Korean Journal of Clinical Microbiology  2007;10(1):25-31

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

Ji Hyun CHO 1 ; Hye Soo LEE ; Key Earn LEE ; Do Sim PARK ; Young Jin LEE ; Hyung Bae MOON ; Chang Soo CHOI ; Eun Young CHO ; Haak Cheoul KIM

Affiliations

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Keywords

Hepatitis B virus; HBV DNA assay; Real-time PCR

Country

Republic of Korea

Language

Korean

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.