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KMID : 0829320070100010025
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Korean Journal of Clinical Microbiology
2007 Volume.10 No. 1 p.25 ~ p.31
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Evaluation of a Quantitative RealArt HBV LC PCR Assay for Hepatitis B Virus by Real-time PCR
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Cho Ji-Hyun
Lee Hye-Soo
Lee Key-Eun
Park Do-Sim
Lee Young-Jin
Moon Hyung-Bae
Choi Chang-Soo
Cho Eun-Young
Kim Haak-Cheoul
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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 103 copies/mL of viral load,
18.1% and 73.2% at 104 copies/mL, and below 10% and below 15% between 105～109 copies/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 3.1×103 copies/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)
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KEYWORD
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Hepatitis B virus, HBV DNA assay, Real-time PCR
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