新型自动化第三代抗丙型肝炎病毒酶免疫测定法的评估

Evaluation of a new automated third-generation anti-HCV enzyme immunoassay.

作者信息

Lavanchy D, Steinmann J, Möritz A, Frei P C

机构信息

Centre Hospitalier Universitaire Vaudois, Division d'Immunologie et Allergie, Lausanne, Switzerland.

出版信息

J Clin Lab Anal. 1996;10(5):269-76. doi: 10.1002/(SICI)1098-2825(1996)10:5<269::AID-JCLA7>3.0.CO;2-3.

DOI:10.1002/(SICI)1098-2825(1996)10:5<269::AID-JCLA7>3.0.CO;2-3

PMID:8887006

Abstract

The new Cobas Core Anti-HCV EIA was evaluated in two centers for its ability to detect antibodies directed to hepatitis C virus in human serum. This assay, which can be run fully automated on a random access analyzer, was compared with three other commercially available screening tests: the Ortho HCV 3.0 ELISA, the Murex anti-HCV, and the Abbott HCV EIA second generation. Positive or discrepant results were further investigated using the Wellcozyme HCV Western Blot or the Abbott Matrix HCV assays. The results obtained from analyzing 5045 serum samples showed a high correlation between the Cobas Core Anti-HCV EIA and the other screening assays, ranging from 98.9% to 99.9%. Diagnostic specificities and sensitivities ranged from 99.7% to 100% and from 98.8% to 100%, respectively. In this study, the Cobas Core Anti-HCV EIA proved to be a very convenient test, able to perform at the highest levels of sensitivity and specificity.

摘要

新型Cobas Core抗丙型肝炎病毒酶免疫测定法在两个中心进行了评估，以检测人血清中针对丙型肝炎病毒的抗体。该检测方法可在随机存取分析仪上完全自动化运行，并与其他三种市售筛查试验进行了比较：Ortho HCV 3.0酶联免疫吸附测定法、Murex抗丙型肝炎病毒检测法和雅培第二代丙型肝炎病毒酶免疫测定法。使用Wellcozyme HCV免疫印迹法或雅培Matrix HCV检测法对阳性或有差异的结果进行进一步研究。对5045份血清样本的分析结果显示，Cobas Core抗丙型肝炎病毒酶免疫测定法与其他筛查试验之间具有高度相关性，范围在98.9%至99.9%之间。诊断特异性和敏感性分别在99.7%至100%和98.8%至100%之间。在本研究中，Cobas Core抗丙型肝炎病毒酶免疫测定法被证明是一种非常便捷的检测方法，能够在最高水平的敏感性和特异性下进行检测。