Rossetti Rebecca, Smith Tara, Luo Wei, Masciotra Silvina
Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, United States.
Oak Ridge Institute for Science and Education, United States.
J Clin Virol. 2020 Jun;127:104344. doi: 10.1016/j.jcv.2020.104344. Epub 2020 Apr 11.
The Reveal G4 antibody rapid test is FDA-approved for HIV-1 detection using the versions LAB S/P and POC in CLIA-moderate complexity settings with serum/plasma and whole blood, respectively. The same Reveal tests are CE-marked for HIV-1 and HIV-2 detection in laboratory and point-of-care (POC) settings.
We compared the performance of G4 LAB S/P with plasma and POC with whole blood (blood) for detecting early and established HIV-1/HIV-2 infections.
Matched well-characterized plasma and simulated blood were used to evaluate: sensitivity in 104 HIV-1 and 55 HIV-2 established infections, specificity in 49 HIV-negative, and reactivity in early HIV-1 infection in a performance panel (n=38) and 18 plasma panels from seroconverters (SCs, n=183). Median number of days after first RNA-positive was calculated for 13 SCs. Impact of viral suppression (VS) was evaluated in 3 SCs receiving early antiretroviral therapy (ART).
Sensitivity was 100 % for HIV-1 and 98.18 % for HIV-2, while specificity was 100 %. All 38 plasma and blood become reactive by Fiebig stage V. Of 18 SCs, 10 had similar reactivity in plasma/blood, 7 showed delayed reactivity in blood, and 1 was nonreactive in plasma/blood. The median days for a G4-reactive after first RNApositive was 13 for plasma and 14 for blood. Long-term VS had no impact on G4 reactivity.
Overall reactivity in early HIV-1 infections is delayed by one day in blood compared to plasma. If FDA-approved for POC settings, the G4 POC is a fast sensitive screening tool for HIV-1/HIV-2-specific IgG even during VS.
Reveal G4抗体快速检测经美国食品药品监督管理局（FDA）批准，可分别在CLIA中等复杂程度的环境中使用LAB S/P版本检测血清/血浆中的HIV-1，以及使用POC版本检测全血中的HIV-1。同样的Reveal检测在实验室和即时检验（POC）环境中获得CE标志，用于检测HIV-1和HIV-2。
我们比较了G4 LAB S/P检测血浆和G4 POC检测全血在检测早期和已确诊的HIV-1/HIV-2感染方面的性能。
使用匹配良好且特征明确的血浆和模拟血液来评估：在104例HIV-1确诊感染和55例HIV-2确诊感染中的敏感性、在49例HIV阴性中的特异性，以及在一个性能评估组（n = 38）和18个来自血清转化者（SCs，n = 183）的血浆评估组中对早期HIV-1感染的反应性。计算了13例SCs首次RNA阳性后的中位天数。在3例接受早期抗逆转录病毒治疗（ART）的SCs中评估了病毒抑制（VS）的影响。
HIV-1的敏感性为100%，HIV-2的敏感性为98.18%，而特异性为100%。所有38份血浆和全血在Fiebig V期均呈反应性。在18例SCs中，10例在血浆/全血中具有相似的反应性，7例在全血中反应延迟，1例在血浆/全血中无反应。首次RNA阳性后G4呈反应性的中位天数，血浆为13天，全血为14天。长期VS对G4反应性无影响。
与血浆相比，全血中早期HIV-1感染的总体反应性延迟一天。如果经FDA批准用于POC环境，G4 POC即使在VS期间也是一种快速灵敏的HIV-1/HIV-2特异性IgG筛查工具。
