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Journal of Clinical Microbiology, April 2006, p. 1490-1494, Vol. 44, No. 4
0095-1137/06/$08.00+0     doi:10.1128/JCM.44.4.1490-1494.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

Quantification of Hepatitis B Virus (HBV) DNA with a TaqMan HBV Analyte-Specific Reagent following Sample Processing with the MagNA Pure LC Instrument

Jeffrey J. Germer,¹ Mohammed O. Qutub,³ Jayawant N. Mandrekar,² P. Shawn Mitchell,¹ and Joseph D. C. Yao^1*

Division of Clinical Microbiology,¹ Section of Biostatistics, Mayo Clinic, Rochester, Minnesota,² Department of Pathology and Laboratory Medicine, King Faisal Specialist Hospital, Riyadh, Saudi Arabia³

Received 9 November 2005/ Returned for modification 24 January 2006/ Accepted 2 February 2006

TaqMan hepatitis B virus (HBV) analyte-specific reagent (ASR; Roche Molecular Systems, Inc., Branchburg, NJ) is designed for the quantification of HBV DNA in serum or plasma. The performance characteristics of TaqMan HBV ASR following automated sample processing with the MagNA Pure LC instrument (MP; Roche Applied Science, Indianapolis, IN) were evaluated in this study. Analytical sensitivity and precision were assessed with commercially available HBV standards, while clinical serum specimens from HBsAg-seropositive patients and healthy blood donors were used to determine clinical sensitivity, specificity, and correlation with other commercially available assays. Analytical studies yielded a limit of detection of 2.4 IU/ml, with good linearity and correlation (R² = 0.9958) with expected HBV DNA titers over a wide range (6.0 x 10⁰ to 2.1 x 10⁸ IU/ml). Clinical sensitivity and specificity of the assay combined with automated sample processing were both 100%. Comparison of TaqMan HBV ASR and VERSANT HBV DNA 3.0 assay (bDNA; Bayer HealthCare LLC, Tarrytown, NY) results among clinical specimens yielded good correlation (R² = 0.9237), with a mean difference in titer of –0.213 log₁₀ IU/ml (95% confidence interval, –0.678 to 1.10 log₁₀ IU/ml). The overall test failure rate was 2.0% among 204 clinical serum specimens tested. Total time required for MP sample processing and automated postelution handling of 24 samples was 224 min, with 57 min of actual hands-on time. MP is a reliable, labor-saving platform suitable for use with TaqMan HBV ASR, providing sensitive and accurate quantification of HBV DNA levels over a range of 8 log₁₀ IU/ml.

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* Corresponding author. Mailing address: Division of Clinical Microbiology, Mayo Clinic, 200 First Street SW, Rochester, MN 55905. Phone: (507) 284-2255. Fax: (507) 284-4272. E-mail: jdcyao{at}mayo.edu.

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Journal of Clinical Microbiology, April 2006, p. 1490-1494, Vol. 44, No. 4
0095-1137/06/$08.00+0     doi:10.1128/JCM.44.4.1490-1494.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

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