Annals of Laboratory Medicine

  • 제38권6호
  • /
  • Pages.578-584
  • /
  • 2018
  • /
  • 2234-3806(pISSN)
  • /
  • 2234-3814(eISSN)
대한진단검사의학회 (Korean Society for Laboratory Medicine)
권호 표지
DOI QR코드

DOI QR Code

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)
  • 투고 : 2017.10.26
  • 심사 : 2018.07.04
  • 발행 : 2018.11.01
⟨ 이전 논문 다음 논문 ⟩

초록

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.

키워드

과제정보

연구 과제번호 : Development of Highly-Specialized Platform for IVD Medical Devices

연구 과제 주관 기관 : Ministry of Trade, Industry & Energy (MI)

참고문헌

  1. Shivkumar S, Peeling R, Jafari Y, Joseph L, Pant Pai N. Accuracy of rapid and point-of-care screening tests for hepatitis C: a systematic review and meta-analysis. Ann Intern Med 2012;157:558-66. https://doi.org/10.7326/0003-4819-157-8-201210160-00006
  2. O'Connell RJ, Gates RG, Bautista CT, Imbach M, Eggleston JC, Beardsley SG, et al. Laboratory evaluation of rapid test kits to detect hepatitis C antibody for use in predonation screening in emergency settings. Transfusion 2013;53:505-17. https://doi.org/10.1111/j.1537-2995.2012.03770.x
  3. Njai HF, Shimakawa Y, Sanneh B, Ferguson L, Ndow G, Mendy M, et al. Validation of rapid point-of-care (POC) tests for detection of hepatitis B surface antigen in field and laboratory settings in the Gambia, Western Africa. J Clin Microbiol 2015;53:1156-63. https://doi.org/10.1128/JCM.02980-14
  4. Posthuma-Trumpie GA, Korf J, van Amerongen A. Lateral flow (immuno)assay: its strengths, weaknesses, opportunities and threats. A literature survey. Anal Bioanal Chem 2009;393:569-82. https://doi.org/10.1007/s00216-008-2287-2
  5. Xia X, Xu Y, Zhao X, Li Q. Lateral flow immunoassay using europium chelate-loaded silica nanoparticles as labels. Clin Chem 2009;55:179-82.
  6. Heiat M, Ranjbar R, Alavian SM. Classical and modern approaches used for viral hepatitis diagnosis. Hepat Mon 2014;14:e17632.
  7. Chevaliez S, Poiteau L, Rosa I, Soulier A, Roudot-Thoraval F, Laperche S, et al. Prospective assessment of rapid diagnostic tests for the detection of antibodies to hepatitis C virus, a tool for improving access to care. Clin Microbiol Infect 2016;22:459.e1-6. https://doi.org/10.1016/j.cmi.2016.01.009
  8. Poiteau L, Soulier A, Rosa I, Roudot-Thoraval F, Hezode C, Pawlotsky JM, et al. Performance of rapid diagnostic tests for the detection of antibodies to hepatitis C virus in whole blood collected on dried blood spots. J Viral Hepat 2016;23:399-401. https://doi.org/10.1111/jvh.12501
  9. Kim KR, Han YD, Chun HJ, Lee KW, Hong DK, Lee KN, et al. Encapsulation-stabilized, europium containing nanoparticle as a probe for time-resolved luminescence detection of cardiac troponin I. Biosensors (Basel) 2017;7:E48.
  10. Kim BC, Jeong JH, et al. Simplified laser fluorescence scanner for proteomics studies and early cancer diagnosis. In: Chance B, Chen M, et al. eds. Photonics Asia-Optics in health care and biomedical optics: diagnostics and treatment. Shanghai: SPIE, 2002:103-8.
  11. Koczula KM and Gallotta A. Lateral flow assays. Essays Biochem 2016; 60:111-20. https://doi.org/10.1042/EBC20150012
  12. Peeling RW and Mabey D. Point-of-care tests for diagnosing infections in the developing world. Clin Microbiol Infect 2010;16:1062-9. https://doi.org/10.1111/j.1469-0691.2010.03279.x
  13. Smith BD, Jewett A, Drobeniuc J, Kamili S. Rapid diagnostic HCV antibody assays. Antivir Ther 2012;17:1409-13. https://doi.org/10.3851/IMP2470
  14. Kim DS, Kim YT, Hong SB, Kim J, Huh NS, Lee MK, et al. Development of lateral flow assay based on size-controlled gold nanoparticles for detection of hepatitis B surface antigen. Sensors (Basel) 2016;16:2154. https://doi.org/10.3390/s16122154
  15. Scheiblauer H, El-Nageh M, Diaz S, Nick S, Zeichhardt H, Grunert HP, et al. Performance evaluation of 70 hepatitis B virus (HBV) surface antigen (HBsAg) assays from around the world by a geographically diverse panel with an array of HBV genotypes and HBsAg subtypes. Vox Sang 2010;98:403-14. https://doi.org/10.1111/j.1423-0410.2009.01272.x
  16. Lin YH, Wang Y, Loua A, Day GJ, Qiu Y, Nadala EC Jr, et al. Evaluation of a new hepatitis B virus surface antigen rapid test with improved sensitivity. J Clin Microbiol 2008;46:3319-24. https://doi.org/10.1128/JCM.00498-08
  17. Bottero J, Boyd A, Gozlan J, Lemoine M, Carrat F, Collignon A, et al. Performance of rapid tests for detection of HBsAg and anti-HBsAb in a large cohort, France. J Hepatol 2013;58:473-8. https://doi.org/10.1016/j.jhep.2012.11.016
  18. Denniston MM, Klevens RM, McQuillan GM, Jiles RB. Awareness of infection, knowledge of hepatitis C, and medical follow-up among individuals testing positive for hepatitis C: National Health and Nutrition Examination Survey 2001-2008. Hepatology 2012;55:1652-61. https://doi.org/10.1002/hep.25556
  19. Hyun J, Ko DH, Kang HJ, Whang DH, Cha YJ, Kim HS. Evaluation of the VIDAS anti-HCV assay for detection of hepatitis C virus infection. Ann Lab Med 2016;36:550-4. https://doi.org/10.3343/alm.2016.36.6.550
  20. Park Y, Park JY, Kim MJ, Kim HS. Comparison of the diagnostic performance of Elecsys Anti-HCV II and Elecsys and Vitros Anti-HCV assays. J Lab Med Qual Assur 2012;34:51-6.
  21. Esteban JI, van Helden J, Alborino F, Burgisser P, Cellerai C, Pantaleo G, et al. Multicenter evaluation of the $Elecsys^{(R)}$ anti-HCV II assay for the diagnosis of hepatitis C virus infection. J Med Virol 2013;85:1362-8. https://doi.org/10.1002/jmv.23536
  22. Kim S, Kim JH, Yoon S, Park YH, Kim HS. Clinical performance evaluation of four automated chemiluminescence immunoassays for hepatitis C virus antibody detection. J Clin Microbiol 2008;46:3919-23. https://doi.org/10.1128/JCM.01603-08
  23. Oh EJ, Chang J, Yang JY, Kim Y, Park YJ, Han K. Different signal-to-cut-off ratios from three automated anti-hepatitis C virus chemiluminescence immunoassays in relation to results of recombinant immunoblot assays and nucleic acid testing. Blood Transfus 2013;11:471-3.
  24. Zacher BJ, Moriconi F, Bowden S, Hammond R, Louisirirotchanakul S, Phisalprapa P, et al. Multicenter evaluation of the Elecsys hepatitis B surface antigen quantitative assay. Clin Vaccine Immunol 2011;18: 1943-50. https://doi.org/10.1128/CVI.05122-11
  25. Louisirirotchanakul S, Khupulsup K, Akraekthalin S, Chan KP, Saw S, Aw TC, et al. Comparison of the technical and clinical performance of the Elecsys HBsAg II assay with the Architect, AxSym, and Advia Centaur HBsAg screening assays. J Med Virol 2010;82:755-62. https://doi.org/10.1002/jmv.21706
  26. Yoo SJ, Wang LL, Ning HC, Tao CM, Hirankarn N, Kuakarn S, et al. Evaluation of the Elecsys Anti-HCV II assay for routine hepatitis C virus screening of different Asian Pacific populations and detection of early infection. J Clin Virol 2015;64:20-7. https://doi.org/10.1016/j.jcv.2014.12.015
  27. Popp C, Krams D, Beckert C, Buenning C, Queiros L, Piro L, et al. HBsAg blood screening and diagnosis: performance evaluation of the ARCHITECT HBsAg qualitative and ARCHITECT HBsAg qualitative confirmatory assays. Diagn Microbiol Infect Dis 2011;70:479-85. https://doi.org/10.1016/j.diagmicrobio.2011.03.022
  28. Tuaillon E, Mondain AM, Nagot N, Ottomani L, Kania D, Nogue E, et al. Comparison of serum HBsAg quantitation by four immunoassays, and relationships of HBsAg level with HBV replication and HBV genotypes. PLoS One 2012;7:e32143. https://doi.org/10.1371/journal.pone.0032143

