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Multicenter Evaluation of the Cepheid Xpert ® HBV Viral Load Test |
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Diagnostics (Basel). 2021 Feb 12;11(2):297. doi: 10.3390/diagnostics11020297.
Fabbio Marcuccilli 1, Stephane Chevaliez 2, Thomas Muller 3, Luna Colagrossi 4, Giulia Abbondanza 1, Kurt Beyser 3, Mélanie Wlassow 2, Valérie Ortonne 2, Carlo Federico Perno 4, Marco Ciotti 1
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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.
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