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Journal of Clinical Microbiology, September 2009, p. 2872-2878, Vol. 47, No. 9
0095-1137/09/$08.00+0     doi:10.1128/JCM.02329-08
Copyright © 2009, American Society for Microbiology. All Rights Reserved.

Evaluation of the Abbott Investigational Use Only RealTime Hepatitis C Virus (HCV) Assay and Comparison to the Roche TaqMan HCV Analyte-Specific Reagent Assay{triangledown}

Michael T. Pyne,1* Eric Q. Konnick,1,{dagger} Amit Phansalkar,1,{ddagger} and David R. Hillyard1,2

ARUP Institute for Clinical and Experimental Pathology, 500 Chipeta Way, Salt Lake City, Utah 84108,1 University of Utah Department of Pathology, 15 North Medical Drive East, Salt Lake City, Utah 841122

Received 3 December 2008/ Returned for modification 17 February 2009/ Accepted 14 July 2009

The accurate and sensitive measurement of hepatitis C virus (HCV) RNA is essential for the clinical management and treatment of infected patients and as a research tool for studying the biology of HCV infection. We evaluated the linearity, reproducibility, precision, limit of detection, and concordance of viral genotype quantitation of the Abbott investigational use only RealTime HCV (RealTime) assay using the Abbott m2000 platform and compared the results to those of the Roche TaqMan Analyte-Specific Reagent (TaqMan) and Bayer Versant HCV bDNA 3.0 assay. Comparison of 216 samples analyzed by RealTime and TaqMan assays produced the following Deming regression equation: RealTime = 0.940 (TaqMan) + 0.175 log10 HCV RNA IU/ml. The average difference between the assays was 0.143 log10 RNA IU/ml and was consistent across RealTime's dynamic range of nearly 7 log10 HCV RNA IU/ml. There was no significant difference between genotypes among these samples. The limit of detection using eight replicates of the World Health Organization HCV standard was determined to be 7.74 HCV RNA IU/ml by probit analysis. Replicate measurements of commercial genotype panels were significantly higher than TaqMan measurements for most samples and showed that the RealTime assay is able to detect all genotypes with no bias. Additionally, we showed that the amplicon generated by the widely used Roche COBAS Amplicor Hepatitis C Virus Test, version 2.0, can act as a template in the RealTime assay, but potential cross-contamination could be mitigated by treatment with uracil-N-glycosylase. In conclusion, the RealTime assay accurately measured HCV viral loads over a broad dynamic range, with no significant genotype bias.

* Corresponding author. Mailing address: ARUP Institute for Clinical and Experimental Pathology, 500 Chipeta Way, Salt Lake City, UT 84108. Phone: (801) 583-2787, ext. 3431. Fax: (801) 584-5048. E-mail: michael.pyne{at}aruplab.com

{triangledown} Published ahead of print on 22 July 2009.

{dagger} Present address: University of Utah School of Medicine, 30 N 1900 E, Salt Lake City, UT 84132.

{ddagger} Present address: Cytel Inc., 675 Massachusetts Ave., Cambridge, MA 02139.

Journal of Clinical Microbiology, September 2009, p. 2872-2878, Vol. 47, No. 9
0095-1137/09/$08.00+0     doi:10.1128/JCM.02329-08
Copyright © 2009, American Society for Microbiology. All Rights Reserved.





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