1. 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
- Author
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Shinn-Cherng Chen, Wan-Long Chuang, Jee-Fu Huang, Jeng-Fu Yang, Zu-Yau Lin, Nai-Jen Hou, Ming-Yen Hsieh, Li-Po Lee, Ming-Yuh Hsieh, Ming-Lung Yu, Liang-Yen Wang, Chia-Yen Dai, and Wen-Yu Chang
- Subjects
hepatitis C virus ,medicine.medical_specialty ,Serial dilution ,Hepatitis C virus ,medicine.disease_cause ,Sensitivity and Specificity ,Gastroenterology ,Virus ,chemistry.chemical_compound ,Interferon ,Internal medicine ,Ribavirin ,Cobas amplicor ,medicine ,Humans ,Medicine(all) ,hepatitis C virus RNA ,lcsh:R5-920 ,Reverse Transcriptase Polymerase Chain Reaction ,business.industry ,Clinical performance ,Reproducibility of Results ,General Medicine ,Hepatitis C ,Hepatitis C, Chronic ,medicine.disease ,qualitative hepatitis C virus RNA assay ,Virology ,chemistry ,RNA, Viral ,interferon therapy ,Interferons ,lcsh:Medicine (General) ,business ,medicine.drug - 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.
- Published
- 2007
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