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Journal of Clinical Microbiology, November 2001, p. 4005-4012, Vol. 39, No. 11
0095-1137/01/$04.00+0   DOI: 10.1128/JCM.39.11.4005-4012.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.

Prospective Multicenter Clinical Evaluation of AMPLICOR and COBAS AMPLICOR Hepatitis C Virus Tests

Frederick S. Nolte,1,* Michael W. Fried,2 Mitchell L. Shiffman,3 Andrea Ferreira-Gonzalez,4 Carlton T. Garrett,4 Eugene R. Schiff,5 Stephen J. Polyak,6 and David R. Gretch6

Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, Georgia1; Division of Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina2; Hepatology Section3 and Department of Pathology,4 Medical College of Virginia Commonwealth University, Richmond, Virginia; Division of Hepatology, University of Miami School of Medicine, Miami, Florida5; and Department of Laboratory Medicine, University of Washington School of Medicine, Seattle, Washington6

Received 6 April 2001/Returned for modification 14 August 2001/Accepted 2 September 2001

We conducted a multicenter clinical evaluation of the second versions of the manual AMPLICOR and the semiautomated COBAS AMPLICOR tests for hepatitis C virus (HCV) RNA (Roche Molecular Systems, Inc., Pleasanton, Calif.). The performance characteristics of these HCV RNA tests for diagnosis of active viral infection were determined by comparison to anti-HCV serological test results, alanine aminotransferase levels, and liver biopsy histology results. A total of 878 patients with clinical or biochemical evidence of liver disease were enrolled at four hepatology clinics. A total of 1,089 specimens (901 serum and 188 plasma) were tested with the AMPLICOR test. Sensitivity compared to serology was 93.1% for serum and 90.6% for plasma. The specificity was 97% for serum and 93.1% for plasma. A total of 1,084 specimens (896 serum and 188 plasma) were tested with the COBAS test. Sensitivities for serum and plasma were the same as with the AMPLICOR test. The specificity was 97.8% for serum and 96.6% for plasma. Of the 69 specimens with false-positive and false-negative AMPLICOR test results relative to those of serology, alternative primer set (APS) reverse transcription (RT)-PCR analysis showed that the AMPLICOR test provided the correct result relative to the specimens containing HCV RNA in 64 (92.7%) specimens. Similarly, 66 of 67 (98.5%) false-positive and false-negative COBAS test results were determined to be correct by APS RT-PCR analysis. There were no substantive differences in clinical performances between study sites, patient groups, specimen types, storage conditions (-20 to -80°C versus 2 to 8°C), or anticoagulants (EDTA versus acid citrate dextrose) for either test. Both tests showed >99% reproducibility within runs, within sites, and overall. We conclude that these tests can reliably detect the presence of HCV RNA, as evidence of active infection, in patients with clinical or biochemical evidence of liver disease.

* Corresponding author. Mailing address: Emory University Hospital, Clinical Laboratories, 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, November 2001, p. 4005-4012, Vol. 39, No. 11
0095-1137/01/$04.00+0   DOI: 10.1128/JCM.39.11.4005-4012.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.


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