Comparison of HCV RNA assays for the detection and quantification of hepatitis C virus RNA levels in serum of patients with chronic hepatitis C treated with interferon

✍ Scribed by Trabaud, M.-A.; Bailly, F.; Si-Ahmed, S. N.; Chevallier, P.; Sepetjan, M.; Colucci, G.; Trépo, C.

• Publisher: John Wiley and Sons
• Year: 1997
• Tongue: English
• Weight: 214 KB
• Volume: 52
• Category: Article
• ISSN: 0146-6615
• DOI: 10.1002/(sici)1096-9071(199705)52:1<105::aid-jmv17>3.0.co;2-l

✦ Synopsis

Detection and quantification of hepatitis C virus (HCV) RNA levels by using the standardized qualitative Amplicor™ HCV and quantitative Amplicor HCV Monitor™ assays (Roche Molecular Systems) were evaluated in 48 patients with chronic hepatitis C treated with interferon. Results were compared with an in-house reverse transcription and polymerase chain reaction (RT-PCR) assay and the branched DNA (bDNA) assay (Quantiplex™, version 1.0, Chiron Diagnostics). Concordance of the qualitative results with the Amplicor™ HCV and in-house RT-PCR assays occurred in 82% of the samples. All but one of the discrepant specimens were found positive by the Amplicor™ HCV assay and negative by the in-house RT-PCR. Among the samples with HCV RNA levels measurable with the Amplicor HCV Monitor™ assay, 22% had HCV RNA titers below the detection limit of the Quantiplex™ assay. A statistically significant correlation was found between the 2 quantitative assays, although lower titers were obtained with the Amplicor HCV Monitor™ assay. More important, a good correlation was observed in the evolution of viremia as measured by the 2 assays during interferon therapy. During followup of interferon treatments, with the Amplicor HCV Monitor™ assay, persisting viremia was still detected in 27% of the patients who normalised alanine aminotransferase (ALT), emphasizing the bioclinical relevance of the assay. Pretreatment serum HCV RNA levels above 10 5 copies/ml were found more frequently in nonresponders than in responders (76% vs. 44%; P < 0.05). Given their great sensitivity and the significant correlations, the Amplicor™ HCV qualitative and quantitative assays appear useful for the diagnosis and management of hepa-titis C infection, and especially for monitoring of therapy.