U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA
U.S. Military HIV Research Program, Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, Maryland, USA.
J Clin Microbiol. 2019 Apr 26;57(5). doi: 10.1128/JCM.01922-18. Print 2019 May.
The Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 test, v2.0 (the CAP/CTM assay), was used to quantify cell-associated HIV-1 (CAH) nucleic acid in peripheral blood mononuclear cells (PBMC) from well-characterized clinical specimens from HIV-1-infected individuals on antiretroviral therapy (ART). Chronically infected individuals on ART with no detectable plasma HIV-1 RNA demonstrated average CAH burdens of 3.2 HIV-1 log copies/million cells. Assay sensitivity and specificity were 98.9% and 100%, respectively, with the positive and negative predictive values being 100% and 98.6%, respectively. The CAH burden was also measured at weeks 0, 1, 2, 8, and 60 in 37 participants (RV254/SEARCH010, Bangkok, Thailand) stratified by Fiebig stage (Fiebig stage I [FI] to FVI) at ART initiation. Prior to ART initiation, the average CAH burden was 1.4, 4.1, and 3.6 log copies/million PBMCs for individuals who initiated ART at FI, FII, and FIII to FVI, respectively. Initiation of ART resulted in a rapid decline of CAH in all individuals, with the greatest decrease being observed in individuals who initiated ART at FI to FIII. By week 60, 100% (FI), 71.8% (FII/FIII), and 20.5% (FIV to FVI) of samples from individuals initiating treatment were at or near the limit of quantitation. Residual CAH was detectable at 60 weeks in most individuals who initiated ART at later stages (FIV to FVI) and averaged 1.9 ± 0.7 log copies/million PBMCs. The modified Roche CAP/CTM assay provides a convenient, standardized approach to measure residual HIV in blood and may be useful for monitoring patients under therapy or those participating in HIV remission studies.
罗氏 Cobas AmpliPrep/Cobas TaqMan HIV-1 检测试剂盒（v2.0，即 CAP/CTM 检测）用于定量分析接受抗反转录病毒治疗（ART）的 HIV-1 感染者外周血单个核细胞（PBMC）中细胞相关 HIV-1（CAH）核酸。在接受 ART 的慢性 HIV-1 感染者中，未检测到血浆 HIV-1 RNA 的个体，其平均 CAH 负荷为 3.2 HIV-1 log 拷贝/百万细胞。该检测的灵敏度和特异性分别为 98.9%和 100%，阳性和阴性预测值分别为 100%和 98.6%。在来自接受 ART 的 HIV-1 感染者的 37 份临床标本中（RV254/SEARCH010，泰国曼谷），根据治疗开始时的 Fiebig 分期（FI 至 FVI）进行分层，在 0、1、2、8 和 60 周时测量 CAH 负荷。在开始 ART 前，分别在 FI、FII 和 FIII 至 FVI 开始 ART 的个体中，CAH 负荷平均值为 1.4、4.1 和 3.6 log 拷贝/百万 PBMC。在所有个体中，开始 ART 后 CAH 迅速下降，在 FI 至 FIII 开始 ART 的个体中观察到最大降幅。在 60 周时，100%（FI）、71.8%（FII/FIII）和 20.5%（FIV 至 FVI）的个体治疗开始时的样本达到或接近定量检测限。大多数在晚期（FIV 至 FVI）开始 ART 的个体在 60 周时仍可检测到残留 CAH，平均为 1.9±0.7 log 拷贝/百万 PBMC。改良罗氏 CAP/CTM 检测提供了一种方便、标准化的方法来测量血液中的残留 HIV，可能有助于监测接受治疗的患者或参与 HIV 缓解研究的患者。
