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ORIGINAL RESEARCH article
Front. Med.
Sec. Infectious Diseases: Pathogenesis and Therapy
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1536380
Evaluation of the HCV E2 Antigen EIA Test in HCV-Positive Samples with Diverse Backgrounds
Provisionally accepted- 1Department of Virology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
- 2Research Center for Clinical Virology, Tehran University of Medical Sciences, Tehran, Iran
- 3Middle East Liver Diseases (MELD) Center, Tehran, Iran
- 4Baqiyatallah Research Center for Gastroenterology and Liver Diseases (BRCGL), Clinical Sciences Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran
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The Hepatitis C virus is among the most critical viruses transmitted from the bloodstream and is responsible for cirrhosis and liver cancer in many patients. This study evaluated the efficiency of the HCV E2 antigen EIA test in detecting HCV across various clinical conditions. The test focuses on the E2 envelope protein, which can be detected without pre-treatment. A sandwich ELISA was used to enhance sensitivity, employing biotinylated secondary antibodies for signal amplification.Material and Methods: Serum samples came from 41 HCV-positive and 40 HCV-negative patients at the Iran Blood Transfusion Organization (IBTO). HCV status was confirmed using NAT and reevaluated with qPCR. The study used capture monoclonal antibodies against HCV E2 and detection antibodies, biotin-NHS, and streptavidin-HRP. The ELISA involved coating with anti-E2 antibodies, sample incubation, and detection with TMB. Accuracy, sensitivity, and specificity were analyzed using Medcalc and SPSS v21.Results: The HCV E2 ELISA test demonstrated an overall sensitivity of 88.9%, specificity of 91.3%, and accuracy of 90.2%. For healthy blood donors, sensitivity, specificity, and accuracy were 100%. Variability in test performance was observed among different patient groups, including false positives and negatives in specific cases. Conclusion: This study demonstrated HCV E2 antigen EIA test with significant sensitivity and specificity. Its performance is generally authentic but requires for careful interpretation in different clinical conditions. This method is valuable for diagnosing HCV and monitoring treatment progress.
Keywords: HCV1, E2 antigen2, ELISA3, Sensitivity and specificity4, diagnostic accuracy5
Received: 28 Nov 2024; Accepted: 09 Apr 2025.
Copyright: © 2025 Norouzi, Kargar Kheirabad, Alavian and Abyazi. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Mehdi Norouzi, Department of Virology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
Mohammad Ali Abyazi, Baqiyatallah Research Center for Gastroenterology and Liver Diseases (BRCGL), Clinical Sciences Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.