Cavidi ExaVir 病毒载量检测法和超敏 P24 检测法与罗氏 Monitor HIV-1 RNA 检测法的性能特征比较。
Performance characteristics of the Cavidi ExaVir viral load assay and the ultra-sensitive P24 assay relative to the Roche Monitor HIV-1 RNA assay.
机构信息
The University of North Carolina at Chapel Hill, Department of Biostatistics, Chapel Hill, NC 27599-7420, USA. paul
出版信息
J Clin Virol. 2010 Nov;49(3):198-204. doi: 10.1016/j.jcv.2010.07.022. Epub 2010 Sep 15.
BACKGROUND
The Cavidi viral load assay and the ultra-sensitive p24 antigen assay (Up24 Ag) have been suggested as more feasible alternatives to PCR-based HIV viral load assays for use in monitoring patients infected with HIV-1 in resource-limited settings.
OBJECTIVES
To describe the performance of the Cavidi ExaVir Load™ assay (version 2.0) and two versions of the Up24 antigen assay and to characterize their agreement with the Roche Monitor HIV-1 RNA assay (version 1.5).
STUDY DESIGN
Observational study using a convenience sample of 342 plasma specimens from 108 patients enrolled in two ACTG clinical trials to evaluate the performance characteristics of the Up24 Ag assay using two different lysis buffers and the Cavidi ExaVir Load™ assay.
RESULTS
In analysis of agreement with the Roche assay, the Cavidi assay demonstrated superiority to the Up24 Ag assays in accuracy and precision, as well as sensitivity, specificity, and positive and negative predictive values for HIV-1 RNA ≥ 400, ≥ 1000 and ≥ 5000 copies/mL. Logistic performance curves indicated that the Cavidi assay was superior to the Up24 assays for viral loads greater than 650 copies/mL.
CONCLUSIONS
The results suggest that the Cavidi ExaVir Load assay could be used for monitoring HIV-1 viral load in resource-limited settings.
背景
Cavidi 病毒载量检测法和超灵敏 p24 抗原检测法（Up24Ag）被认为是在资源有限的环境中替代基于 PCR 的 HIV 病毒载量检测法来监测感染 HIV-1 患者的更可行的选择。
目的
描述 Cavidi ExaVir Load™检测法（版本 2.0）和两种 Up24 抗原检测法的性能，并描述它们与罗氏 Monitor HIV-1 RNA 检测法（版本 1.5）的一致性。
研究设计
采用方便样本的观察性研究，共纳入了两项 ACTG 临床试验中的 108 例患者的 342 份血浆标本，评估两种不同裂解缓冲液的 Up24Ag 检测法和 Cavidi ExaVir Load™检测法的性能特征。
结果
在与罗氏检测法的一致性分析中，Cavidi 检测法在准确性、精密度以及敏感性、特异性和 HIV-1 RNA≥400、≥1000 和≥5000 拷贝/ml 的阳性和阴性预测值方面优于 Up24Ag 检测法。逻辑性能曲线表明，对于病毒载量大于 650 拷贝/ml 的样本，Cavidi 检测法优于 Up24 检测法。
结论
研究结果表明，Cavidi ExaVir Load 检测法可用于资源有限环境中的 HIV-1 病毒载量监测。
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