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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

Authors :
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
Source :
Kaohsiung Journal of Medical Sciences, Vol 23, Iss 7, Pp 332-338 (2007)
Publication Year :
2007
Publisher :
Wiley, 2007.

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.

Details

Language :
English
ISSN :
1607551X
Volume :
23
Issue :
7
Database :
Directory of Open Access Journals
Journal :
Kaohsiung Journal of Medical Sciences
Publication Type :
Academic Journal
Accession number :
edsdoj.6b6993517e8946d78c514111cbe75af3
Document Type :
article
Full Text :
https://doi.org/10.1016/S1607-551X(09)70418-8