Ortonne Valérie, Wlassow Mélanie, Bouvier-Alias Magali, Melica Giovana, Poveda Jean-Dominique, Laperche Syria, Pawlotsky Jean-Michel, Chevaliez Stephane
National Reference Center for Viral Hepatitis B, C and delta, Department of Virology, hôpital Henri Mondor, Université Paris-Est, 94000 Créteil, France.
Department of Infectious Diseases, hôpital Henri Mondor, 94000 Créteil, France.
Microorganisms. 2021 Mar 11;9(3):573. doi: 10.3390/microorganisms9030573.
(1) Background: Sensitive and accurate nucleic acid amplification technologies are now recommended for hepatitis B virus (HBV) DNA detection and quantification in clinical practice to diagnose and monitor hepatitis B infection. The aim of this study was to assess the analytical and clinical performance of the cobas HBV Test on the cobas 4800 System. (2) Methods: Standard panel and clinical specimens were tested in parallel with three different real-time commercial PCR assays including the cobas HBV Test, the Cobas AmpliPrep/Cobas TaqMan HBV Test v2.0 and Alinity™ HBV assay. (3) Results: The specificity of the cobas HBV Test was 97.9%. The limit of detection was estimated to be 2.1 IU/mL. Intra-assay and interassay coefficients of variation varied from 0.14% to 1.92% and 2.16% to 12.02%, respectively. HBV DNA levels in patients infected with different HBV genotypes strongly correlated with those measured by the two other commercial comparators assays. (4) Conclusions: The cobas HBV Test can be confidently used to detect and accurately quantify HBV DNA in clinical practice as well as in clinical trials with the new anti-HBV drugs currently in development.
(1) 背景：目前在临床实践中，推荐使用灵敏且准确的核酸扩增技术来检测和定量乙型肝炎病毒（HBV）DNA，以诊断和监测乙型肝炎感染。本研究的目的是评估cobas 4800系统上的cobas HBV检测的分析性能和临床性能。(2) 方法：标准品和临床样本与三种不同的实时商业PCR检测方法（包括cobas HBV检测、Cobas AmpliPrep/Cobas TaqMan HBV检测v2.0和Alinity™ HBV检测）进行平行检测。(3) 结果：cobas HBV检测的特异性为97.9%。检测限估计为2.1 IU/mL。批内和批间变异系数分别在0.14%至1.92%和2.16%至12.02%之间。感染不同HBV基因型患者的HBV DNA水平与另外两种商业对照检测方法测得的水平高度相关。(4) 结论：cobas HBV检测可放心用于临床实践以及目前正在研发的新型抗HBV药物的临床试验中，以检测和准确定量HBV DNA。
