title: Comparison of the Cobas Ampliprep/Cobas TaqMan HBV Test versus the Cobas Amplicor HBV monitor for HBV-DNA detection and quantification during antiviral therapy.
abstract: Performances of the new automatic system COBAS AmpliPrep/COBAS TaqMan 48 (CAP/CTM) (Roche, Branchburg, NJ) for HBV DNA extraction and real-time PCR quantification were assessed and compared with the endpoint PCR COBAS AMPLICOR HBV Monitor (CAHBM, Roche). Analytical evaluation with proficiency panels from UK National External Quality Assessment Scheme (UK NEQAS) over a 1-year period of distribution showed that CAP/CTM correctly measured HBV DNA levels with a close correlation between expected and observed values (r=0.995). Clinical evaluation as tested with samples from 11 HBsAg-positive patients undergoing antiviral therapy (71 serial specimens of plasma), demonstrated excellent correlation with CAHBM (r=0.958, mean difference in quantitation: 0.14 log, IU/ml), but CAP/CTM detected longer period of residual viremia. HBV DNA reduction was much higher in the combination schedule (Lamivudine+Adefovir), than in Adefovir monotherapy (5.1 vs. 3.5 logs). In conclusion, CAP/CTM allows for an accurate and standardized quantification of HBV DNA in high through-put laboratories. Due to it high sensitivity, it may further improve the detection of emerging drug resistance strains and the assessment of antiviral therapy.
authors.affiliation: Microbiology Laboratory, Molinette Hospital, Turin, Italy.
authors.forename: Tiziano
authors.initials: T
authors.lastname: Allice
authors.forename: Francesco
authors.initials: F
authors.lastname: Cerutti
authors.forename: Fabrizia
authors.initials: F
authors.lastname: Pittaluga
authors.forename: Silvia
authors.initials: S
authors.lastname: Varetto
authors.forename: Silvia
authors.initials: S
authors.lastname: Gabella
authors.forename: Alfredo
authors.initials: A
authors.lastname: Marzano
authors.forename: Alessandro
authors.initials: A
authors.lastname: Franchello
authors.forename: Valeria
authors.initials: V
authors.lastname: Ghisetti
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives / Q000627:therapeutic use; D000998:Antiviral Agents / Q000627:therapeutic use*; D001331:Automation; D004279:DNA, Viral / Q000032:analysis / Q000097:blood* / Q000302:isolation & purification; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000187:drug effects* / Q000235:genetics / Q000302:isolation & purification*; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000821:virology*; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use; D063065:Organophosphonates / Q000627:therapeutic use; D016133:Polymerase Chain Reaction / Q000379:methods*; D019914:Taq Polymerase
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D063065:Organophosphonates; D019259:Lamivudine; C053001:adefovir; D019914:Taq Polymerase; D000225:Adenine