Adams Sarah, Luo Wei, Wesolowski Laura, Cohen Stephanie E, Peters Philip J, Owen S Michele, Masciotra Silvina
Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States.
San Francisco Department of Public Health, San Francisco, CA, United States.
J Clin Virol. 2017 Jun;91:90-94. doi: 10.1016/j.jcv.2017.03.012. Epub 2017 Mar 23.
The flow-through INSTI™ HIV-1/HIV-2 Rapid Antibody (INSTI) test is a 60s FDA-approved test for HIV-1 and HIV-2 antibody testing using whole blood and plasma.
We evaluated the performance of INSTI using plasma and simulated whole blood specimens.
INSTI's performance in plasma specimens from commercial seroconversion panels was assessed by estimating the relative sensitivity using a 50% cumulative frequency analysis and by comparing its performance with other FDA-approved rapid tests (RTs). INSTI was further evaluated using 320 HIV-1 plasma specimens collected during a cross-sectional study and with 107 HIV-1 and 24 HIV-2 simulated whole blood specimens. Sensitivity and specificity were calculated using 615 known HIV-1 group M/O and 80 HIV-2 (Western blot (WB)-positive), and 497 HIV-negative plasma specimens, respectively.
In HIV-1 seroconversion panels, INSTI became reactive 9days before a positive WB. When compared to FDA-approved antibody-based lateral flow RTs, INSTI detected significantly more early infections. Among HIV-1-infected cross-sectional plasma samples, INSTI detected 23 (27%) of 85 Architect-positive/Multispot-negative or indeterminate specimens. For plasma specimens, the sensitivity was 99.84% for HIV-1 and 100% for HIV-2, and the specificity was 99.80%. Using simulated whole blood from seroconverters, INSTI performed similarly to plasma.
INSTI performed significantly better than antibody-based lateral flow RTs during early stages of seroconversion. Sensitivity and specificity were within the manufacturer's reported ranges. Considering the observed test performance and the almost immediate results, INSTI is an accurate option to detect HIV-1/HIV-2 antibodies in point-of-care settings where lab testing is not feasible.
流通式整合酶链免疫分析（INSTI™）HIV-1/HIV-2快速抗体检测是一种经美国食品药品监督管理局（FDA）批准的60秒检测方法，用于使用全血和血浆进行HIV-1和HIV-2抗体检测。
我们使用血浆和模拟全血标本评估了INSTI的性能。
通过使用50%累积频率分析估计相对敏感性，并将其性能与其他FDA批准的快速检测（RT）进行比较，评估了INSTI在商业血清转换检测板血浆标本中的性能。使用在一项横断面研究中收集的320份HIV-1血浆标本以及107份HIV-1和24份HIV-2模拟全血标本对INSTI进行了进一步评估。分别使用615份已知的HIV-1 M/O组和80份HIV-2（免疫印迹法（WB）阳性）以及497份HIV阴性血浆标本计算敏感性和特异性。
在HIV-1血清转换检测板中，INSTI在WB呈阳性前9天就呈反应性。与FDA批准的基于抗体的侧向流动RT相比，INSTI检测到的早期感染明显更多。在HIV-1感染的横断面血浆样本中，INSTI在85份Architect阳性/多斑点阴性或不确定标本中检测到23份（27%）。对于血浆标本，HIV-1的敏感性为99.84%，HIV-2的敏感性为100%，特异性为99.80%。使用血清转换者的模拟全血，INSTI的表现与血浆相似。
在血清转换的早期阶段，INSTI的表现明显优于基于抗体的侧向流动RT。敏感性和特异性在制造商报告的范围内。考虑到观察到的检测性能和几乎即时的结果，在无法进行实验室检测的即时护理环境中，INSTI是检测HIV-1/HIV-2抗体的准确选择。
