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Journal of Clinical Microbiology, April 1998, p. 862-865, Vol. 36, No. 4
0095-1137/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.

Multicenter Evaluation of the COBAS AMPLICOR HCV Assay, an Integrated PCR System for Rapid Detection of Hepatitis C Virus RNA in the Diagnostic Laboratory

J. Albadalejo,1 R. Alonso,1 R. Antinozzi,2 M. Bogard,3 A.-M. Bourgault,4 G. Colucci,5,* T. Fenner,6 H. Petersen,6 E. Sala,2 J. Vincelette,4 and C. Young7

Servicio de Microbiologia Clinica y Enfermedades Infecciosas, Hospital General Universitario Gregorio Maranon, Madrid, Spain1; Laboratorio di Patologia Clinica, Ospedale S. Anna, Como, Italy2; Laboratoire de Biologie Moleculaire, Hopital de Meaux, Meaux, France3; PCR Unit, Roche Diagnostic Systems, Basel, Switzerland5; PCR Labor, Gemeinschaftspraxis Dres Fenner, Hamburg, Germany6; Hopital St. Luc, Montreal, Quebec, Canada4; and Roche Molecular Systems, Somerville, New Jersey7

Received 8 September 1997/Returned for modification 19 November 1997/Accepted 6 January 1998

The benefits shown by the recent introduction of PCR for the in vitro diagnosis of hepatitis C virus (HCV) infection has prompted the development of standardized, ready-to-use assays that can be implemented in routine clinical laboratories. We have evaluated the clinical performance of COBAS AMPLICOR HCV (COBAS), the first instrument system that allows the automation of HCV RNA amplification and detection, to determine its performance in the routine laboratory setting. More than 2,000 specimens collected at five centers were analyzed in parallel by the COBAS and the manual AMPLICOR HCV (AMPLICOR) tests, and the results were compared with the results for biochemical and serological markers of HCV. In this study the two PCR systems showed the same accuracy, with a concordance rate of 99.8%. As expected, the correlation between serology and PCR was not absolute because the presence of anti-HCV antibodies may be associated with a latent or past infection. On the other hand, if the presence of confirmed anti-HCV antibodies and elevated alanine aminotransferase levels are taken as the "gold standard," indicating an active, ongoing infection, the COBAS and AMPLICOR tests show high and comparable sensitivities (100%) and specificities (98%), with positive and negative predictive values of 100 and 97%, respectively. During the study no false-positive reactions were detected. The use of an internal control allowed the identification of inhibitory substances that prevented amplification for 0.3 and 0.4% of samples tested by the COBAS and AMPLICOR tests, respectively. Compared to the manual system, the COBAS system allowed a significant reduction of hands-on time and could improve the overall laboratory work flow. In conclusion, these results support the use of the COBAS and AMPLICOR tests for the molecular diagnosis of active HCV infections.

* Corresponding author. Mailing address: Roche Diagnostic Systems, Bldg. 222/121, 4070 Basel, Switzerland. Phone: 41 61 6873363. Fax: 41 61 6872109. E-mail: Giuseppe.Colucci.GC1{at}Roche.com.

Journal of Clinical Microbiology, April 1998, p. 862-865, Vol. 36, No. 4
0095-1137/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.


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