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Journal of Clinical Microbiology, August 2004, p. 3739-3746, Vol. 42, No. 8
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.8.3739-3746.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

Performance Characteristics of a Quantitative TaqMan Hepatitis C Virus RNA Analyte-Specific Reagent

James M. Barbeau,1 Jennifer Goforth,2 Angela M. Caliendo,1 and Frederick S. Nolte1*

Department of Pathology and Laboratory Medicine, Emory University School of Medicine,1 Emory Medical Laboratories, Emory University Hospital, Atlanta, Georgia2

Received 12 February 2004/ Returned for modification 7 April 2004/ Accepted 7 May 2004

We determined the dynamic range, reproducibility, accuracy, genotype bias, and sensitivity of the TaqMan hepatitis C virus (HCV) analyte-specific reagent (ASR). Serum samples were processed using the MagNA Pure LC instrument and run on the COBAS TaqMan 48 analyzer. The performance characteristics of the ASR were also compared with those of the qualitative AMPLICOR and quantitative AMPLICOR MONITOR HCV tests. The ASR exhibited a ≥6-log10 linear dynamic range and excellent reproducibility, with a mean coefficient of variation of 14%. HCV RNA concentration measured with the ASR agreed within an average of 0.42 log10 (2.6-fold) of the labeled concentration with members of a standard reference panel. HCV genotypes 1 to 4 were amplified with similar efficiencies with the ASR. The ASR and AMPLICOR MONITOR viral load results were significantly correlated (r = 0.8898; P < 0.01), but the agreement was poor (mean difference, 0.45 ± 0.35 log10) for 72 HCV RNA-positive clinical samples. However, 98.9% agreement between the ASR and qualitative AMPLICOR test results was found with 60 positive and 29 negative samples. Limiting-dilution experiments demonstrated that the limits of detection for ASR and AMPLICOR tests were 84 and 26 IU/ml, respectively. The performance characteristics of the TaqMan HCV ASR are appropriate for all clinical applications of HCV RNA testing.

* Corresponding author. Mailing address: Emory University Hospital, Room F145, 1364 Clifton Rd. NE, Atlanta, GA 30322. Phone: (404) 712-7297. Fax: (404) 712-4632. E-mail: fnolte{at}emory.edu.

Journal of Clinical Microbiology, August 2004, p. 3739-3746, Vol. 42, No. 8
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.8.3739-3746.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.



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