Basic Study
Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Hepatol. May 27, 2019; 11(5): 442-449
Published online May 27, 2019. doi: 10.4254/wjh.v11.i5.442
Hepatitis C virus antigens enzyme immunoassay for one-step diagnosis of hepatitis C virus coinfection in human immunodeficiency virus infected individuals
Ke-Qin Hu, Wei Cui, Susan D Rouster, Kenneth E Sherman
Ke-Qin Hu, Wei Cui, Division of GI/Hepatology, University of California, Irvine, School of Medicine, Orange, CA 92868, United States
Susan D Rouster, Kenneth E Sherman, Division of Digestive Diseases, University of Cincinnati College of Medicine, Cincinnati, OH 45267, United States
Author contributions: Hu KQ contributed to the study design, data collection and analysis, and writing and editing of the manuscript; Cui W contributed to experiment performance, data collection and analysis, and preparing the manuscript; Rouster S and Sherman K contributed to serum samples, data analysis, and preparing the manuscript.
Institutional review board statement: This research project has been approved by the University of California, Irvine, and University of Cincinnati College of Medicine Institutional Review Board.
Conflict-of-interest statement: All authors have no conflicts of interest related to this study.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Ke-Qin Hu, MD, FAASLD, Division of GI/Hepatology, University of California, Irvine, School of Medicine, 101 The City Drive, Building 56, Ste. 801, Orange, CA 92868, United States. kqhu@uci.edu
Telephone: +1-714-4566926 Fax: +1-714-4563283
Received: January 14, 2019
Peer-review started: February 13, 2019
First decision: March 8, 2019
Revised: May 8, 2019
Accepted: May 21, 2019
Article in press: May 21, 2019
Published online: May 27, 2019
Processing time: 103 Days and 3.9 Hours
Abstract
BACKGROUND

Current diagnosis of hepatitis C virus (HCV) infection requires two sequential steps: testing for anti-HCV followed by HCV RNA PCR to confirm viremia. We have developed a highly sensitive and specific HCV-antigens enzyme immunoassay (HCV-Ags EIA) for one-step diagnosis of viremic HCV infection.

AIM

To assess the clinical application of the HCV-Ags EIA in one-step diagnosis of viremic HCV infection in human immunodeficiency virus (HIV)-coinfected individuals.

METHODS

The study blindly tested HCV-Ags EIA for its performance in one-step diagnosing viremic HCV infection in 147 sera: 10 without HCV or HIV infection; 54 with viremic HCV monoinfection; 38 with viremic HCV/HIV coinfection; and 45 with viremic HCV and non-viremic HIV coinfection.

RESULTS

Upon decoding, it was 100% accordance of HCV-Ags EIA to HCV infection status by HCV RNA PCR test. In five sera with HCV infection, HCV RNA was as low as 50-59 IU/mL, and four out of five tested positive for HCV-Ags EIA. Likewise, it was also 100% accordance of HCV-Ags EIA to HCV infection status by HCV RNA PCR in 83 sera with HCV and HIV coinfection, regardless if HIV infection was active or not.

CONCLUSION

The modified HCV-Ags EIA has a lower detection limit equivalent to serum HCV RNA levels of approximately 100 IU/mL. It is highly sensitive and specific in the setting of HIV coinfection, regardless of HIV infection status and CD4 count. These data support the clinical application of the HCV-Ags EIA in one-step diagnosis of HCV infection in HIV-infected individuals.

Keywords: Hepatitis C virus; Hepatitis C virus antigens; Hepatitis C virus core antigen; Hepatitis C virus diagnostic test; Diagnostic assay; Enzyme immunoassay

Core tip: We recently developed a novel and highly sensitive and specific hepatitis C virus antigens (HCV-Ags) enzyme immunoassay for one-step diagnosis of viremic HCV infection. The present study blindly tested this test’s performance in 147 sera: 10 without HCV or human immunodeficiency virus (HIV) infection; 54 with viremic HCV monoinfection; 38 with viremic HCV/HIV coinfection; and 45 with viremic HCV and non-viremic HIV coinfection. Our results demonstrated that the HCV-Ags enzyme immunoassay is highly sensitive and specific in the setting of HIV coinfection, regardless of HIV infection status and CD4 count. These data support the clinical application of the HCV-Ags test in one-step diagnosis of HCV infection in HIV-infected individuals.