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Journal of Clinical Microbiology, November 2004, p. 5199-5204, Vol. 42, No. 11
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.11.5199-5204.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

Assessment of the Target-Capture PCR Hepatitis B Virus (HBV) DNA Quantitative Assay and Comparison with Commercial HBV DNA Quantitative Assays

Venkatakrishna Shyamala,* Phillip Arcangel, Joshua Cottrell, Doris Coit, Angelica Medina-Selby, Colin McCoin, Dennis Madriaga, David Chien, and Bruce Phelps

Blood Testing Division, Chiron Corporation, Emeryville, California

Received 13 February 2004/ Returned for modification 11 May 2004/ Accepted 11 August 2004

Recent clinical studies suggest that hepatitis B virus (HBV) load and genotype may be independent predictors of responses to antiviral therapies. However, it is difficult for clinicians to accurately determine viral loads in patient samples because results—both the values and the units of measure—can vary greatly among different tests. Accordingly, the World Health Organization (WHO) has produced the first international standard for HBV DNA for nucleic acid amplification technology (NAT) assays. In the present study, we describe the performance of the target-capture PCR HBV DNA quantitative assay for the quantitation of HBV DNA in clinical samples and reference panels. The range of quantitation was between 50 and 1010 IU/ml. The sensitivity and accuracy of the target-capture PCR assay were demonstrated by using the HBV panel from Quality Control for Medical Diagnostics (QCMD) and the WHO HBV DNA standard. The target-capture PCR assay quantitated the six genotype A members of the QCMD panel and dilutions of the WHO HBV DNA standard within an accuracy of 74 to 142%. Compared to current serological methods, the assay offers window period reductions of 19 days prior to HBV surface antigen and 26 days prior to HBV e antigen detection. The target-capture PCR assay was also compared with four commercially available NAT assays, and the various units of measure were standardized with respect to the international units of the WHO HBV DNA standard. The target-capture PCR assay is a sensitive, accurate, high-throughput, rapid, and reproducible assay for the determination of HBV loads.

* Corresponding author. Mailing address: Chiron Corporation, 4560 Horton St., 4.305, Emeryville, CA 94608. Phone: (510) 923-2932. Fax: (510) 923-2586. E-mail: V_Shyamala{at}chiron.com.

Journal of Clinical Microbiology, November 2004, p. 5199-5204, Vol. 42, No. 11
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.11.5199-5204.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.



This article has been cited by other articles:

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