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Evaluation of the performance of the Cepheid Xpert HIV-1 Viral Load Assay for quantitative and diagnostic uses.
Journal of Clinical Virology ( IF 4.0 ) Pub Date : 2019-11-15 , DOI: 10.1016/j.jcv.2019.104214
Laura Wesolowski 1 , William Fowler 1 , Wei Luo 1 , Vickie Sullivan 1 , Silvina Masciotra 1 , Tara Smith 2 , Rebecca Rossetti 1 , Kevin Delaney 1 , Emeka Oraka 3 , Pollyanna Chavez 1 , Steven Ethridge 1 , William M Switzer 1 , S Michele Owen 4
Affiliation  

BACKGROUND Cepheid's Xpert HIV-1 Viral Load (Xpert VL), a simplified, automated, single-use quantitative assay used with the GeneXpert System, is not FDA approved. OBJECTIVES Using stored plasma, we conducted a study to assess the ability of Xpert VL to quantify viral load relative to the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 (Cobas VL) and to examine the use of the Xpert VL as a qualitative diagnostic test. STUDY DESIGN Following HIV-1 viral stock dilutions, we conducted a probit analysis to identify the concentration where 95 % of specimens had quantified VLs. We also examined Xpert and Cobas log VL correlation in linearity panels; compared the proportion of 220 seroconverter specimens with virus detected using McNemar's test; and tested specimens from persons with untreated, established HIV-1 infection (n=149) and uninfected persons (n=497). Furthermore, we examined Xpert VL as a qualitative test in seroconverter specimens with early (n=20) and later (n=68) acute infections. RESULTS At 1.80 log10 copies/mL, 95 % of specimens had quantifiable virus using Xpert VL. Xpert and Cobas VLs were highly correlated (R2=0.994). The proportion of seroconverter specimens with virus detected using Cobas and with Xpert VL was not statistically different (p=0.0578). Xpert VL detected 97.9 % of established infections, and specificity was 99.80 % (95 % CI 98.87%-99.99%). Xpert VL detected 90 % and 98.5 % of early and later acute infections, respectively. CONCLUSIONS If approved, Xpert VL could allow U.S. laboratories that cannot bring on large, complex testing platforms to conduct HIV monitoring. An approval for diagnostic use may provide timely identification of HIV infections.

中文翻译:


评估用于定量和诊断用途的 Cepheid Xpert HIV-1 病毒载量测定的性能。



背景 Cepheid 的 Xpert HIV-1 病毒载量 (Xpert VL) 是一种与 GeneXpert 系统一起使用的简化、自动化、一次性定量测定,未经 FDA 批准。目的 使用储存的血浆,我们进行了一项研究,以评估 Xpert VL 相对于罗氏 COBAS AmpliPrep/COBAS TaqMan HIV-1 (Cobas VL) 量化病毒载量的能力,并检验 Xpert VL 作为定性诊断测试的用途。研究设计 HIV-1 病毒原液稀释后,我们进行了概率分析,以确定 95% 的样本具有定量 VL 的浓度。我们还检查了线性面板中的 Xpert 和 Cobas log VL 相关性;比较了 220 份血清转化标本中使用麦克尼马尔检验检测到的病毒的比例;并测试了未经治疗的 HIV-1 感染者 (n=149) 和未感染者 (n=497) 的样本。此外,我们检查了 Xpert VL 作为早期 (n=20) 和晚期 (n=68) 急性感染血清转换器标本的定性测试。结果 使用 Xpert VL,在 1.80 log10 拷贝/mL 时,95% 的样本含有可定量的病毒。 Xpert 和 Cobas VL 高度相关 (R2=0.994)。使用 Cobas 和 Xpert VL 检测到的带有病毒的血清转化样本的比例没有统计学差异 (p=0.0578)。 Xpert VL 检测出 97.9% 的已确诊感染,特异性为 99.80% (95% CI 98.87%-99.99%)。 Xpert VL 分别检测出 90% 和 98.5% 的早期和晚期急性感染。结论 如果获得批准,Xpert VL 可以让无法引入大型、复杂检测平台的美国实验室进行 HIV 监测。诊断用途的批准可以及时识别艾滋病毒感染。
更新日期:2019-11-15
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