Korean Journal of Clinical Laboratory Science (대한임상검사과학회지)

Korean Society for Clinical Laboratory Science (대한임상검사과학회)
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Association between False Positive, False Negative, High-Background Cases and Humidity in One Lambda LABTypeTM HLA-DR Typing

One Lambda LABTypeTM을 이용한 HLA- DR Typing시 나타나는 위양성과 위음성, High-Background 사례와 검사실 습도의 관계분석

  • Hyang Son AN (Department of Laboratory Medicine, Seoul National University Hospital) ;
  • Minsung SOHN (Division of Health Care Science, The Cyber University of Korea)
  • 안향선 (서울대학교병원 진단검사의학과) ;
  • 손민성 (고려사이버대학교 보건의료학부)
  • Received : 2023.07.23
  • Accepted : 2023.08.25
  • Published : 2023.09.30
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Abstract

Human leukocyte antigen (HLA) typing was performed in the diagnostic immunology laboratory of the Seoul National University Hospital. Among 611 HLA-DR tests, specific bead reactions suspected of being false positive and false negative in Lot 20 reagents were found. Therefore, we aimed to identify the factors causing cut-off corrections by examining cases where cut-off corrections were not made for 533 test results and cases where cut-off corrections were made for 78 cases after the cut-off corrections of specific beads. Frequency analysis was conducted to verify the demographic characteristics, and descriptive statistics were used to assess the humidity in the laboratory as a variable. Cross-tabulation was done to examine the association between cut-off corrections and demographic characteristics. Independent samples t-tests were conducted to verify the difference in humidity based on cut-off corrections. Finally, logistic regression analysis was conducted to examine the relationship between humidity levels and the rate of cut-off corrections, and results showed as the humidity level in the laboratory highs, the number of cut-off corrections decreased by a factor of 0.986. This suggests cut-off corrections rate increases when the humidity lowers. Therefore, it indicates that humidity in the laboratory is also a factor that affects HLA typing results.

서울대학교병원 진단면역검사실에서 HLA 형별 검사를 위한 결과 산출하는 과정에서 HLA-DR 검사 시행 건수 총 611건 중 Lot No.20의 시약에서 빈번히 나타나는 위양성과 위음성으로 의심되는 특이 bead 들의 반응을 발견하게 되었다. 따라서 정확한 결과 산출과정을 모색하기 위하여 특이 bead들의 cut-off 수정을 하지 않은 검사결과 533건과 특이 bead의 cut-off 수정을 한 뒤 결과 산출을 한 78건의 사례들을 가지고 cut-off 수정을 야기시키는 요인을 여러 변수로서 규명하고자 하였다. 검체대상의 인구통계특성과 cut-off 수정 여부를 확인하기 위해 빈도분석, 검사실의 습도를 변수로 넣어 기술통계를 진행하였고, cut-off 수정 여부와 인구통계특성의 연관성을 확인하기 위하여 교차분석을 시행, cut-off 수정 여부에 따른 습도의 차이를 검증하기 위해 독립표본 t검증을 실시하였다. 마지막으로 습도수준에 따른 cut-off 수정비율의 관계를 검증하기 위해 로지스틱 회귀분석을 실시하였다. 결과적으로 검사실의 습도 수준이 증가함에 따라 cut-off 수정사례는 0.986배 감소하는 것으로 나타났다. 이는 습도가 낮아질수록 cut-off 수정률이 증가한다는 것을 의미한다. 따라서 검사실의 습도 또한 HLA typing 결과에 영향을 미치는 요인임을 시사한다.

Keywords

Acknowledgement

This article is based on a part of the first author's master's thesis.

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