilis testing. Of 280 participants, 100 (35.7%) were MSM and 180 (64.3%) were pregnant women. Of MSM, 17 (17.0%) were HIV positive and 49 (49.0%) were TP seropositive. All women were negative for both HIV and syphilis antibodies. For HIV antibody testing, sensitivity and specificity were 100.0% (95% CI: 80.5-100.0%) and 100.0% (95% CI: 98.6-100.0%), respectively. For the syphilis antibody testing, sensitivity and specificity were 83.1% (95% CI: 71.0-91.6%) and 100.0% (95% CI: 98.3-100.0%), respectively. Potential for false positives, preference for one blood draw over two, and shorter wait time for testing results were the highest ranked attributes by participants according to their willingness to test. The SD BIOLINE HIV/Syphilis Duo rapid test demonstrated very good performance in this field setting and participants preferred attributes that aligned well with this test.
SD生物线HIV/梅毒二联快速检测（SD BIOLINE DUO）是一种双快速侧向免疫分析方法，通过手指针刺全血检测人类免疫缺陷病毒（HIV）和梅毒螺旋体（TP）“梅毒”的抗体。我们评估了SD生物线HIV/梅毒二联检测在越南河内的两类人群——男男性行为者（MSM）和孕妇中的现场性能。我们还调查了影响参与者进行HIV和梅毒检测意愿的因素。该检测方法有潜力在资源匮乏地区增加HIV和梅毒筛查。在越南河内一家男男性行为者性健康诊所和一家地区产前护理中心接受医疗服务的患者被招募参加本研究。通过方便抽样有意招募了感染HIV和梅毒的参与者，以进行充分的检测性能评估。在每个机构，分别采集静脉穿刺血标本，使用SD生物线HIV 1/2 3.0和TP颗粒凝集试验进行HIV和TP的参考检测。将SD BIOLINE DUO与标准参考检测进行比较，并计算敏感性和特异性。我们使用精确二项式方法计算95%置信区间（CI）。我们使用联合分析来确定与参与者寻求HIV和梅毒检测可能性相关的检测属性。在280名参与者中，100名（35.7%）是男男性行为者；其余180名（64.3%）是孕妇。在男男性行为者中，17名（17.0%）HIV呈阳性，49名（49.0%）TP血清学呈阳性。所有女性的HIV和梅毒抗体均为阴性。对于HIV抗体检测，敏感性和特异性分别为100.0%（95%CI：80.5 - 100.0%）和100.0%（95%CI：98.6 - 100.0%）。对于梅毒抗体检测，敏感性和特异性分别为83.1%（95%CI：71.0 - 91.6%）和100.0%（95%CI：98.3 - 100.0%）。根据参与者的检测意愿，假阳性可能性、一次抽血优于两次抽血以及检测结果等待时间较短是排名最高的属性。SD生物线HIV/梅毒二联快速检测在该现场环境中表现出非常好的性能，参与者更喜欢与该检测方法相符的属性。
