Evaluation of a Quantitative RealArt HBV LC PCR Assay for Hepatitis B Virus by Real-time PCR / 대한임상미생물학회지

ABSTRACT

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 10(3) copies/mL of viral load, 18.1% and 73.2% at 10(4) copies/mL, and below 10% and below 15% between 10(5)~10(9) copies/mL. Linear range was with 5x10(3)~2.3x10(9) copies/mL. Correlation with Amplicor was y=0.9211x+0.607 (R(2)=0.7801, P<0.001) and the median concentration in the patients without any treatment was 6.3x10(7) copies/mL (HBeAg positive) and 3.1x10(3) copies/mL (HBeAg negative). CONCLUSION: RealArt reagent using principles of real-time PCR, would be an appropriate laboratory method for HBV management.