title: [Clinical significance of Cobas Amplicor HCV Monitor test v 2.0 for quantifying a wide range of serum HCV-RNA in patients with chronic hepatitis C].
abstract: Recently, we evaluated the clinical significance of a new assay, the semi-automated Cobas Amplicor HCV Monitor test v 2.0 (Roche, Cobas-HIGH-RANGE assay), for quantifying serum hepatitis C virus RNA throughout a wider range than the traditional assay, Amplicor GT HCV Monitor test v 2.0 (GT-ORIGINAL assay). We compared the results of the Cobas-HIGH-RANGE assay with results of the GT-ORIGINAL assay. This study was conducted on serum from 91 patients with chronic hepatitis C at the Gastroenterological Center, Yokohama City University Medical Center. The percent coefficient of variation (CV) for the within-run and between-run reproducibility of the Cobas-HIGH-RANGE assay ranged from 0.7 to 2.3% and from 1.3 to 2.0%, respectively. The Cobas-HIGH-RANGE assay exhibited a linear range extending from 5 to 5000 KIU/ml. The values for all 17 samples determined as less than 0.5 KIU/ml by the GT-ORIGINAL assay were also determined as less than 5 KIU/ml by the Cobas-HIGH-RANGE assay. For the 48 samples with values of 0.5 to 850 KIU/ml determined by the GT-ORIGINAL assay, the values obtained by these two assay methods were significantly correlated (r2 = 0.9117, y = 1.0667x-0.0801, p < 0.001), but the values of HCV-RNA determined by the Cobas-HIGH-RANGE assay were significantly (p < 0.05) higher than those determined by the GT-ORIGINAL assay. Consequently, these data indicate that the HIGH-RANGE assay is a useful alternative assay method for measurement of HCV-RNA instead of the ORIGINAL assay, and that the HIGH-RANGE assay could be a useful tool for monitoring the efficacy of antiviral treatment.
authors.affiliation: Department of Laboratory Medicine and Clinical Investigation, Yokohama City University Medical Center, Yokohama 232-0024.
authors.forename: Yoshimi
authors.initials: Y
authors.lastname: Fukuno
authors.forename: Haruka
authors.initials: H
authors.lastname: Takeda
authors.forename: Akie
authors.initials: A
authors.lastname: Sugou
authors.forename: Katsuaki
authors.initials: K
authors.lastname: Tanaka
authors.forename: Eiji
authors.initials: E
authors.lastname: Miyajima
mesh_terms: D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood; D005260:Female; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000821:virology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods*; D012367:RNA, Viral / Q000097:blood*; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000379:methods*; D019562:Viral Load
chemical_list: D015415:Biomarkers; D012367:RNA, Viral