Valérie Ortonne1, Mélanie Wlassow1, Magali Bouvier-Alias1, Giovana Melica2, Jean-Dominique Poveda3, Syria Laperche4, Jean-Michel Pawlotsky1, Stephane Chevaliez1. 1. National Reference Center for Viral Hepatitis B, C and delta, Department of Virology, hôpital Henri Mondor, Université Paris-Est, 94000 Créteil, France. 2. Department of Infectious Diseases, hôpital Henri Mondor, 94000 Créteil, France. 3. Laboratoire Cerba, Department of Infectious Diseases, 95310 Cergy-Pontoise, France. 4. National Institute of Blood Transfusion, Department of Blood-Borne Agents, National Reference Center for Infectious Risks in Transfusion, 75015 Paris, France.
Abstract
(1) Background: Sensitive and accurate nucleic acid amplification technologies are now recommended for hepatitis B virus (HBV) DNA detection and quantification in clinical practice to diagnose and monitor hepatitis B infection. The aim of this study was to assess the analytical and clinical performance of the cobas® HBV Test on the cobas® 4800 System. (2) Methods: Standard panel and clinical specimens were tested in parallel with three different real-time commercial PCR assays including the cobas ® HBV Test, the Cobas® AmpliPrep/Cobas® TaqMan HBV Test v2.0 and Alinity™ m HBV assay. (3) Results: The specificity of the cobas® HBV Test was 97.9%. The limit of detection was estimated to be 2.1 IU/mL. Intra-assay and interassay coefficients of variation varied from 0.14% to 1.92% and 2.16% to 12.02%, respectively. HBV DNA levels in patients infected with different HBV genotypes strongly correlated with those measured by the two other commercial comparators assays. (4) Conclusions: The cobas® HBV Test can be confidently used to detect and accurately quantify HBV DNA in clinical practice as well as in clinical trials with the new anti-HBV drugs currently in development.
(1) Background: Sensitive and accurate nucleic acid amplification technologies are now recommended for hepatitis B virus (HBV) DNA detection and quantification in clinical practice to diagnose and monitor hepatitis B infection. The aim of this study was to assess the analytical and clinical performance of the cobas® HBV Test on the cobas® 4800 System. (2) Methods: Standard panel and clinical specimens were tested in parallel with three different real-time commercial PCR assays including the cobas ® HBV Test, the Cobas® AmpliPrep/Cobas® TaqMan HBV Test v2.0 and Alinity™ m HBV assay. (3) Results: The specificity of the cobas® HBV Test was 97.9%. The limit of detection was estimated to be 2.1 IU/mL. Intra-assay and interassay coefficients of variation varied from 0.14% to 1.92% and 2.16% to 12.02%, respectively. HBV DNA levels in patientsinfected with different HBV genotypes strongly correlated with those measured by the two other commercial comparators assays. (4) Conclusions: The cobas® HBV Test can be confidently used to detect and accurately quantify HBV DNA in clinical practice as well as in clinical trials with the new anti-HBV drugs currently in development.
Entities:
Keywords:
HBV DNA; HBV monitoring; hepatitis B infection diagnosis; hepatitis B virus; real-time PCR
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