Point-of-Care Cepheid Xpert HIV-1 Viral Load Test in Rural African Communities Is Feasible and Reliable
Point-of-Care Cepheid Xpert HIV-1 Viral Load Test in Rural African Communities Is Feasible and Reliable
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DOI：
10.1128/jcm.01594-16
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发表时间：
2016-12-01
影响因子：
9.4
通讯作者：
Novitsky, Vladimir
中科院分区：
文献类型：
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作者：
Moyo, Sikhulile;Mohammed, Terence;Novitsky, Vladimir
对接受抗逆转录病毒治疗(ART)的患者进行HIV-1RNA或病毒载量(VL)的常规监测很重要，但在资源有限的情况下进行VL检测存在多种障碍。准确的临床点(POC)HIV-1VL检测可以缓解许多这些挑战。我们比较了Cepheid Xpert HIV-1 VL检测和基于实验室的Abbott m2000sp/m2000rt检测(Abbott检测)的性能。在20个社区参与博茨瓦纳联合预防项目的艺术天真的个人在家庭调查期间提供了EDTA血样。对277名个体的样本进行了POC Xpert HIV-1 VL和Abbott检测。我们发现Xpert HIV-1VL和雅培试验结果之间有很高的相关性(r(2)=0.92p<；0.001)。Xpert HIV-1VL法和Abbott法获得的HIV-1RNA值的总体平均差异为0.34log(10)Copies/ml(95%可信区间[CI]，0.26至0.40log(10)Copies/ml)(P<；0.001)。以1,000拷贝/ml为临界值，诊断符合率为90.6%(95%CI，87.9%~93.1%)，敏感性为98.6%(95%CI，97.2%~100%)。两种方法对HIV-1RNA(40拷贝/ml)的检测率为97.1%(95%CI，95.5%~98.7%)，敏感性为99.6%(95%CI，97.2%~100%)。POC Cepheid Xpert HIV-1VL检测方法与基于实验室的HIV-1RNA检测方法显示出高度的一致性和准确性。POC Xpert HIV-1 VL试验倾向于高估HIV-1 VL，尽管这一差异低于临床相关阈值0.5log(10)Copies/ml。POC Cepheid Xpert HIV-1 VL试验是监测南部非洲接受抗逆转录病毒治疗患者的一种有前途的工具。
Routine monitoring of HIV-1 RNA or viral load (VL) in patients on antiretroviral therapy (ART) is important, but there are multiple impediments to VL testing in resource-constrained settings. An accurate point-of-care (POC) HIV-1 VL test could alleviate many of these challenges. We compared the performance of the Cepheid Xpert HIV-1 VL assay against the laboratory-based Abbott m2000sp/m2000rt assay (Abbott assay). ART-naive individuals participating in the Botswana Combination Prevention Project in 20 communities provided EDTA-blood specimens during household surveys. Both the POC Xpert HIV-1 VL and Abbott assays were performed on specimens sampled from 277 individuals. We found a high correlation between the Xpert HIV-1 VL and Abbott assay results (r(2) = 0.92; P < 0.001). The overall mean difference in the HIV-1 RNA values obtained by Xpert HIV-1 VL assay and Abbott assay was 0.34 log(10) copies/ml (95% confidence interval [CI], 0.26 to 0.40 log(10) copies/ml) (P < 0.001). Using a clinically relevant level of 1,000 copies/ml as a threshold, agreement was 90.6% (95% CI, 87.9 to 93.1%), with a sensitivity of 98.6% (95% CI, 97.2 to 100%). The two methods agreed on their detectability of HIV-1 RNA (>40 copies/ml) at 97.1% (95% CI, 95.5 to 98.7%), with a sensitivity of 99.6% (95% CI, 97.2 to 100%). The POC Cepheid Xpert HIV-1 VL assay showed high agreement and accuracy with a laboratory-based method of HIV-1 RNA testing. The POC Xpert HIV-1 VL assay tended to overestimate HIV-1 VL, although the difference was below a clinically relevant threshold of 0.5 log(10) copies/ml. The POC Cepheid Xpert HIV-1 VL assay is a promising tool for monitoring patients on ART in southern Africa.