Marcuccilli Fabbio, Chevaliez Stephane, Muller Thomas, Colagrossi Luna, Abbondanza Giulia, Beyser Kurt, Wlassow Mélanie, Ortonne Valérie, Perno Carlo Federico, Ciotti Marco
Laboratory of Virology, Virology Unit, Polyclinic Tor Vergata Foundation, Viale Oxford, 81, 00133 Rome, Italy.
National Reference Center for Viral Hepatitis B, C and Delta, Department of Virology, Hôpital Henri Mondor, Université Paris-Est, 94010 Créteil, France.
Diagnostics (Basel). 2021 Feb 12;11(2):297. doi: 10.3390/diagnostics11020297.
Accurate measurement of the hepatitis B virus (HBV) DNA is important for the management of patients with chronic HBV infection. Here, the performance of the Xpert HBV Viral Load test (Xpert HBV Viral Load) versus the Roche COBAS Ampliprep/COBAS TaqMan system (CAP/CTM HBV) HBV test v2.0 was evaluated. From September 2017 to December 2017, a total of 876 prospectively collected or archived serum or EDTA plasma specimens from subjects chronically infected with HBV were tested using the Xpert HBV Viral Load and the CAP/CTM HBV v2.0 assays. Of the 876 specimens tested, 560 were within the quantitative range of both assays. The agreement between the two methods was 90.0%. No difference in plasma or serum samples was observed. Deming regression analysis showed a good correlation of the Xpert HBV Viral Load assay with the CAP/CTM HBV v2.0 assay. The Bland-Altman analysis showed a good agreement between the results of the Xpert HBV Viral Load assay and the CAP/CTM HBV assay, with a mean difference (±1.96 standard deviation) of 0.0091 ± 0.3852 Log IU/mL. Comparing the two assays, only nineteen specimens (2.1%) had a difference greater than 1.96 times the standard deviation. The Xpert HBV Viral Load test is suitable for monitoring patients with HBV infection and is useful in diagnostic settings.
准确测量乙型肝炎病毒(HBV)DNA对于慢性HBV感染患者的管理至关重要。在此,对Xpert HBV病毒载量检测(Xpert HBV Viral Load)与罗氏COBAS Ampliprep/COBAS TaqMan系统(CAP/CTM HBV)HBV检测v2.0的性能进行了评估。2017年9月至2017年12月,使用Xpert HBV病毒载量检测和CAP/CTM HBV v2.0检测方法对总共876份前瞻性收集或存档的慢性HBV感染受试者的血清或乙二胺四乙酸(EDTA)血浆标本进行了检测。在检测的876份标本中,560份在两种检测方法的定量范围内。两种方法之间的一致性为90.0%。未观察到血浆或血清样本存在差异。Deming回归分析显示Xpert HBV病毒载量检测与CAP/CTM HBV v2.0检测具有良好的相关性。Bland-Altman分析显示Xpert HBV病毒载量检测结果与CAP/CTM HBV检测结果之间具有良好的一致性,平均差异(±1.96标准差)为0.0091±0.3852 Log IU/mL。比较这两种检测方法,只有19份标本(2.1%)的差异大于1.96倍标准差。Xpert HBV病毒载量检测适用于监测HBV感染患者,在诊断环境中也很有用。