Korean J Clin Microbiol.
2007 Apr;10(1):25-31.
Evaluation of a Quantitative RealArt HBV LC PCR Assay for Hepatitis B Virus by Real-time PCR
- Affiliations
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- 1Department of Laboratory Medicine, Wonkwang University College of Medicine, Iksan, Korea.
- 2Department of Pathology, Wonkwang University College of Medicine, Iksan, Korea.
- 3Department of Internal Medicine, Wonkwang University College of Medicine, Iksan, Korea. kimpb@wonkwang.ac.kr
- 4Institute of Wonkwang Medical Science, Wonkwang University College of Medicine, Iksan, Korea.
- 5Wonkwang Clinical Medicine Research Center, Wonkwang University College of Medicine, Iksan, Korea.
- 6Department of Laboratory Medicine, Chonbuk National University College of Medicine, Jeonju, Korea.
Abstract
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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.
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