한국융합학회논문지 (Journal of the Korea Convergence Society)

  • 제9권3호
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  • Pages.165-171
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  • 2018
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  • 2233-4890(pISSN)
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  • 2713-6353(eISSN)
한국융합학회 (Korea Convergence Society)
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인플루엔자 바이러스에 대한 신속 항원 검출 검사 검출한계의 융합적 분석

Fusion Analytical Sensitivity of Rapid Influenza Antigen Limit of Detection Tests for Human Influenza virus

  • 송창섭 (동남보건대학교 임상병리과) ;
  • 성현호 (동남보건대학교 임상병리과) ;
  • 김정현 (경복대학교 임상병리과) ;
  • 김대은 (경복대학교 임상병리과) ;
  • 박창은 (남서울대학교 임상병리학과 분자진단연구소) ;
  • 윤중수 (경동대학교 임상병리학과)
  • Song, Chang-Sub (Department of Clinical Laboratory Science, Dongnam Health University) ;
  • Sung, Hyun-Ho (Department of Clinical Laboratory Science, Dongnam Health University) ;
  • Kim, Jung-Hyun (Department of Clinical Laboratory Science, Jinju Health University) ;
  • Kim, Dae-Eun (Department of Clinical Laboratory Science, Jinju Health University) ;
  • Park, Chang-Eun (Department of Biomedical Laboratory Science, Molecular Diagnostics Research Institute, Namseoul University) ;
  • Yoon, Joong-Soo (Department of Clinical Laboratory Science, Kyunhdong University)
  • 투고 : 2018.02.07
  • 심사 : 2018.03.20
  • 발행 : 2018.03.28
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초록

본 논문은 국내 인플루엔자 신속항원검사키트의 민감도의 검출한계를 분석하기위하여 국내 시판중인 인플루엔자 신속항원검사키트 5종을 대상으로 인플루엔자 바이러스 A형과 B형 배양액을 연속 희석하여 양성 검출 한계를 분석하였다. 분석 결과 A형의 육안측정결과는 웰스바이오 제품은 1:8192까지, II제품은 1:4096까지, I과 III제품은 1:512까지, IV제품은 1:128에서만 양성이 확인되었고, B형 육안측정결과는 웰스바이오 제품이 1:8192까지, II제품은 1:4096까지, I, III, IV제품의 경우 1:1024까지 양성이 확인되었다. 같은 검체의 기기 판독의 경우 A형, B형 모두 웰스바이오 제품이 1:8192까지, II제품이 1:4096까지, I제품은 1:2048까지 양성으로 확인되었다. 인플루엔자 신속항원검사의 민감도는 환자의 검체 채취부위 및 감염기간, 검체의 양 등에 따라 많은 차이가 있으므로, 검체의 채취시기 및 방법 등을 정확하게 준수해야할 것이며, 신속항원검사 키트의 민감도를 높이기 위한 다각적인 연구가 필요할 것으로 사료된다.

In this study, to analyze the detection of limit for sensitivity of the influenza rapid antigen test kit, the positive detection of limits were analyzed by serial dilution of influenza virus A and B type for five influenza rapid antigen test kits in Korea. As a result of analysis, visual measurement of type A were up to 1:8192 for the Wellsbio product and up to 1:4096 for the II product, up to 1:512 for the I and III products, and only 1:128 for the IV product, and type B were positive for up to 1:8192 for the Wellsbio product, up to 1: 4096 for the II product and up to 1:1024 for the I, III and IV products. For instrument readings with the same specimen, both A and B types were found to be positive for up to 1:8192 for the Wellsbio product, up to 1: 4096 for the II product, and up to 1:2048 for the I product. The sensitivity of the rapid antigen test for influenza differs greatly depending on the sampling area of the patient, infection period, specimen volume, etc. Therefore, it is necessary to observe exactly the collection timing and method of the specimen. And it is necessary further study to improve the sensitivity for influenza rapid antigen test.

