期刊
JOURNAL OF VIROLOGICAL METHODS
卷 162, 期 1-2, 页码 203-207出版社
ELSEVIER
DOI: 10.1016/j.jviromet.2009.08.008
关键词
Hepatitis C; Anti-HCV; Performance evaluation; Sensitivity; Specificity
资金
- Chinese Basic Research Foundation 973 [2005CB522902, 2007CB512900]
- 863 program [2006AA02A410]
- NSFC [30571639]
- National Science and Technology Key Project during the 11th Five-Year Plan Period [2008ZX70002-012, 2008ZX10002-013]
- Key Clinical Research Program of Ministry of Health
The EIAgen HCV test (Adaltis Inc., Montreal, Canada) is an enzyme immunoassay (EIA) for the detection of anti-hepatitis C virus (HCV) antibodies. This study compared the performance of this test side-by-side with the current Ortho HCV 3.0 Anti-HCV assay (Ortho-Clinical Diagnostics Inc., Johnson & Johnson Company, Raritan, NY, USA). Among 2559 specimens examined, 178 were true positives, 2376 were true negatives and 5 were indeterminate. The sensitivity of the EIAgen HCV test was 100%, versus 98.3% for the Ortho HCV test, while their respective specificities were 98.1% and 98.2%. The EIAgen HCV test gave a positive predictive value of 79.8% and a negative predictive value of 100%. Overall, the concordance of this test with the Ortho HCV test was 98.2%. Specimens from potentially interfering substances, such as sera from pregnant women, sera from patients with acute non-C hepatitis, autoimmune diseases, lipidemia, or from patients undergoing hemolysis, showed no interference with either EIA. An EIAgen HCV test signal-to-cut-off ratio of > 5.9 would be highly predictive of a true-positive finding in these specimens. The EIAgen HCV test is well suited for screening blood and blood products in antibodies to HCV. (c) 2009 Elsevier B.V. All rights reserved.
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