National HIV Reference Laboratory, Central Virology Laboratory, Ministry of Health, Tel-Hashomer, Ramat-Gan, Israel.
Israel Center for Disease Control, Ministry of Health, Tel-Hashomer, Ramat-Gan, Israel.
J Clin Virol. 2018 Apr;101:7-10. doi: 10.1016/j.jcv.2018.01.007. Epub 2018 Jan 17.
Architect (AR) and Vidas (VD) fourth generation HIV screening immunoassays, which identify early stages of HIV infections, could have false positive results especially at low signal/cutoff (S/C) AR values. Geenius HIV1/2 (GS) is a specific confirmation line immunoassay that is not highly sensitive to early HIV infections. An HIV-1 RNA assay may better detect such infections.
To evaluate all AR-VD reactive samples with GS results, and to assess Xpert Qual HIV-1 RNA assay (XQ) as an alternative to GS, in the first low S/C AR-VD-reactive samples from a tested individual.
First AR-VD-reactive-GS-tested results from all individuals with resolved HIV status, collected between March 2015 and March 2017 (n = 749), were retrospectively assessed. Samples with AR-VD-reactive-GS-discordant results and those with low S/C AR-VD-reactive results, were tested by XQ. Receiver operating characteristic (ROC) analysis of GS and XQ sensitivity/specificity was performed.
Overall, 94.1% (705/749) of AR-VD-reactive results were true HIV-1 positive. All samples with <3 S/C AR values were false positive. XQ resolved all first samples with AR-VD-reactive-GS-discordant results. The diagnostic accuracy of XQ in low (≤33 S/C) AR-VD-reactive samples was better than that of GS (97.6%, 81/83 versus 73.5%, 61/83, p < 0.01). ROC analysis for low S/C AR samples was optimal for pooled XQ and GS results.
Incorporating XQ in the current screening algorithm for the first AR-VD-reactive-GS-discordant samples may significantly reduce overall turn-around time of HIV-1 diagnosis.
Architect（AR）和 Vidas（VD）第四代 HIV 筛查免疫测定法可识别 HIV 感染的早期阶段，尤其是在低信号/截止值（S/C）AR 值时，可能会出现假阳性结果。Geenius HIV1/2（GS）是一种特异性确证线免疫测定法，对早期 HIV 感染不高度敏感。HIV-1 RNA 测定法可能更好地检测此类感染。
评估所有 AR-VD 反应性样本的 GS 结果，并评估 Xpert Qual HIV-1 RNA 测定法（XQ）作为 GS 的替代方法，用于检测个体的第一个低 S/C AR-VD 反应性样本。
回顾性评估了 2015 年 3 月至 2017 年 3 月期间所有已确定 HIV 状态个体的第一个 AR-VD 反应性-GS 检测结果（n=749）。对 AR-VD 反应性-GS 不一致的样本和低 S/C AR-VD 反应性的样本进行 XQ 检测。对 GS 和 XQ 的灵敏度/特异性进行了受试者工作特征（ROC）分析。
总体而言，94.1%（705/749）的 AR-VD 反应性结果为 HIV-1 阳性。所有 S/C AR 值<3 的样本均为假阳性。XQ 解决了所有 AR-VD 反应性-GS 不一致的第一份样本。在低（≤33 S/C）AR-VD 反应性样本中，XQ 的诊断准确性优于 GS（97.6%，81/83 与 73.5%，61/83，p<0.01）。ROC 分析表明，低 S/C AR 样本的 XQ 和 GS 结果具有最佳的综合效果。
在当前的 AR-VD 反应性-GS 不一致的第一份样本的筛查算法中加入 XQ 可能会显著缩短 HIV-1 诊断的整体周转时间。
