Rapid Communication
Copyright ©2008 The WJG Press and Baishideng. All rights reserved.
World J Gastroenterol. Jan 21, 2008; 14(3): 479-483
Published online Jan 21, 2008. doi: 10.3748/wjg.14.479
Comparison of real-time polymerase chain reaction with the COBAS Amplicor test for quantitation of hepatitis B virus DNA in serum samples
Ming Shi, Yong Zhang, Ying-Hua Zhu, Jing Zhang, Wei-Jia Xu
Ming Shi, Yong Zhang, Ying-Hua Zhu, Laboratory Center, No. 6 Hospital of Dalian, Dalian 116001, Liaoning Province, China
Jing Zhang, Wei-Jia Xu, Laboratory Center, Dalian Central Hospital, Dalian 116001, Liaoning Province, China
Correspondence to: Ming Shi, Laboratory Center, No. 6 Hospital of Dalian, 1 Chunhai Street, Dalian 116001, Liaoning Province, China. zhsh6655@sohu.com
Telephone: +86-411-82714773
Fax: +86-411-82714773
Received: July 10, 2007
Revised: August 30, 2007
Published online: January 21, 2008
Abstract

AIM: To compare the clinical performance of a real-time PCR assay with the COBAS Amplicor Hepatitis B Virus (HBV) Monitor test for quantitation of HBV DNA in serum samples.

METHODS: The reference sera of the Chinese National Institute for the Control of Pharmaceutical and Biological Products and the National Center for Clinical Laboratories of China, and 158 clinical serum samples were used in this study. The linearity, accuracy, reproducibility, assay time, and costs of the real-time PCR were evaluated and compared with those of the Cobas Amplicor test.

RESULTS: The intra-assay and inter-assay variations of the real-time PCR ranged from 0.3% to 3.8% and 1.4% to 8.1%, respectively. The HBV DNA levels measured by the real-time PCR correlated very well with those obtained with the COBAS Amplicor test (r = 0.948). The real-time PCR HBV DNA kit was much cheaper and had a wider dynamic range.

CONCLUSION: The real-time PCR assay is an excellent tool for monitoring of HBV DNA levels in patients with chronic hepatitis B.

Keywords: COBAS Amplicor test; Hepatitis B virus; Viral DNA; Real-time PCR