키워드

참고문헌

  1. S. Y. Ryu. (2017). Influenza, The Korean Journal of Medicine, 92(6), 494-498. DOI: https://doi.org/10.3904/kjm.2017.92.6.494
  2. P. F. Wright, G. Neumann & Y. Kawaoka. (2007). Orthomyxoviruses. In: D. M. Knipe, P. M. Howley, editors. Fields virology, 5th ed. Philadelphia: Wolters Kluwer Health/Lippincott, Williams and Wilkins; 1691-1740.
  3. J. W. Choi, H. J..Cho, H. M..Kim & S. Hahn. (2014). Clinical and Laboratory Findings of the 2012 Winter Seasonal Influenza A and B. Pediatric Infection and Vaccine 21, 1-8. DOI:http://dx.doi.org/10.14776/kjpid.2014.21.1.1
  4. C. S. Lee. (2010). The Diagnosis and Treatment of Influenza. The Journal of the Korean Medical Association, 53(1), 43-51. https://doi.org/10.5124/jkma.2010.53.1.43
  5. L. J. Elden, G. A. Essen, C. A. Boucher, A. M. Loon, M. Nijhui & P. Schipper, et al. (2001). Clinical diagnosis of influenza virus infection : evaluation of diagnostic tools in general practice. British Journal of General Practice, 51, 630-34.
  6. K. H. Chan, N. Maldeis, W. Pope, A. Yup, A. Ozinskas & J. Gill, et al. (2002). Evaluation of the Directigen Flu A+B test for rapid diagnosis of influenza virus type A and B infections. Journal of Clinical Microbiology, 40, 1675-1680. https://doi.org/10.1128/JCM.40.5.1675-1680.2002
  7. A. Ruest, S. Michaud, S. Deslandes & E. H Frost. (2003). Comparison of the Directigen Flu A+B test, the QuickVue influenza test, and clinical case definition to viral culture and reverse transcription-PCR for rapid diagnosis of influenza virus infection", Journal of Clinical Microbiology, 41, 3487-493. https://doi.org/10.1128/JCM.41.8.3487-3493.2003
  8. J. H. Song, J. S. Park, Y. J. Choi, H. L. Kim, H. S. Nam & Y. B. Kim. (2009). Clinical Utility of Rapid Influenza Antigen Test. Journal of Soonchunhyang Medical Science, 15(1), 125-132.
  9. C. G Grijalva, K. A. Poehling, K. M. Edwards, G. A. Weinberg, M. A. Staat & M. K. Iwane, et al. (2007). Accuracy and interpretation of rapid influenza tests in children. Pediatrics, 119, 6-11.
  10. A. Kwon, J. S. Kim, H. S. Kim, W. Song, J. Y. Park, H & C. Cho, et al. (2010). Comparison of rapid antigen test and real-time reverse transcriptase PCR for diagnosing novel swine influenza A(H1N1). Korean Journal of Clinical Microbiology, 13, 109-113. https://doi.org/10.5145/KJCM.2010.13.3.109
  11. S. Vasoo, J. Stevens & K. Singh. (2009). Rapid antigen tests for diagnosis of pandemic (Swine) influenza A/H1N1. Clinical Infectious Diseases, 49, 1090-1093. https://doi.org/10.1086/644743
  12. Centers for Disease Control and Prevention. (2009). Evaluation of rapid influenza diagnostic tests for detection of novel influenza A (H1N1) virus-United States. Morbidity and Mortality Weekly Report, 58, 826-829.
  13. J. F. Drexler, A. Helmer, H. Kirberg, U. Reber, M. Panning, M. Muller, K. Hofling, B. Matz, C. Drosten & A. M. Eis-Hubinger. (2009). Poor clinical sensitivity of rapid antigen test for influenza A pandemic (H1N1) 2009 virus. Emerging Infectious Diseases, 5, 1662-1664.
  14. D. J Faix, S. S Sherman & S. H. Waterman. (2009). Rapid-test sensitivity for novel swine-origin influenza A(H1N1) virus in humans. The New England Journal of Medicine, 361(7), 728-729. https://doi.org/10.1056/NEJMc0904264
  15. J. S. Kim, H. J. Choi, Y. M. Ahn & Y. O. Hwang. (2005). Clinical Usefulness of Rapid Antigen Test on the Diagnosis of Influenza. Korean Journal of Pediatrics, 48(12), 1348-1353.
  16. D. H. Kwon, K. C. Shin, M. H. Kwon, H. B. Oh, C. Kang & J. Y. Lee. (2011). Development and Evaluation of a Rapid Influenza Diagnostic Test for the Pandemic (H1N1) 2009 Influenza Virus. Journal of Clinical Microbiol, 49(1), 437-438. https://doi.org/10.1128/JCM.01628-10
  17. H. J. Lee. (2012). Rapid diagnostic tests for influenza. Public health weekly report, KCDC, 5(8), 137-145.
  18. J. Y. Lee, S. Lee, H. S. Kim & K. N. Kim. (2017). The Efficacy of Rapid Antigen Tests for Detection of Seasonal Influenza Virus. Pediatric Infection and Vaccine, 24(1), 31-36. https://doi.org/10.14776/PIV.2017.24.1.31
  19. H. Wang, S. Guo, Z. Li X. Xu, Z. Shao & G. Song. (2017). Suspension culture process for H9N2 avian influenza virus (strain Re-2). Archives of Virology, 162(10), 3051-3059 https://doi.org/10.1007/s00705-017-3460-8
  20. M. J. Park, H. S. Kim, Y. K. Lee & H. J. Kang, J. S. Kim, W. K. Song, K. M. Lee. (2012). Comparison of Rapid Antigen Test and Real-Time Reverse. Journal of Laboratory Medicine and Quality Assurance, 34, 93-97.
  21. Y. K. Kim, H. Y. Kim, U. Uh & J. K. Chun. (2010). Detection Rate of Rapid Antigen Test for Pandemic Influenza A (H1N1 2009). Infection & Chemotherapy, 42(2), 95-98. https://doi.org/10.3947/ic.2010.42.2.95
  22. W. G. Lee, H. K. Lee, H. J. Kim, J. K. Chung, E. H. Lee & H. R. Moon. (2004). Evaluation of a Rapid Antigen Test for Detection of Influenza Virus. Korean Journal of Clinical Microbiology, 7(2), 119-123.
  23. B. K. Lee, J. K. Ju, B. S. Choi, S. G. Jung, J, A. Jung & H. J. Yun. (2012). Usefulness of Influenza Rapid Antigen Test in Influenza A (H1N1). Allergy Asthma & Respiratory Disease, 22(1), 71-77.
  24. J. Y. Lee, S. Lee, H. S. Kim & K. N. Kim, (2017) The Efficacy of Rapid Antigen Tests for Detection of Seasonal Influenza Virus. Pediatric Infection and Vaccine, 24(1), 31-36. https://doi.org/10.14776/PIV.2017.24.1.31
  25. S. R. Ryu, J. H. Shin, S. Y. Baek, J. O. Kim & K. I. Min, at al. (2003). Evaluation of Limit of Cetection and Range of Quantitation for RT-PCR, Real-Time RT-PCR and RT-PCR-ELISA Detection of Bovin Viral Diarrhoea Virus Contamination in Biologics Derived from Cell Cultures. Journal of Bacteriology and Virology, 33(2), 161-168