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.
The Kaohsiung journal of medical sciences 2007 Jul 1; 23(7):332-8
Hsieh M MY, Lee L LP, Hou N NJ, Yang J JF, Huang J JF, Dai C CY, Chuang W WL,
Division of Hepatobiliary Medicine, Department of Internal Medicine, Kaohsiung Medical University Ho
The objective of this research was to investigate the clinical performance of COBAS AMPLICOR hepatitis C virus (HCV) test version 2.0 Assays (CAV2.0). 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 CAV2.0 (the limit of detection was 50 IU/mL). HCV RNA was investigated with CAV2.0 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 CAV2.0 and CAV1.0 at weeks 2, 4 and 8. The positive detection rates of CAV2.0 were significantly higher than CAV1.0 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 CAV2.0, and 90.24%, 82.14% and 72.73% with CAV1.0. The negative predictive values were 58.82%, 77.42% and 86.96% with CAV2.0, and 67.44%, 82.14% and 83.33% with CAV1.0. However, there was no significant difference between CAV2.0 and CAV1.0 for predicting sustained virologic response.