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


CONCLUSIONS
The real-time PCR assay is an excellent tool for monitoring of HBV DNA levels in patients with chronic hepatitis B.
Shi
Ming
M
Laboratory Center, No. 6 Hospital of Dalian, 1 Chunhai Street, Dalian 116001, Liaoning Province, China. zhsh6655@sohu.com
Zhang
Yong
Y
Zhu
Ying-Hua
YH
Zhang
Jing
J
Xu
Wei-Jia
WJ
D004279:DNA, Viral / Q000097:blood*; D006509:Hepatitis B / Q000097:blood / Q000175:diagnosis; D006515:Hepatitis B virus / Q000235:genetics*; D006801:Humans; D016133:Polymerase Chain Reaction / Q000191:economics / Q000379:methods / Q000592:standards; D011933:Reagent Kits, Diagnostic / Q000191:economics / Q000592:standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D019562:Viral Load
D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic