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].