Department of Clinical Microbiology 445, Hvidovre Hospital, Kettegård Alle 30, DK-2650 Hvidovre, Denmark; Department for Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.
Department of Clinical Microbiology 445, Hvidovre Hospital, Kettegård Alle 30, DK-2650 Hvidovre, Denmark.
J Clin Virol. 2017 Jul;92:14-19. doi: 10.1016/j.jcv.2017.05.006. Epub 2017 May 8.
HIV-RNA is the most important parameter for monitoring antiviral treatment in individuals infected with HIV-1. Knowledge of the performance of different tests for the quantification of HIV-1 RNA is therefore important for clinical care.
To compare the analytical performance of the Aptima HIV-1 Quant Dx Assay (Aptima) and the COBAS Ampliprep/COBAS TaqMan HIV-1 Test v2.0 (CAPCTMv2) for the quantification of HIV-1 RNA in plasma samples.
The performance of the two tests was compared on 216 clinical plasma samples, on dilutions series in seven replicates of five clinical samples of known subtype and on ten replicates of the Acrometrix High and Low Positive Control.
Bland-Altman analysis of 130 samples that quantified in both tests did not show indications of gross mis-quantification of either test. A tendency of the Aptima assay to quantify higher at high viral load compared to the CAPCTMv2 was observed in Bland-Altman analysis, by Deming regression (Slope 1.13) and in dilution series of clinical samples. Precision evaluated using the Acrometrix Positive Controls was similar for the High Control (CV: 1.2% vs. 1.3%; Aptima assay vs. CAPCTMv2 test, respectively), but differed for the Low control (CV: 17.9% vs. 7.1%; Aptima assay vs. CAPCTMv2 test, respectively). However, this did not impact clinical categorization of clinical samples at neither the 50 cp/mL nor 200 cp/mL level.
The Aptima assay and the CAPCTMv2 test are highly correlated and are useful for monitoring HIV-infected individuals.
HIV-RNA 是监测感染 HIV-1 个体抗病毒治疗的最重要参数。因此，了解不同 HIV-1 RNA 定量检测方法的性能对于临床护理非常重要。
比较 Aptima HIV-1 Quant Dx 检测（Aptima）和 COBAS Ampliprep/COBAS TaqMan HIV-1 测试 v2.0（CAPCTMv2）在血浆样本中定量检测 HIV-1 RNA 的分析性能。
对 216 份临床血浆样本、5 份已知亚型临床样本的 7 个重复稀释系列和 10 个 Acrometrix 高值和低值阳性对照的 10 个重复进行了两种检测方法的性能比较。
在两种检测方法均能定量的 130 份样本的 Bland-Altman 分析中，没有迹象表明两种检测方法均存在明显的定量错误。Bland-Altman 分析、Deming 回归（斜率 1.13）和临床样本稀释系列均显示，与 CAPCTMv2 相比，Aptima 检测法在高病毒载量时定量偏高。使用 Acrometrix 阳性对照评估的精密度在高值对照（CV：1.2%比 1.3%；Aptima 检测法与 CAPCTMv2 检测法）相似，但在低值对照（CV：17.9%比 7.1%；Aptima 检测法与 CAPCTMv2 检测法）有所不同。然而，这并未影响到 50 cp/mL 和 200 cp/mL 水平的临床样本的临床分类。
Aptima 检测法和 CAPCTMv2 检测法高度相关，可用于监测感染 HIV 的个体。
