Korean Journal of Clinical Laboratory Science (대한임상검사과학회지)

Korean Society for Clinical Laboratory Science (대한임상검사과학회)
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Performance Evaluation of In Vitro Diagnostic Reagents for Mycobacterium tuberculosis and Non-tuberculous Mycobacteria by FDA Approval

미국 FDA 허가사례를 통해 본 결핵균 및 비결핵 항산균 체외진단용 시약의 성능평가

  • Kim, Yeun (Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University) ;
  • Park, Sunyoung (Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University) ;
  • Kim, Jungho (Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University) ;
  • Chang, Yunhee (Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University) ;
  • Ha, Sunmok (Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University) ;
  • Choi, Yeonim (Department of Biomedical Laboratory Science, Songho College) ;
  • Lee, Hyeyoung (Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University)
  • 김연 (연세대학교 보건과학대학 임상병리학과) ;
  • 박선영 (연세대학교 보건과학대학 임상병리학과) ;
  • 김정호 (연세대학교 보건과학대학 임상병리학과) ;
  • 장연희 (연세대학교 보건과학대학 임상병리학과) ;
  • 하선목 (연세대학교 보건과학대학 임상병리학과) ;
  • 최연임 (송호대학교 임상병리과) ;
  • 이혜영 (연세대학교 보건과학대학 임상병리학과)
  • Received : 2017.12.05
  • Accepted : 2017.12.27
  • Published : 2018.03.31
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Abstract

Tuberculosis (TB) is a bacterial infection disease caused by members of the species Mycobacterium tuberculosis (MTB) complex. Approximately one third of the world's population is infected with TB. In Korea, approximately 40,000 new patients are identified each year. Moreover, infections from non-tuberculous mycobacteria (NTM) have also increased. In the diagnosis of TB and NTM, traditional bacterial cultures are required for 3 to 4 weeks. Therefore, rapid and accurate diagnostic tests for TB and NTM are needed. To distinguish between TB and NTM, a range of diagnostic methods have been developed worldwide. In vitro diagnostic assays are constantly being developed to meet the increasing need for the rapid and accurate identification for TB and NTM. On the other hand, the performance evaluations of in vitro diagnostic reagents for TB and NTM are lacking. Recently, the Korea Food and Drug Administration (KFDA) issued a guideline for in vitro diagnostic reagents for MTB and NTM. Here, this study analyzed the performance of currently developed in vitro diagnostic reagents for TB and NTM in the US FDA. This analysis of US FDA approved molecular assays could serve as a useful reference for an evaluation of the reagent performance of TB and NTM.

결핵(TB)은 Mycobacterium tuberculosis (MTB) 복합체의 구성원에 의한 세균 감염 질병이다. 결핵은 전 세계 인구의 1/3이 감염된 것으로 알려져 있으며, 한국에서는 매년 약 4만 명의 새로운 결핵환자가 발생한다. 또한, 비결핵 항상균 감염이 증가하고 있는 추세이다. 전통적인 결핵 및 비결핵 항상균 진단방법은 세균 배양으로 3~4주 이상이 소요된다. 따라서, 신속하고 정확한 결핵균(TB) 및 비결핵 항상균(NTM) 진단법의 필요성이 요구되고 있다. 결핵균 및 비결핵 항상균을 구분하기 위하여, 전 세계적으로 다양한 진단 방법이 개발되고 있다. 특히, 결핵균과 비결핵 항상균을 신속하고 정확한 동정의 요구가 증가함에 따라, 정확하고 신속하게 진단하기 위한 체외 진단 방법이 개발 되고 있다. 그러나 현재 결핵과 비결핵 항상균에 대한 체외 진단 시약의 성능 평가는 부족한 실정이다. 최근 식약청은 결핵균 및 비결핵 항상균 체외 진단 시약에 대한 가이드 라인을 발표했다. 본 연구에서는, 미국 FDA에 승인을 받은 결핵균 및 비결핵 항산균에 대한 체외 진단 시약의 성능을 검토하였다. 이 검토는 결핵균 및 비결핵 항상균 체외 진단 시약 평가에 유용한 참고 자료가 될것으로 사료된다.

Keywords

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