Multilaboratory evaluation of real-time PCR tests for hepatitis B virus DNA quantification

Angela M. Caliendo, Alexander Valsamakis, James W. Bremer, Andrea Ferreira-Gonzalez, Suzanne Granger, Linda Sabatini, Gregory J. Tsongalis, Yun F. Wang, Belinda Yen-Lieberman, Steve Young, Nell S. Lurain

Research output: Contribution to journalArticlepeer-review


The performance characteristics of four different assays for hepatitis B virus (HBV) quantification were assessed: the Abbott RealTime HBV IUO, the Roche Cobas AmpliPrep/Cobas TaqMan HBV test, the Roche Cobas TaqMan HBV test with HighPure system, and the Qiagen artus HBV TM ASR. Limit of detection (LOD), linear range, reproducibility, and agreement were determined using a serially diluted plasma sample from a single chronically infected subject. Each assay was tested by at least three laboratories. The LOD of the RealTime and two TaqMan assays was approximately 1.0 log 10 IU/ml; for artus HBV (which used the lowest volume of extracted DNA), it was approximately 1.5 log 10 IU/ml. The linear range spanned 1.0 to at least 7.0 log 10 IU/ml for all assays. Median values were consistently lowest for artus HBV and highest for Cobas AmpliPrep/Cobas TaqMan HBV. Assays incorporating automated nucleic acid extraction were the most reproducible; however, the overall variability was minor since the standard deviations for the means of all tested concentrations were ≤0.32 log 10 IU/ml for all assays. False-positive results were observed with all assays; the highest rates occurred with tests using manual nucleic acid extraction. The performance characteristics of these assays suggest that they are useful for management and therapeutic monitoring of chronic HBV infection.

Original languageEnglish (US)
Pages (from-to)2854-2858
Number of pages5
JournalJournal of clinical microbiology
Issue number8
StatePublished - Aug 2011

ASJC Scopus subject areas

  • Microbiology (medical)

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