Ann Lab Med 2018; 38(6): 578-584  https://doi.org/10.3343/alm.2018.38.6.578
Development of a Rapid Automated Fluorescent Lateral Flow Immunoassay to Detect Hepatitis B Surface Antigen (HBsAg), Antibody to HBsAg, and Antibody to Hepatitis C
Ji Hyeong Ryu, B.S.1,2, Minsuk Kwon, Ph.D.3, Joung-Dae Moon, Ph.D.3, Min-Woong Hwang, M.S.3, Jeong-Min Lee, M.S.3, Ki-Hyun Park, M.S.1, So Jeong Yun, B.S.1, Hyun Jin Bae, B.S.1, Aeran Choi, B.S.2, Hyeyoung Lee, B.S.2,4, Bongsu Jung, Ph.D.5, Juhee Jeong, M.S.5, Kyungja Han, M.D., Ph.D.2, Yonggoo Kim, M.D., Ph.D.2, and Eun-Jee Oh, M.D., Ph.D.2
1Department of Molecular & Cell Biology, Graduate School, The Catholic University of Korea, Seoul, Korea; 2Department of Laboratory Medicine, College of Medicine, Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul, Korea; 3Central Lab, R&D Center, Boditech Med, Chungcheon, Korea; 4Department of Laboratory Medicine, International St. Mary’s Hospital, College of Medicine, Catholic Kwandong University, Incheon, Korea; 5Department of Biomedical Science, Daegu-Gyeongbuk Medical Innovation Foundation, Daegu, Korea
Corresponding author: Eun-Jee Oh
https://orcid.org/0000-0001-5870-915X
Department of Laboratory Medicine, College of Medicine, Seoul St. Mary’s Hospital, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul 06591, Korea
Tel: +82-2-2258-1641
Fax: +82-2-2258-1719
E-mail: ejoh@catholic.ac.kr
Co-corresponding author: Yonggoo Kim
https://orcid.org/0000-0003-2808-3795
Department of Laboratory Medicine, College of Medicine, Seoul St. Mary’s Hospital, The Catholic University of Korea 222 Banpo-daero, Seocho-gu, Seoul 06591, Korea
Tel: +82-2-2258-1642
Fax: +82-2-2258-1719
E-mail: yonggoo@catholic.ac.kr
Received: October 26, 2017; Revised: March 15, 2018; Accepted: July 4, 2018; Published online: November 1, 2018.
© Korean Society for Laboratory Medicine. All rights reserved.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Background: Accurate, rapid, and cost-effective screening tests for hepatitis B virus (HBV) and hepatitis C virus (HCV) infection may be useful in laboratories that cannot afford automated chemiluminescent immunoassays (CLIAs). We evaluated the diagnostic performance of a novel rapid automated fluorescent lateral flow immunoassay (LFIA).
Methods: A fluorescent LFIA using a small bench-top fluorescence reader, Automated Fluorescent Immunoassay System (AFIAS; Boditech Med Inc., Chuncheon, Korea), was developed for qualitative detection of hepatitis B surface antigen (HBsAg), antibody to HBsAg (anti-HBs), and antibody to HCV (anti-HCV) within 20 minutes. We compared the diagnostic performance of AFIAS with that of automated CLIAs—Elecsys (Roche Diagnostics GmbH, Penzberg, Germany) and ARCHITECT (Abbott Laboratories, Abbott Park, IL, USA)—using 20 seroconversion panels and 3,500 clinical serum samples.
Results: Evaluation with the seroconversion panels demonstrated that AFIAS had adequate sensitivity for HBsAg and anti-HCV detection. From the clinical samples, AFIAS sensitivity and specificity were 99.8% and 99.3% for the HBsAg test, 100.0% and 100.0% for the anti-HBs test, and 98.8% and 99.1% for the anti-HCV test, respectively. Its agreement rates with the Elecsys HBsAg, anti-HBs, and anti-HCV detection assays were 99.4%, 100.0%, and 99.0%, respectively. AFIAS detected all samples with HBsAg genotypes A-F and H and anti-HCV genotypes 1, 1a, 1b, 2a, 2b, 4, and 6. Cross-reactivity with other infections was not observed.
Conclusions: The AFIAS HBsAg, anti-HBs, and anti-HCV tests demonstrated diagnostic performance equivalent to current automated CLIAs. AFIAS could be used for a large-scale HBV or HCV screening in low-resource laboratories or low-to middle-income areas.
Keywords: HBsAg, Anti-HBs, Anti-HCV, Lateral flow immunoassay, Diagnostic performance



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