Multicenter Evaluation of the Cepheid Xpert<sup>®</sup> HBV Viral Load Test
Fabbio Marcuccilli,
Stephane Chevaliez,
Thomas Muller,
Luna Colagrossi,
Giulia Abbondanza,
Kurt Beyser,
Mélanie Wlassow,
Valérie Ortonne,
Carlo Federico Perno,
Marco Ciotti
Affiliations
Fabbio Marcuccilli
Laboratory of Virology, Virology Unit, Polyclinic Tor Vergata Foundation, Viale Oxford, 81, 00133 Rome, Italy
Stephane Chevaliez
National Reference Center for Viral Hepatitis B, C and Delta, Department of Virology, Hôpital Henri Mondor, Université Paris-Est, 94010 Créteil, France
Thomas Muller
Medizinisches Versorgungszentrum Labor München Zentrum GbR, SYNLAB MVZ, 92637 Weiden, Germany
Luna Colagrossi
Area of Multimodal Medicine and Laboratory, Children Hospital Bambino Gesù, 00165 Rome, Italy
Giulia Abbondanza
Laboratory of Virology, Virology Unit, Polyclinic Tor Vergata Foundation, Viale Oxford, 81, 00133 Rome, Italy
Kurt Beyser
Medizinisches Versorgungszentrum Labor München Zentrum GbR, SYNLAB MVZ, 92637 Weiden, Germany
Mélanie Wlassow
National Reference Center for Viral Hepatitis B, C and Delta, Department of Virology, Hôpital Henri Mondor, Université Paris-Est, 94010 Créteil, France
Valérie Ortonne
National Reference Center for Viral Hepatitis B, C and Delta, Department of Virology, Hôpital Henri Mondor, Université Paris-Est, 94010 Créteil, France
Carlo Federico Perno
Area of Multimodal Medicine and Laboratory, Children Hospital Bambino Gesù, 00165 Rome, Italy
Marco Ciotti
Laboratory of Virology, Virology Unit, Polyclinic Tor Vergata Foundation, Viale Oxford, 81, 00133 Rome, Italy
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.
