Aptima 病毒学检测在血浆样本中定量检测 HIV-1、HCV 和 HBV 的临床性能评估。
Clinical performance evaluation of the Aptima viral assays for the quantitation of HIV-1, HCV, and HBV in plasma samples.
机构信息
Department of Pathology, Division of Medical Microbiology, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Department of Pathology, Division of Medical Microbiology, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
出版信息
Diagn Microbiol Infect Dis. 2023 Jul;106(3):115951. doi: 10.1016/j.diagmicrobio.2023.115951. Epub 2023 Apr 5.
The clinical performance of the Aptima® HIV-1 Quant Dx, Aptima HCV Quant Dx, and Aptima HBV Quant Dx were evaluated and compared to the Roche cobas HIV-1, HCV, and HBV assays performed on the Roche cobas 6800 system. The Aptima Quant assays exhibited an overall percent agreement of 99.4% for HBV, 98.3% for HCV, and 85.14% for HIV-1. The average log difference between the Aptima and Roche assays was below 0.2 IU (or copies)/mL and the quantitative correlation's (R-squared value (R)) was between 0.95 and 0.97. The Aptima viral assays demonstrated a high level of quantitative correlation with the Roche cobas assays for HCV, HBV, and HIV-1.
对 Aptima® HIV-1 Quant Dx、Aptima HCV Quant Dx 和 Aptima HBV Quant Dx 的临床性能进行了评估，并与在罗氏 cobas 6800 系统上进行的罗氏 cobas HIV-1、HCV 和 HBV 检测进行了比较。Aptima Quant 检测法在乙型肝炎病毒、丙型肝炎病毒和人类免疫缺陷病毒 1 方面的总体百分比一致性分别为 99.4%、98.3%和 85.14%。Aptima 和罗氏检测法之间的平均对数差值低于 0.2IU（或拷贝）/mL，定量相关性（R 平方值（R））在 0.95 到 0.97 之间。Aptima 病毒检测法在丙型肝炎病毒、乙型肝炎病毒和人类免疫缺陷病毒 1 方面与罗氏 cobas 检测法具有高度的定量相关性。
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