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Clinical and Diagnostic Laboratory Immunology, September 2000, p. 853-855, Vol. 7, No. 5
1071-412X/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.

Semiautomated Quantification of Hepatitis B Virus DNA in a Routine Diagnostic Laboratory

Harald H. Kessler,1,* Evelyn Stelzl,1 Elisabeth Daghofer,1 Brigitte I. Santner,1 Egon Marth,1 Herwig Lackner,2 and Rudolf E. Stauber3

Molecular Diagnostics Laboratory, Institute of Hygiene,1 Department of Pediatrics,2 and Department of Internal Medicine,3 Karl-Franzens-University, A-8010 Graz, Austria

Received 14 April 2000/Returned for modification 20 June 2000/Accepted 13 July 2000

The Cobas Amplicor HBV Monitor test for quantitative determination of hepatitis B virus (HBV) DNA in serum has recently been introduced. To evaluate the performance of this assay in a routine diagnostic laboratory, reproducibility of results was determined with the First European Union Concerted Action HBV Proficiency Panel and the Accurun 325 HBV DNA Positive Control, Series 300. Results for 270 routine serum samples were additionally evaluated. To avoid the retesting of a large number of samples due to titers exceeding the upper limit for the linear range of the assay, sera of patients with chronic hepatitis B (CHB) were diluted prior to the assay to 10-4 in normal human plasma, which is included in the assay. The mean coefficient of variation was 22.9% for all input HBV DNAs. Of 270 routine serum samples, 182 (150 sera from transplant donors and 32 sera from patients who had recovered from CHB) tested negative. Eighty-six sera were found to be HBV DNA positive; in six sera, HBV DNA levels were found to exceed the upper limit for the linear range of the assay and had to be retested. In the remaining two sera, inhibition occurred. The semiautomated Cobas Amplicor HBV Monitor test showed sufficient reproducibility and helped in avoiding human error. The relatively narrow linear range of detection is a limitation of the new assay.

* Corresponding author. Mailing address: Molecular Diagnostics Laboratory, Institute of Hygiene, Karl-Franzens-University Graz, Universitaetsplatz 4, A-8010 Graz, Austria. Phone: 43-316-380-4363. Fax: 43-316-380-9649. E-mail: harald.kessler{at}kfunigraz.ac.at.

Clinical and Diagnostic Laboratory Immunology, September 2000, p. 853-855, Vol. 7, No. 5
1071-412X/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.


This article has been cited by other articles:

  • Konnick, E. Q., Erali, M., Ashwood, E. R., Hillyard, D. R. (2005). Evaluation of the COBAS Amplicor HBV Monitor Assay and Comparison with the Ultrasensitive HBV Hybrid Capture 2 Assay for Quantification of Hepatitis B Virus DNA. J. Clin. Microbiol. 43: 596-603 [Abstract] [Full Text]  
  • Stelzl, E., Muller, Z., Marth, E., Kessler, H. H. (2004). Rapid Quantification of Hepatitis B Virus DNA by Automated Sample Preparation and Real-Time PCR. J. Clin. Microbiol. 42: 2445-2449 [Abstract] [Full Text]  


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