Kaohsiung Journal of Medical Sciences (Jul 2007)

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

  • Ming-Yen Hsieh,
  • Li-Po Lee,
  • Nai-Jen Hou,
  • Jeng-Fu Yang,
  • Jee-Fu Huang,
  • Chia-Yen Dai,
  • Wan-Long Chuang,
  • Zu-Yau Lin,
  • Shinn-Cherng Chen,
  • Ming-Yuh Hsieh,
  • Liang-Yen Wang,
  • Wen-Yu Chang,
  • Ming-Lung Yu

DOI
https://doi.org/10.1016/S1607-551X(09)70418-8
Journal volume & issue
Vol. 23, no. 7
pp. 332 – 338

Abstract

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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.

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