title: The New Aptima HBV Quant Real-Time TMA Assay Accurately Quantifies Hepatitis B Virus DNA from Genotypes A to F.
abstract: Sensitive and accurate hepatitis B virus (HBV) DNA detection and quantification are essential to diagnose HBV infection, establish the prognosis of HBV-related liver disease, and guide the decision to treat and monitor the virological response to antiviral treatment and the emergence of resistance. Currently available HBV DNA platforms and assays are generally designed for batching multiple specimens within an individual run and require at least one full day of work to complete the analyses. The aim of this study was to evaluate the ability of the newly developed, fully automated, one-step Aptima HBV Quant assay to accurately detect and quantify HBV DNA in a large series of patients infected with different HBV genotypes. The limit of detection of the assay was estimated to be 4.5 IU/ml. The specificity of the assay was 100%. Intra-assay and interassay coefficients of variation ranged from 0.29% to 5.07% and 4.90% to 6.85%, respectively. HBV DNA levels from patients infected with HBV genotypes A to F measured with the Aptima HBV Quant assay strongly correlated with those measured by two commercial real-time PCR comparators (Cobas AmpliPrep/Cobas TaqMan HBV test, version 2.0, and Abbott RealTime HBV test). In conclusion, the Aptima HBV Quant assay is sensitive, specific, and reproducible and accurately quantifies HBV DNA in plasma samples from patients with chronic HBV infections of all genotypes, including patients on antiviral treatment with nucleoside or nucleotide analogues. The Aptima HBV Quant assay can thus confidently be used to detect and quantify HBV DNA in both clinical trials with new anti-HBV drugs and clinical practice.
authors.affiliation: National Reference Center for Viral Hepatitis B, C, and Delta, Department of Virology, Hôpital Henri Mondor, Université Paris-Est, Créteil, France stephane.chevaliez@aphp.fr.|INSERM U955, Créteil, France.
authors.forename: Stéphane
authors.initials: S
authors.lastname: Chevaliez
authors.affiliation: National Reference Center for Viral Hepatitis B, C, and Delta, Department of Virology, Hôpital Henri Mondor, Université Paris-Est, Créteil, France.
authors.forename: Claude
authors.initials: C
authors.lastname: Dauvillier
authors.affiliation: National Reference Center for Viral Hepatitis B, C, and Delta, Department of Virology, Hôpital Henri Mondor, Université Paris-Est, Créteil, France.
authors.forename: Fabienne
authors.initials: F
authors.lastname: Dubernet
authors.affiliation: Laboratoire Cerba, Cergy-Pontoise, France.
authors.forename: Jean-Dominique
authors.initials: JD
authors.lastname: Poveda
authors.affiliation: National Reference Center for Viral Hepatitis B, C, and Delta in Blood Transfusion, Institut National de la Transfusion Sanguine, Paris, France.
authors.forename: Syria
authors.initials: S
authors.lastname: Laperche
authors.affiliation: INSERM U955, Créteil, France.|Department of Hepatology, Hôpital Henri Mondor, Université Paris-Est, Créteil, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Hézode
authors.affiliation: National Reference Center for Viral Hepatitis B, C, and Delta, Department of Virology, Hôpital Henri Mondor, Université Paris-Est, Créteil, France.|INSERM U955, Créteil, France.
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Pawlotsky
mesh_terms: D057205:Automation, Laboratory / Q000379:methods; D004247:DNA / Q000032:analysis*; D005838:Genotype; D006509:Hepatitis B / Q000821:virology; D006515:Hepatitis B virus / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D010949:Plasma / Q000821:virology; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D019562:Viral Load / Q000379:methods*
chemical_list: D004247:DNA
keywords: HBV DNA; HBV monitoring; hepatitis B virus; real-time TMA