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Abstract Details
Multicenter Evaluation of the Cepheid Xpert ® HBV Viral Load Test
Diagnostics (Basel). 2021 Feb 12;11(2):297. doi: 10.3390/diagnostics11020297.
Fabbio Marcuccilli1, Stephane Chevaliez2, Thomas Muller3, Luna Colagrossi4, Giulia Abbondanza1, Kurt Beyser3, Mélanie Wlassow2, Valérie Ortonne2, Carlo Federico Perno4, Marco Ciotti1
Author information
1Laboratory of Virology, Virology Unit, Polyclinic Tor Vergata Foundation, Viale Oxford, 81, 00133 Rome, Italy.
2National Reference Center for Viral Hepatitis B, C and Delta, Department of Virology, Hôpital Henri Mondor, Université Paris-Est, 94010 Créteil, France.
3Medizinisches Versorgungszentrum Labor München Zentrum GbR, SYNLAB MVZ, 92637 Weiden, Germany.
4Area of Multimodal Medicine and Laboratory, Children Hospital Bambino Gesù, 00165 Rome, Italy.
Abstract
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.