Laboratoire de Virologie, CHU de Saint-Etienne, 42055 Saint-Etienne cedex 02, France.
J Clin Microbiol. 2011 Jan;49(1):292-7. doi: 10.1128/JCM.01688-10. Epub 2010 Nov 10.
The HIV-1 RNA viral load is commonly used for the monitoring of disease progression and antiretroviral treatment of HIV-1-infected patients. Since the misestimating of values could lead to inappropriate therapeutical management, the comparative performances, especially the ability to span the genetic diversity of HIV-1, of available automated real-time assays need to be evaluated. We conducted a prospective study with 74 consenting patients enrolled between March 2007 and November 2008. A blood sample was obtained at the time of diagnosis of HIV seropositivity and blindly tested for HIV-1 RNA by at least 4 commercial tests: the Abbott m2000 RealTime HIV-1, bioMérieux NucliSens EasyQ HIV-1, version 1.2 (v1.2), and Cobas AmpliPrep/Cobas TaqMan (CAP/CTM) v1.0 and v2.0 assays. The means of difference were null between CAP/CTM v2.0 and Abbott for CRF02_AG subtypes but positive in favor of CAP/CTM v2.0 for genotype B and negative in favor of NucliSens for all genotypes. The standard deviation (SD) of difference ranged from 0.3 to 0.59, depending on the considered couples of assays. Reliabilities of these four tests, appreciated by the standard deviation of difference between the measurement and the estimated "true" viral load and by the coefficient of reliability, were significantly different (P < 10(-4)) among each other. Significant differences were also observed within each group of HIV-1 genotype. The global disparity was higher for CRF02_AG than for B subtypes. This study indicates a risk of viral load misestimating or discrepancies between techniques, depending on the HIV-1 subtype, and speaks in favor of using the same assay for the monitoring of HIV-1-infected patients.
HIV-1 RNA 病毒载量通常用于监测疾病进展和接受抗逆转录病毒治疗的 HIV-1 感染者。由于错误估计值可能导致治疗管理不当,因此需要评估现有自动化实时检测方法的比较性能,特别是跨越 HIV-1 遗传多样性的能力。我们进行了一项前瞻性研究,共纳入 74 名自愿参与的患者,他们于 2007 年 3 月至 2008 年 11 月期间入组。在 HIV 血清学阳性确诊时采集血样,并用至少 4 种商业检测方法对 HIV-1 RNA 进行盲法检测:Abbott m2000 RealTime HIV-1、bioMérieux NucliSens EasyQ HIV-1 v1.2、Cobas AmpliPrep/Cobas TaqMan (CAP/CTM) v1.0 和 v2.0。CRF02_AG 亚型的 CAP/CTM v2.0 和 Abbott 之间的差值平均值为零,但有利于 CAP/CTM v2.0 的结果;而对于基因型 B,差值平均值为正,有利于 CAP/CTM v2.0;对于所有基因型,差值平均值为负,有利于 NucliSens。差异的标准差(SD)范围为 0.3 至 0.59,取决于考虑的检测方法对。通过差值的标准差(即测量值与估计的“真实”病毒载量之间的差异)和可靠性系数来评估这四种检测方法的可靠性,它们彼此之间存在显著差异(P < 0.001)。在每个 HIV-1 基因型组内也观察到显著差异。CRF02_AG 亚型的全球差异高于 B 亚型。这项研究表明,HIV-1 亚型不同时,存在病毒载量估计错误或不同技术之间的差异的风险,因此主张对 HIV-1 感染者进行监测时使用相同的检测方法。