피인용 문헌

  1. Performance Evaluation of the Automated Fluorescent Immunoassay System Rotavirus Assay in Clinical Samples vol.39, pp.1, 2018, https://doi.org/10.3343/alm.2019.39.1.50
  2. An Automated, Quantitative, and Multiplexed Assay Suitable for Point-of-Care Hepatitis B Virus Diagnostics vol.9, pp.1, 2019, https://doi.org/10.1038/s41598-019-52147-z
  3. Evaluation of high‐throughput digital lateral flow immunoassays for the detection of influenza A/B viruses from clinical swab samples vol.92, pp.8, 2018, https://doi.org/10.1002/jmv.25626
  4. Point of Care Diagnostic Testing for Hepatitis B Virus vol.19, pp.3, 2020, https://doi.org/10.1007/s11901-020-00531-z
  5. Schnelltestdiagnostik sexuell übertragbarer Infektionen : Gemeinsame Stellungnahme von DSTIG, RKI, PEI sowie den Referenzzentren für HIV, HBV und HCV und Konsiliarlaboren für Chlamydien vol.63, pp.10, 2018, https://doi.org/10.1007/s00103-020-03218-4
  6. Performance evaluation of Automated Fluorescent Immunoassay System ROTA and NORO for detection of rotavirus and norovirus: A comparative study of assay performance with RIDASCREEN® Rota vol.35, pp.1, 2018, https://doi.org/10.1002/jcla.23585
  7. Monitoring hepatitis B by using point-of-care testing: biomarkers, current technologies, and perspectives vol.21, pp.2, 2018, https://doi.org/10.1080/14737159.2021.1876565
  8. Hepatitis C virus (HCV) diagnosis via microfluidics vol.13, pp.6, 2018, https://doi.org/10.1039/d0ay02045a
  9. A COVID-19 Exposure at a Dental Clinic Where Healthcare Workers Routinely Use Particulate Filtering Respirators vol.18, pp.12, 2018, https://doi.org/10.3390/ijerph18126481
  10. Bio-nanogate manipulation on electrode surface as an electrochemical immunosensing strategy for detecting anti-hepatitis B surface antigen vol.143, pp.None, 2018, https://doi.org/10.1016/j.bioelechem.2021.107952