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Article

Multicenter Evaluation of the Cepheid Xpert® HBV Viral Load Test

1
Laboratory of Virology, Virology Unit, Polyclinic Tor Vergata Foundation, Viale Oxford, 81, 00133 Rome, Italy
2
National Reference Center for Viral Hepatitis B, C and Delta, Department of Virology, Hôpital Henri Mondor, Université Paris-Est, 94010 Créteil, France
3
Medizinisches Versorgungszentrum Labor München Zentrum GbR, SYNLAB MVZ, 92637 Weiden, Germany
4
Area of Multimodal Medicine and Laboratory, Children Hospital Bambino Gesù, 00165 Rome, Italy
*
Author to whom correspondence should be addressed.
Academic Editor: Nuno Taveira
Diagnostics 2021, 11(2), 297; https://doi.org/10.3390/diagnostics11020297
Received: 30 December 2020 / Revised: 5 February 2021 / Accepted: 8 February 2021 / Published: 12 February 2021
(This article belongs to the Collection Diagnostic Virology)
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. View Full-Text
Keywords: Xpert® HBV viral load assay; CAP/CTM HBV test; v.2; HBV DNA quantification Xpert® HBV viral load assay; CAP/CTM HBV test; v.2; HBV DNA quantification
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MDPI and ACS Style

Marcuccilli, F.; Chevaliez, S.; Muller, T.; Colagrossi, L.; Abbondanza, G.; Beyser, K.; Wlassow, M.; Ortonne, V.; Perno, C.F.; Ciotti, M. Multicenter Evaluation of the Cepheid Xpert® HBV Viral Load Test. Diagnostics 2021, 11, 297. https://doi.org/10.3390/diagnostics11020297

AMA Style

Marcuccilli F, Chevaliez S, Muller T, Colagrossi L, Abbondanza G, Beyser K, Wlassow M, Ortonne V, Perno CF, Ciotti M. Multicenter Evaluation of the Cepheid Xpert® HBV Viral Load Test. Diagnostics. 2021; 11(2):297. https://doi.org/10.3390/diagnostics11020297

Chicago/Turabian Style

Marcuccilli, Fabbio, Stephane Chevaliez, Thomas Muller, Luna Colagrossi, Giulia Abbondanza, Kurt Beyser, Mélanie Wlassow, Valérie Ortonne, Carlo F. Perno, and Marco Ciotti. 2021. "Multicenter Evaluation of the Cepheid Xpert® HBV Viral Load Test" Diagnostics 11, no. 2: 297. https://doi.org/10.3390/diagnostics11020297

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