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首页> 外文期刊>Journal of Clinical Microbiology >Evaluation of the RealTime HIV-1, Xpert HIV-1, and Aptima HIV-1 Quant Dx Assays in Comparison to the NucliSens EasyQ HIV-1 v2.0 Assay for Quantification of HIV-1 Viral Load
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Evaluation of the RealTime HIV-1, Xpert HIV-1, and Aptima HIV-1 Quant Dx Assays in Comparison to the NucliSens EasyQ HIV-1 v2.0 Assay for Quantification of HIV-1 Viral Load

机译：评估实时HIV-1，Xpert HIV-1和Aptima HIV-1 Quant Dx分析与NucliSens EasyQ HIV-1 v2.0定量分析HIV-1病毒载量的比较

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HIV-1 RNA monitoring, both before and during antiretroviral therapy, is an integral part of HIV management worldwide. Measurements of HIV-1 viral loads are expected to assess the copy numbers of all common HIV-1 subtypes accurately and to be equally sensitive at different viral loads. In this study, we compared for the first time the performance of the NucliSens v2.0, RealTime HIV-1, Aptima HIV-1 Quant Dx, and Xpert HIV-1 viral load assays. Plasma samples (n = 404) were selected on the basis of their NucliSens v2.0 viral load results and HIV-1 subtypes. Concordance, linear regression, and Bland-Altman plots were assessed, and mixed-model analysis was utilized to compare the analytical performance of the assays for different HIV-1 subtypes and for low and high HIV-1 copy numbers. Overall, high concordance (>83.89%), high correlation values (Pearson r values of >0.89), and good agreement were observed among all assays, although the Xpert and Aptima assays, which provided the most similar outputs (estimated mean viral loads of 2.67 log copies/ml [95% confidence interval [CI], 2.50 to 2.84 log copies/ml] and 2.68 log copies/ml [95% CI, 2.49 to 2.86 log copies/ml], respectively), correlated best with the RealTime assay (89.8% concordance, with Pearson r values of 0.97 to 0.98). These three assays exhibited greater precision than the NucliSens v2.0 assay. All assays were equally sensitive for subtype B and AG/G samples and for samples with viral loads of 1.60 to 3.00 log copies/ml. The NucliSens v2.0 assay underestimated A1 samples and those with viral loads of >3.00 log copies/ml. The RealTime assay tended to underquantify subtype C (compared to the Xpert and Aptima assays) and subtype A1 samples. The Xpert and Aptima assays were equally efficient for detection of all subtypes and viral loads, which renders these new assays most suitable for clinical HIV laboratories.
机译：在抗逆转录病毒治疗之前和期间进行HIV-1 RNA监测是全球HIV管理不可或缺的一部分。对HIV-1病毒载量的测量有望准确评估所有常见HIV-1亚型的拷贝数，并且在不同病毒载量下同样敏感。在这项研究中，我们首次比较了NucliSens v2.0，RealTime HIV-1，Aptima HIV-1 Quant Dx和Xpert HIV-1病毒载量检测的性能。根据血浆样品的NucliSens v2.0病毒载量结果和HIV-1亚型，选择血浆样品（ n = 404）。评估了一致性，线性回归和Bland-Altman图，并利用混合模型分析比较了不同HIV-1亚型以及低和高HIV-1拷贝数的检测方法的分析性能。总体而言，尽管Xpert和Aptima分析提供了最相似的结果，但所有分析之间均观察到高一致性（> 83.89％），高相关值（Pearson r 值> 0.89）和良好的一致性。输出（估计平均病毒载量分别为2.67日志拷贝/毫升[95％置信区间[CI]，2.50至2.84日志拷贝/毫升]和2.68日志拷贝/毫升[95％CI，2.49至2.86日志拷贝/毫升] ），与RealTime分析的相关性最高（一致性为89.8％，Pearson r 值为0.97至0.98）。这三种检测方法比NucliSens v2.0检测方法显示出更高的精度。所有测定均对亚型B和AG / G样品以及病毒载量为1.60至3.00 log拷贝/ ml的样品同样敏感。 NucliSens v2.0分析法低估了A1样品和病毒载量> 3.00 log拷贝/ ml的样品。实时测定倾向于量化亚型C（与Xpert和Aptima测定相比）和亚型A1样品。 Xpert和Aptima检测对于检测所有亚型和病毒载量同样有效，这使得这些新检测最适合临床HIV实验室。

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