Comparison of real-time polymerase chain reaction with the COBAS Amplicor test for quantitation of hepatitis B virus DNA in serum samples  

作　　者：Ming Shi Yong Zhang Ying-Hua Zhu Jing Zhang Wei-Jia Xu 

机构地区：[1]Laboratory Center, No. 6 Hospital of Dalian, Dalian 116001, Liaoning Province, China [2]Laboratory Center, Dalian Central Hospital, Dalian 116001, Liaoning Province, China

出　　处：《World Journal of Gastroenterology》2008年第3期479-483,共5页世界胃肠病学杂志（英文版）

摘　　要：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.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.

关 键 词：COBAS Amplicor test Hepatitis B virus Viral DNA Real-time PCR 

分 类 号：R512.62[医药卫生—内科学]