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Journal of Clinical Microbiology, May 2005, p. 2477-2480, Vol. 43, No. 5
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.5.2477-2480.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

Efficiency of the Ortho VITROS Assay for Detection of Hepatitis C Virus-Specific Antibodies Increased by Elimination of Supplemental Testing of Samples with Very Low Sample-to-Cutoff Ratios

Margret Oethinger,2 Donald R. Mayo,1,2 JoAnne Falcone,1 Pankaj K. Barua,1 and Brigitte P. Griffith1,2*

Virology Reference and Molecular Diagnostic Laboratories, VA CT Healthcare System, West Haven, Connecticut,1 Department of Laboratory Medicine, Yale University School of Medicine, New Haven, Connecticut2

Received 30 September 2004/ Returned for modification 13 December 2004/ Accepted 7 January 2005

The clinical significance of specimens with low sample-to-cutoff (S/Co) ratios in the Ortho VITROS chemiluminescence assay (CIA) for detection of antibodies to hepatitis C virus (HCV) was evaluated. In one study of 482 CIA-reactive samples, none of the 83 samples with S/Co ratios of <5 was HCV RNA positive. In a subsequent study, 332 samples with S/Co ratios of between 1 and 20 were tested with the recombinant immunoblot assay (RIBA). None of the 163 samples with S/Co ratios of <5 was RIBA positive, 83% were RIBA negative, and 28 samples (18%) were RIBA indeterminate. HCV RNA and/or clinical evidence of hepatitis was not found in the 27 indeterminate cases examined. These results show that over 99% of samples with very low S/Co ratios (≤5) have no evidence of HCV infection. Therefore, we suggest that the HCV antibody testing algorithm for the VITROS assay might be modified to eliminate supplemental testing of samples with very low S/Co ratios.

* Corresponding author. Mailing address: Virology Reference Laboratory, VA Connecticut Healthcare System, 950 Campbell Avenue, West Haven, CT 06516. Phone: (203) 932-5711, ext. 3504. Fax: (203) 937-3893. E-mail: brigitte.griffith{at}yale.edu.

Journal of Clinical Microbiology, May 2005, p. 2477-2480, Vol. 43, No. 5
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.5.2477-2480.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.



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