Real-time PCR per HBV DNA: valutazione del nuovo sistema automatizzato COBAS AMPLIPREP™/COBAS TAQMAN™ HBV


Submitted: 17 February 2014
Accepted: 17 February 2014
Published: 31 December 2007
Abstract Views: 1071
PDF: 1599
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Authors

Success of antiviral therapy for chronic hepatitis B is supported by highly sensitive PCR-based assays for Hepatitis B virus (HBV) DNA. Nucleic acid extraction from biologic specimens is technically demanding and reliable PCR results depend it. Performances of the fully 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 end-point PCR COBAS AMPLICOR HBV Monitor (CAHBM, Roche). Analytical evaluation with a proficiency panel showed that CAP/CTM quantitated HBV DNA levels in one single run over a wide dynamic range (7 logs) with a close correlation between expected and observed values (r=0.976, interassay variability below 5%). Clinical evaluation as tested with samples from 92 HBsAg-positive patients, demonstrated excellent correlation with CAHBM (r=0.966, mean difference in quantitation: 0.36 log10 IU/ml). CAP/CTM detected 10% more viremic patients and longer period of residual viremia in those on therapy. In lamivudine (LAM)-resistant patients, reduction of HBV DNA after 12 months of Adefovir (ADF) was higher in the combination (LAM+ADF) schedule than in ADF monotherapy (5.1 vs. 3.5 logs) suggesting a benefit in continuing LAM. In conclusion,CAP/CTM can improve the management of HBV infection, the assessment of antiviral therapy and drug resistance, supporting further insights in the emerging area of drug resistance.

Allice, T., Cerutti, F., Pittaluga, F., Varetto, S., Gabella, S., Marzano, A., Franchello, A., & Ghisetti, V. (2007). Real-time PCR per HBV DNA: valutazione del nuovo sistema automatizzato COBAS AMPLIPREP™/COBAS TAQMAN™ HBV. Microbiologia Medica, 22(4). https://doi.org/10.4081/mm.2007.2606

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