title: Qualitative application of COBAS AMPLICOR HCV test version 2.0 assays in patients with chronic hepatitis C virus infection and comparison of clinical performance with version 1.0.
abstract: The objective of this research was to investigate the clinical performance of COBAS AMPLICOR hepatitis C virus (HCV) test version 2.0 Assays (CA V2.0). Eight serial samples with standard HCV ribonucleic acid (RNA) concentration and 10 times serial dilution of the 500 IU/mL samples were tested in triplicate by CA V2.0 (the limit of detection was 50 IU/mL). HCV RNA was investigated with CA V2.0 in 220 specimens from 100 chronic hepatitis C (CHC) patients, 60 chronic hepatitis B patients, and 60 healthy blood donors. The sensitivity was 99% and the specificity was 98.3%. Sera of 84 naïve CHC patients receiving standard interferon plus ribavirin for 24 weeks were tested by CA V2.0 and CA V1.0 at weeks 2, 4 and 8. The positive detection rates of CA V2.0 were significantly higher than CA V1.0 at week 2 (60.7% vs. 51.2%; p < 0.01) and week 8 (27.4% vs. 21.4%; p < 0.05). At weeks 2, 4 and 8, the positive predictive values were 90.91%, 83.02% and 78.69% with CA V2.0, and 90.24%, 82.14% and 72.73% with CA V1.0. The negative predictive values were 58.82%, 77.42% and 86.96% with CA V2.0, and 67.44%, 82.14% and 83.33% with CA V1.0. However, there was no significant difference between CA V2.0 and CA V1.0 for predicting sustained virologic response.
authors.affiliation: Division of Hepatobiliary Medicine, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
authors.forename: Ming-Yen
authors.initials: MY
authors.lastname: Hsieh
authors.forename: Li-Po
authors.initials: LP
authors.lastname: Lee
authors.forename: Nai-Jen
authors.initials: NJ
authors.lastname: Hou
authors.forename: Jeng-Fu
authors.initials: JF
authors.lastname: Yang
authors.forename: Jee-Fu
authors.initials: JF
authors.lastname: Huang
authors.forename: Chia-Yen
authors.initials: CY
authors.lastname: Dai
authors.forename: Wan-Long
authors.initials: WL
authors.lastname: Chuang
authors.forename: Zu-Yau
authors.initials: ZY
authors.lastname: Lin
authors.forename: Shinn-Cherng
authors.initials: SC
authors.lastname: Chen
authors.forename: Ming-Yuh
authors.initials: MY
authors.lastname: Hsieh
authors.forename: Liang-Yen
authors.initials: LY
authors.lastname: Wang
authors.forename: Wen-Yu
authors.initials: WY
authors.lastname: Chang
authors.forename: Ming-Lung
authors.initials: ML
authors.lastname: Yu
mesh_terms: D019698:Hepatitis C, Chronic / Q000175:diagnosis* / Q000188:drug therapy; D006801:Humans; D007372:Interferons / Q000008:administration & dosage; D012367:RNA, Viral / Q000097:blood*; D015203:Reproducibility of Results; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012254:Ribavirin / Q000008:administration & dosage; D012680:Sensitivity and Specificity
chemical_list: D012367:RNA, Viral; D012254:Ribavirin; D007372:Interferons