Evaluation of the Whole-Blood Alere Q NAT Point-of-Care RNA Assay for HIV-1 Viral Load Monitoring in a Primary Health Care Setting in Mozambique
Evaluation of the Whole-Blood Alere Q NAT Point-of-Care RNA Assay for HIV-1 Viral Load Monitoring in a Primary Health Care Setting in Mozambique
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DOI：
10.1128/jcm.00362-16
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发表时间：
2016-08-01
影响因子：
9.4
通讯作者：
Peter, Trevor F.
中科院分区：
文献类型：
--
作者：
Jani, Ilesh V.;Meggi, Bindiya;Peter, Trevor F.
病毒载量检测是世卫组织推荐的用于接受艾滋病毒抗逆转录病毒治疗的患者的监测检测方法。在资源有限的环境中，即时检测（POC）可能有助于改善病毒载量检测的可及性。我们比较了Alere Q NAT POC病毒载量技术（Alere Technologies, Jena, Germany）的性能，该技术使用在城市周边卫生中心收集的手指刺检毛细管全血样本来测量HIV总RNA，与基于实验室的血浆RNA检测（Roche Cobas Ampliprep/Cobas TaqMan v2）在匹配的静静脉血液样本上进行的检测。与基于实验室的血浆测定相比，全血Alere Q NAT POC测定产生的结果偏差为0.8593 log copy/ml。然而，在超过10,000拷贝/ml时，偏差为0.07 log拷贝/ml。采用who推荐的1000拷贝/ml ART失败阈值，全血Alere Q NAT POC检测的灵敏度和特异性分别为96.83%和47.80%。Alere Q NAT POC检测的全血10,000拷贝/ml的临界值似乎是ART失败阈值（1,000拷贝/ml血浆）的更好预测指标，敏感性为84.0%，特异性为90.3%。在可检测的配对样本之间，全血Alere Q NAT POC测定的精度与实验室技术相当（5.4%对7.5%）。艾滋病毒POC病毒载量检测在初级卫生保健一级是可行的。需要进一步研究全血病毒载量对监测抗逆转录病毒治疗的价值。
Viral load testing is the WHO-recommended monitoring assay for patients on HIV antiretroviral therapy (ART). Point-of-care (POC) assays may help improve access to viral load testing in resource-limited settings. We compared the performance of the Alere Q NAT POC viral load technology (Alere Technologies, Jena, Germany), measuring total HIV RNA using finger prick capillary whole-blood samples collected in a periurban health center, with that of a laboratory-based plasma RNA test (Roche Cobas Ampliprep/Cobas TaqMan v2) conducted on matched venous blood samples. The whole-blood Alere Q NAT POC assay produced results with a bias of 0.8593 log copy/ml compared to the laboratory-based plasma assay. However, at above 10,000 copies/ml, the bias was 0.07 log copy/ml. Using the WHO-recommended threshold to determine ART failure of 1,000 copies/ml, the sensitivity and specificity of the whole-blood Alere Q NAT POC assay were 96.83% and 47.80%, respectively. A cutoff of 10,000 copies/ml of whole blood with the Alere Q NAT POC assay appears to be a better predictor of ART failure threshold (1,000 copies/ml of plasma), with a sensitivity of 84.0% and specificity of 90.3%. The precision of the whole-blood Alere Q NAT POC assay was comparable to that observed with the laboratory technology (5.4% versus 7.5%) between detectable paired samples. HIV POC viral load testing is feasible at the primary health care level. Further research on the value of whole-blood viral load to monitor antiretroviral therapy is warranted.