Introduction of an Automated System for the Diagnosis and Quantification of Hepatitis B and Hepatitis C Viruses

Table 1.: Commercial Assays for HBV DNA Quantitation

Methods	Lower Limit of Detection (LLD)	Automation
Hibridizations methods
Hybrid capture Ultrasensitive hybrid capture II (Digene, MD, USA)	8x10 3 copies/mL	Semiautomated
Branched DNA VERSANT hepatitis B virus DNA 3.0 (Bayer Healthcare LLC, NY, USA)	3,3x10 3copies/mL
Convencional PCR
PCR COBAS Amplicor HBV Monitor	2x10 2 copies/mL	Semiautomated
Real Time
Abbott PCR (Abbott, Weisbaden, Germany)	10 IU/mL for 500ul 15 IU/ml for 200ul	Automated
Smart HBVTM (Cepheid,		Automated
Real Art HBV (Artus GmbH, Hamburg, Germany)	10.2 IU/mL	Automated
COBAS AmPliprep (Roche Diagnostics, NJ, USA; with total nucleic acid isolation)	20 IU/mL	Automated
Cobas TaqMan HBV (Roche Diagnostic)	6-10 IU/mL	Automated
Aptima HBV Quantitative assay (Gen-Probe, San Diego, CA)	Available in 2012

The lower limits of detection of these systems were established against the WHO international standards for HBV DNA. Probit analysis showed the LLODs of the at 95% CI. Of these methods, only real-time PCR is able to cover t he wide dynamic range required for quantification of the virus in all stages of infection - 10 to 109 IU/mL [⁷,²³,²⁸].