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Journal of Clinical Microbiology, May 2006, p. 1726-1732, Vol. 44, No. 5
0095-1137/06/$08.00+0     doi:10.1128/JCM.44.5.1726-1732.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

Multilaboratory Comparison of Hepatitis C Virus Viral Load Assays

A. M. Caliendo,1* A. Valsamakis,2 Y. Zhou,3 B. Yen-Lieberman,4 J. Andersen,3 S. Young,5 A. Ferreira-Gonzalez,6 G. J. Tsongalis,7 R. Pyles,8 J. W. Bremer,9 and N. S. Lurain9

Emory University School of Medicine, Atlanta, Georgia,1 The Johns Hopkins Medical Institutions, Baltimore, Maryland,2 Harvard School of Public Health, Boston, Massachusetts,3 Cleveland Clinic Foundation, Cleveland, Ohio,4 Tricore Reference Laboratories, Albuquerque, New Mexico,5 Virginia Commonwealth University, Richmond, Virginia,6 Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire,7 University of Texas Medical Branch, Galveston, Texas,8 Division of AIDS Viral Quality Assurance Laboratory Viral Quality Assessment Laboratory, Rush University Medical Center, Chicago, Illinois9

Received 21 December 2005/ Returned for modification 31 January 2006/ Accepted 8 March 2006

We report a multilaboratory evaluation of hepatitis C virus (HCV) viral load assays to determine their linear range, reproducibility, subtype detection, and agreement. A panel of HCV RNA samples ranging in nominal concentration from 1.0 to 7.0 log10 IU/ml was constructed by diluting a clinical specimen (genotype 1b). Replicates of the panel were tested in multiple laboratories using the Abbott TaqMan analyte-specific reagent (Abbott reverse transcription-PCR [RT-PCR]), Roche TaqMan RUO (Roche RT-PCR), Roche Amplicor Monitor HCV 2.0 (Roche Monitor), and Bayer VERSANT HCV RNA 3.0 (Bayer bDNA) assays. Bayer bDNA-negative specimens were tested reflexively using the Bayer VERSANT HCV RNA qualitative assay (Bayer TMA). Abbott RT-PCR and Roche RT-PCR detected all 28 replicates with a concentration of 1.0 log10 IU/ml and were linear to 7.0 log10 IU/ml. Roche Monitor and Bayer bDNA detected 27 out of 28 and 13 out of 28 replicates, respectively, of 3.0 log10 IU/ml. Bayer TMA detected all seven replicates with 1.0 log10 IU/ml. Bayer bDNA was the most reproducible of the four assays. The mean viral load values for panel members in the linear ranges of the assays were within 0.5 log10 for the different tests. Eighty-nine clinical specimens of various genotypes (1 through 4) were tested in the Bayer bDNA, Abbott RT-PCR, and Roche RT-PCR assays. For Abbott RT-PCR, mean viral load values were 0.61 to 0.96 log10 greater than the values for Bayer bDNA assay for samples with genotype 1, 2, or 3 samples and 0.08 log10 greater for genotype 4 specimens. The Roche RT-PCR assay gave mean viral load values that were 0.28 to 0.82 log10 greater than those obtained with the Bayer bDNA assay for genotype 1, 2, and 3 samples. However, for genotype 4 samples the mean viral load value obtained with the Roche RT-PCR assay was, on average, 0.15 log10 lower than that of the Bayer bDNA. Based on these data, we conclude that the sensitivity and linear range of the Abbott and Roche RT-PCR assays enable them to be used for HCV diagnostics and therapeutic monitoring. However, the differences in the viral load values obtained with the different assays underscore the importance of using one assay when monitoring response to therapy.

* Corresponding author. Mailing address: Clinical Laboratories, H180, Emory University Hospital, 1364 Clifton Rd., Atlanta, GA 30322. Phone: (404) 712-5721. Fax: (404) 727-3133. E-mail: acalien{at}emory.edu.

Journal of Clinical Microbiology, May 2006, p. 1726-1732, Vol. 44, No. 5
0095-1137/06/$08.00+0     doi:10.1128/JCM.44.5.1726-1732.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.



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