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Journal of Clinical Microbiology, June 2000, p. 2150-2155, Vol. 38, No. 6
0095-1137/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.

A Multicenter Study Evaluation of the Digene Hybrid Capture II Signal Amplification Technique for Detection of Hepatitis B Virus DNA in Serum Samples and Testing of EUROHEP Standards

Hubert G. M. Niesters,1,* Mel Krajden,2 Lynda Cork,2 Maria de Medina,3 Mary Hill,3 Edwin Fries,1 and Albert D. M. E. Osterhaus1

Department of Virology, University Hospital Rotterdam, Rotterdam, The Netherlands1; Toronto Medical Laboratories, The Toronto Hospital, Toronto, Ontario, Canada2; and Center for Liver Diseases, University of Miami School of Medicine, Miami, Florida3

Received 30 September 1999/Returned for modification 28 December 1999/Accepted 10 March 2000

We have evaluated the new Digene Hybrid Capture II HBV DNA Test (HCII HBV), which is a 96-well microtiter plate-based signal amplification assay. This test uses hybrid capture technology that specifically detects RNA-DNA hybrids. HCII HBV is able to quantify hepatitis B virus (HBV) DNA at between 1.4 × 105 and 1.7 × 109 HBV copies per ml in a standard format. By using a modified sample preparation method, which allows the input of 30-fold more serum for an ultrasensitive format, the sensitivity of the assay can be increased reproducibly to approximately 8,000 copies of HBV per ml. By using a combination of these two formats, the assay can quantify over a total range of 6 logs. In our multicenter evaluation study, the mean laboratory-to-laboratory coefficients of variation were 22, 7, and 12% at the three sites, respectively, with a combined specificity of 98.4%. The linearities of both the standard test and the ultrasensitive test were excellent, with Spearman correlation coefficients of 0.997 and 0.999, respectively. Furthermore, the intra-assay reproducibility for the standard assay gave coefficients of variation of from 13 to 33, 9 to 21, and 3 to 8% at the three sites, respectively. HCII HBV was shown to be genotype independent when the EUROHEP standards for genotypes A and D were used. This assay allows the accurate measurement of HBV DNA levels in serum and can be clinically used for the monitoring of responses to antiviral agents for patients chronically infected with HBV.

* Corresponding author. Mailing address: Department of Virology, University Hospital Rotterdam, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands. Phone: 31-10-463.3431. Fax: 31-10-463.3441. E-mail: niesters{at}viro.fgg.eur.nl.

Journal of Clinical Microbiology, June 2000, p. 2150-2155, Vol. 38, No. 6
0095-1137/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.


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