Annals of Clinical Microbiology, The official Journal of the Korean Society of Clinical Microbiology


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Indexed in KCI, KoreaMed, Synapse, DOAJ
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pISSN 2288-0585 eISSN 2288-6850

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

Original article

Annals of Clinical Microbiology (Ann Clin Microbiol) 2007 April Volume 10, Issue 1, pages 25-31.

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

Ji-Hyun Cho1,2,3, Hye-Soo Lee4, Key-Earn Lee1,2, Do-Sim Park1,2,3, Young-Jin Lee1,2,3, Hyung-Bae Moon2,3,5, Chang-Soo Choi2,3,6, Eun-Young Cho2,3,6, Haak-Cheoul Kim2,3,6
Departments of 1Laboratory Medicine, 5Pathology and 6Internal Medicine, 2Institute of Wonkwang Medical Science, 3Wonkwang Clinical Medicine Research Center, Wonkwang University College of Medicine, Iksan; 4Department of Laboratory Medicine, Chonbuk National University College of Medicine, Jeonju, Korea


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)


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