Annals of Laboratory Medicine

Korean Society for Laboratory Medicine (대한진단검사의학회)
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Development of a Rapid Automated Fluorescent Lateral Flow Immunoassay to Detect Hepatitis B Surface Antigen (HBsAg), Antibody to HBsAg, and Antibody to Hepatitis C

  • Ryu, Ji Hyeong (Department of Molecular & Cell Biology, Graduate School, The Catholic University of Korea) ;
  • Kwon, Minsuk (Central Lab, R&D Center, Boditech Med) ;
  • Moon, Joung-Dae (Central Lab, R&D Center, Boditech Med) ;
  • Hwang, Min-Woong (Central Lab, R&D Center, Boditech Med) ;
  • Lee, Jeong-Min (Central Lab, R&D Center, Boditech Med) ;
  • Park, Ki-Hyun (Department of Molecular & Cell Biology, Graduate School, The Catholic University of Korea) ;
  • Yun, So Jeong (Department of Molecular & Cell Biology, Graduate School, The Catholic University of Korea) ;
  • Bae, Hyun Jin (Department of Molecular & Cell Biology, Graduate School, The Catholic University of Korea) ;
  • Choi, Aeran (Department of Laboratory Medicine, College of Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea) ;
  • Lee, Hyeyoung (Department of Laboratory Medicine, College of Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea) ;
  • Jung, Bongsu (Department of Biomedical Science, Daegu-Gyeongbuk Medical Innovation Foundation) ;
  • Jeong, Juhee (Department of Biomedical Science, Daegu-Gyeongbuk Medical Innovation Foundation) ;
  • Han, Kyungja (Department of Laboratory Medicine, College of Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea) ;
  • Kim, Yonggoo (Department of Laboratory Medicine, College of Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea) ;
  • Oh, Eun-Jee (Department of Laboratory Medicine, College of Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea)
  • Received : 2017.10.26
  • Accepted : 2018.07.04
  • Published : 2018.11.01
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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

Acknowledgement

Grant : Development of Highly-Specialized Platform for IVD Medical Devices

Supported by : Ministry of Trade, Industry & Energy (MI)

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