Quantification of hepatitis C virus RNA in serum by branched DNA-based signal amplification assays

• Published in: Journal of virological methods 1999-05, Vol.79 (2), p.227-235
• Main Authors: Pawlotsky, Jean-Michel, Martinot-Peignoux, Michèle, Poveda, Jean-Dominique, Bastie, Anne, Le Breton, Véronique, Darthuy, Françoise, Rémiré, Jocelyne, Erlinger, Serge, Dhumeaux, Daniel, Marcellin, Patrick
• Format: Article
• Language: English
• Subjects: Biological and medical sciences; Branched DNA assays; DNA, Viral; Fundamental and applied biological sciences. Psychology; Genotype; Hepacivirus - genetics; Hepatitis C virus; Hepatitis C, Chronic - blood; Hepatitis C, Chronic - virology; Humans; Microbiology; Nucleic Acid Amplification Techniques; Reagent Kits, Diagnostic; RNA, Viral - blood; Sensitivity and Specificity; Techniques used in virology; Viral load; Virology
• ISSN: 0166-0934; 1879-0984
• DOI: 10.1016/S0166-0934(99)00024-5

The objective of the study was to compare the clinical sensitivity and specificity of versions 1.0 and 2.0 of the branched DNA (bDNA)-based hepatitis C virus (HCV) RNA quantification assay, and also to compare the values yielded by the two versions according to the HCV genotype. Serum samples from 268 patients tested routinely by a non-quantitative HCV RNA PCR assay (group A) were tested with version 2.0 of the bDNA assay. Samples from 342 HCV PCR-positive patients with chronic hepatitis C eligible for interferon treatment (group B) were tested with both version 1.0 and version 2.0 of the bDNA assay. Version 2.0 had a clinical sensitivity of 92% (95% confidence interval (CI): 87–97%) in group A and 89% (86–92%) in group B. In group B, the gain in sensitivity with bDNA 2.0 was 16% relative to bDNA 1.0 ( P