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Journal of Clinical Microbiology, February 2004, p. 563-569, Vol. 42, No. 2
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.2.563-569.2004
Copyright © 2004, American Society of Microbiology. All Rights Reserved.

Multicenter Evaluation of the Performance Characteristics of the Bayer VERSANT HCV RNA 3.0 Assay (bDNA)

Tarek Elbeik,^1,2* Johan Surtihadi,³ Mark Destree,^4, Jed Gorlin,⁴ Mark Holodniy,⁵ Saeed A. Jortani,⁶ Ken Kuramoto,^7, Valerie Ng,^1,2 Roland Valdes Jr.,⁶ Alexandra Valsamakis,⁸ and Norah A. Terrault⁹

Department of Laboratory Medicine,¹ Department of Medicine, Division of Gastroenterology, University of California, San Francisco,⁹ Clinical Laboratories at San Francisco General Hospital, San Francisco,² Department of Biostatistics, Diagnostics Division, Bayer Healthcare LLC, Berkeley,³ AIDS Research Center, Veterans Administration Palo Alto Health Care System and Division of Infectious Diseases and Geographic Medicine, Stanford University, Palo Alto ,⁵ BloodSource, Center for Blood Research, Sacramento, California,⁷ Memorial Blood Center of Minneapolis, Minneapolis, Minnesota,⁴ Department of Pathology and Laboratory Medicine, University of Louisville School of Medicine, Louisville, Kentucky,⁶ Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, Maryland⁸

Received 10 May 2003/ Returned for modification 18 July 2003/ Accepted 5 November 2003

In this multicenter evaluation, the VERSANT HCV RNA 3.0 Assay (bDNA) (Bayer Diagnostics, Tarrytown, N.Y.) was shown to have excellent reproducibility, linearity, and analytical sensitivity across specimen collection matrices (serum, EDTA, ACD-A), and hepatitis C virus (HCV) genotypes 1 to 6. The VERSANT HCV bDNA Assay has a reportable range of 615 to 7,690,000 (7.69 x 10⁶) IU/ml. The total coefficient of variation (CV) ranged from 32.4% at 615 IU/ml to 17% at 6.8 x 10⁶ IU/ml. The assay was linear across the reportable range. Analytical specificity of 98.8% was determined by testing 999 specimens from volunteer blood donors. Evaluation of HCV genotypes using RNA transcripts of representative clones of 1a, 1b, 2a, 2b, 2c, 3a, 4a, 5a, and 6a and patient specimens showed that the largest difference between genotype 1, upon which the assay is standardized, and non-1 genotypes was within 1.5-fold. Testing of potentially interfering endogenous substances and exogenous substances and conditions found no interference in HCV-positive or HCV-negative specimens except for unconjugated bilirubin at concentrations of 20 mg/dl and protein at concentrations of 9 g/dl. Biological variability was estimated from 29 clinically stable individuals not on HCV therapy who were tested weekly over an 8-week period. The combined estimate of total (biologic plus assay) variability was 0.15 log₁₀ standard deviation (CV, 36.1%), a fold change of 2.6. Thus, the observed fold change between any two consecutive HCV RNA measures is expected to be less than 2.6-fold (equivalent to 0.41 log₁₀ IU/ml) 95% of the time in clinically stable individuals.

Present address: Roche Diagnostics, Indianapolis, Indiana.

Present address: XDx Corporation, South San Francisco, California.

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