Laboratório de Biologia Molecular, Serviço de Medicina Transfusional, Centro Hospitalar Lisboa Ocidental, Hospital Egas Moniz, Lisboa, Portugal.
J Virol Methods. 2013 Oct;193(1):18-22. doi: 10.1016/j.jviromet.2013.05.001. Epub 2013 May 18.
Quantitation of HIV-1 RNA levels in plasma has significant prognostic value since high viral load concentrations in plasma are associated with a faster disease progression. Viral load testing became one the most important tools for monitoring HIV patients. New real time methodologies to quantify HIV viral load had arisen in the last decade. HIV is a virus with a high genetic variability, with the potential to negatively affect the performance of the viral load assays. Consequently, any new assay should be challenged against, at least, the most prevalent HIV-1 genetic variants. In the present study, the new version of NucliSENS EasyQ(®) HIV-1 (Version 2.0) quantitative assay was compared with another ultra-sensitive test--Abbott RealTime HIV-1--using 175 plasma samples from patients infected with several HIV-1 subtypes and recombinant forms: subtype B (41, 23%), subtype C (19, 11%), subtype G (76, 44%), and CRF02_AG (39, 22%). Overall, there was agreement between the assays in 95.43% of the samples. Both assays have a very good dynamic range [1.4-6.9] and [1.60-7.0] log10 copies/mL and excellent correlation in samples with various subtypes. Based on the fact that no clinically significant differences were observed in the viral load measurements by these two assays, HIV-1 subtypes are quantified equally by both assays. However due to HIV diversity, mainly in regions were non B subtypes are predominant more evaluations are needed, so we do not recommend to switch platform during longitudinal viral load monitoring.
血浆中 HIV-1 RNA 水平的定量具有重要的预后价值，因为血浆中高病毒载量浓度与疾病进展更快相关。病毒载量检测已成为监测 HIV 患者的最重要工具之一。在过去十年中，出现了新的实时方法来定量 HIV 病毒载量。HIV 是一种具有高度遗传变异性的病毒，有可能对病毒载量检测的性能产生负面影响。因此，任何新的检测方法都应该至少与最常见的 HIV-1 遗传变异体进行比较。在本研究中，使用来自感染多种 HIV-1 亚型和重组形式的 175 份血浆样本，比较了新的 NucliSENS EasyQ(®) HIV-1 (Version 2.0) 定量检测与另一种超灵敏检测——Abbott RealTime HIV-1。这些亚型和重组形式包括：亚型 B（41，23%）、亚型 C（19，11%）、亚型 G（76，44%）和 CRF02_AG（39，22%）。总体而言，两种检测方法在 95.43%的样本中具有一致性。两种检测方法的动态范围都非常好[1.4-6.9]和[1.60-7.0] log10 拷贝/mL，在各种亚型的样本中具有极好的相关性。由于这两种检测方法在病毒载量测量方面没有观察到临床意义上的显著差异，因此两种检测方法对 HIV-1 亚型的定量结果相同。然而，由于 HIV 的多样性，特别是在非 B 亚型占主导地位的地区，需要进行更多的评估，因此我们不建议在纵向病毒载量监测期间切换平台。
