Development of a Rapid Automated Fluorescent Lateral Flow Immunoassay to Detect Hepatitis B Surface Antigen (HBsAg), Antibody to HBsAg, and Antibody to Hepatitis C.
10.3343/alm.2018.38.6.578
- Author:
Ji Hyeong RYU
1
;
Minsuk KWON
;
Joung Dae MOON
;
Min Woong HWANG
;
Jeong Min LEE
;
Ki Hyun PARK
;
So Jeong YUN
;
Hyun Jin BAE
;
Aeran CHOI
;
Hyeyoung LEE
;
Bongsu JUNG
;
Juhee JEONG
;
Kyungja HAN
;
Yonggoo KIM
;
Eun Jee OH
Author Information
1. Department of Molecular & Cell Biology, Graduate School, The Catholic University of Korea, Seoul, Korea.
- Publication Type:Original Article
- Keywords:
HBsAg;
Anti-HBs;
Anti-HCV;
Lateral flow immunoassay;
Diagnostic performance
- MeSH:
Fluorescence;
Gangwon-do;
Genotype;
Hepacivirus;
Hepatitis B Surface Antigens*;
Hepatitis B virus;
Hepatitis B*;
Hepatitis C*;
Hepatitis*;
Immunoassay*;
Mass Screening;
Sensitivity and Specificity;
Seroconversion
- From:Annals of Laboratory Medicine
2018;38(6):578-584
- CountryRepublic of Korea
- Language:English
-
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.
