Background: As oral antiviral treatment for chronic hepatitis B increases, quantitation of viral load has become an essential test for HBV management, and assays using real-time PCR principles have been introduced recently.

Methods: We analysed the analytical performance (precision, linear range, and sensitivity) of RealArt HBV LC PCR Reagents (Artus GmbH, Hamburg, Germany), its correlation with COBAS AMPLICOR HBV MONITOR Test (Roche Diagnostics, Mannheim, Germany), and distribution of viral load in the patients’ sera according to antiviral treatment and presence of HBeAg.

Results: Variation of intra-assay and inter-assay were 39.7% and 78.1% at 10³ copies/mL of viral load, 18.1% and 73.2% at 10⁴ copies/mL, and below 10% and below 15% between 10⁵～10⁹copies/mL. Linear range was with 5×10³～2.3×10⁹ copies/mL. Correlation with Amplicor was y=0.9211x+0.607 (R²=0.7801, P＜0.001) and the median concentration in the patients without any treatment was 6.3×10⁷ copies/mL (HBeAg positive) and 3.1×10³copies/mL (HBeAg negative).

Conclusion: RealArt reagent using principles of real-time PCR, would be an appropriate laboratory method for HBV management. (Korean J Clin Microbiol 2007;10:25-31)