Laboratory Medicine and Quality Assurance

Korean Association of External Quality Assessment Service (대한임상검사정도관리협회)
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Report on the External Quality Assessment Scheme of Hepatitis Viral Markers in Korea, (2016-2017)

간염바이러스 항원항체검사 신빙도조사 결과보고 (2016-2017)

  • Cho, Eun-Jung (Department of Laboratory Medicine, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Choi, Ae Ran (Department of Laboratory Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Ryu, Ji Hyeong (Department of Laboratory Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Yun, So Jeong (Department of Laboratory Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Lee, Woochang (Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Chun, Sail (Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Min, Won-Ki (Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Oh, Eun-Jee (Department of Laboratory Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea)
  • 조은정 (가톨릭대학교 의과대학 의정부성모병원 진단검사의학과) ;
  • 최애란 (가톨릭대학교 의과대학 서울성모병원 진단검사의학과) ;
  • 류지형 (가톨릭대학교 의과대학 서울성모병원 진단검사의학과) ;
  • 윤소정 (가톨릭대학교 의과대학 서울성모병원 진단검사의학과) ;
  • 이우창 (울산대학교 의과대학 서울아산병원 진단검사의학과) ;
  • 전사일 (울산대학교 의과대학 서울아산병원 진단검사의학과) ;
  • 민원기 (울산대학교 의과대학 서울아산병원 진단검사의학과) ;
  • 오은지 (가톨릭대학교 의과대학 서울성모병원 진단검사의학과)
  • Published : 2018.06.30
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Abstract

As part of the immunoserology program of the Korean Association of External Quality Assessment Service, we organized two trials on the external quality assessment of hepatitis viral markers in 2016 and 2017. The hepatitis viral antigens and antibodies program consisted of 10 test items. We delivered two and three types of pooled sera specimens to 965 and 965 institutions for the first and second trials of external proficiency testing in 2016, respectively. The number of participating laboratories was 915 (94.8%) and 913 (95.0%) in the first and second trials in 2016, respectively. We also delivered three kinds of pooled sera specimens to 936 and 1,015 institutions for the first and second trials of external proficiency testing in 2017, respectively. The number of participating laboratories was 920 (98.3%) and 996 (98.1%) in the first and second trials in 2017, respectively. The most commonly tested items were hepatitis B surface antigen, followed by the antibodies to hepatitis B surface antigen, anti-hepatitis C virus, hepatitis B envelope antigen, antibodies to hepatitis B envelope antigen, anti-hepatitis A virus and antibodies to hepatitis B core antigen. The most frequently used methods for detecting viral markers were the chemiluminescence immunoassay and the electrochemiluminescence immunoassay, but they yielded a few-false positive results due to the matrix effect. The immunochromatographic assay yielded false-negative results for anti-hepatitis A virus due to low sensitivity. Continuous improvement in the quality of viral hepatitis testing through participation in the survey seems necessary.

대한임상검사정도관리협회 면역혈청프로그램의 2016년 간염바이러스 항원항체검사 신빙도조사 사업은 6월과 10월에, 2017년 신빙도조사사업은 5월과 10월에 2회에 걸쳐 시행되었다. 간염바이러스 항원항체검사 신빙도조사사업은 총 10종목에 대하여 실시하였다. 저자들은 2016년 1회차 2개, 2회차 3개의 혼합혈청 검체를 각각 965기관, 962기관에 발송하였다. 참여기관은 1회차에 915 기관(94.8%), 2회차 913기관(95.0%)이었다. 2017년도에는 매 회차 3개의 혼주혈청 검체를 각각 936기관, 1,015기관에 발송하였다. 참여기관은 1회차에 920기관(98.3%), 2회차 996기관(98.1%) 이었다. Hepatitis B surface antigen에 가장 많은 기관이 참여하였고, hepatitis B surface antigen, anti-hepatitis C virus, hepatitis B envelope antigen, antibodies to hepatitis B envelope antigen, anti-hepatitis A virus 및 antibodies to hepatitis B core antigen 순으로 참여하였다. 간염바이러스 항원항체검사 신빙도조사 결과, matrix effect로 인하여 전기화학발광면역검사법을 포함한 화학발광면역검사법에서 위양성 결과가 발생하였다. Anti-hepatitis A virus검사에서 면역크로마토그래피법의 낮은 민감도는 위음성 결과를 초래하였다. 검사실의 간염바이러스 신빙도조사사업의 지속적인 참여를 통한 검사의 질 향상이 필요할 것으로 생각되었다.

Keywords

Acknowledgement

Supported by : 대한임상검사정도관리협회

Cited by

  1. Report of the Korean Association of External Quality Assessment Service on Hepatitis Serology (2018-2019) vol.42, pp.4, 2018, https://doi.org/10.15263/jlmqa.2020.42.4.166