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

김연; 박선영; 김정호; 장연희; 하선목; 최연임; 이혜영

doi:10.15324/kjcls.2018.50.1.20

미국 FDA 허가사례를 통해 본 결핵균 및 비결핵 항산균 체외진단용 시약의 성능평가
Performance Evaluation of In Vitro Diagnostic Reagents for Mycobacterium tuberculosis and Non-tuberculous Mycobacteria by FDA Approval 원문보기

Korean journal of clinical laboratory science : KJCLS = 대한임상검사과학회지, v.50 no.1, 2018년, pp.20 - 28

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)

초록
AI-Helper

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.

Abstract ▼ AI-Helper

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.

주제어

AI 본문요약
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문제 정의

최근 식약청은 결핵균 및 비결핵 항상균 체외 진단 시약에 대한 가이드 라인을 발표했다. 본 연구에서는, 미국 FDA에 승인을 받은 결핵균 및 비결핵 항산균 에 대한 체외 진단 시약의 성능을 검토하였다. 이 검토는 결핵균 및 비결핵 항상균 체외 진단 시약 평가에 유용한 참고 자료가 될 것으로 사료된다.

대상 데이터

We compared the FDA-approved in vitro diagnostic reagents for detecting TB and those that were not approved by the FDA were evaluated for their performance using commercially available reagents. For Xpert MTB/RIF diagnostic reagent, respiratory specimens were used mainly and samples were analyzed using a minimum of 121 samples and a maximum of 2910 samples. The mean sensitivity was 79.

성능/효과

9% (746/762) as 17 non-determinate results were obtained. Positive predictive value (PPV) was changed from 94.9% to 93.3% and negative predictive value (NPV) was changed from 97.6% to 98.5%.
The results of the present study were as follows: 1) In vitro evaluation of non-tuberculous antibiotics was performed on cultured specimens and the average value of FDA - approved Accuprobe avium complex diagnostic reagents was 87.4%. In the case of INNO-LiPA Mycobacteria v.
6% (33/39), respectively. When the test was repeated twice, the sensitivity increased from 87.5% to 96.9% for smear positive samples and from 64% to 72% for smear negative samples. The specificity was changed from 100% to 100% for smear positive samples and 100% to 99.

후속연구

본 연구에서는, 미국 FDA에 승인을 받은 결핵균 및 비결핵 항산균 에 대한 체외 진단 시약의 성능을 검토하였다. 이 검토는 결핵균 및 비결핵 항상균 체외 진단 시약 평가에 유용한 참고 자료가 될 것으로 사료된다.

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용어 설명 출처 목록 (6)

용어 설명: PCR은 세균 특이성이 있는 primer를 이용하여 적은 수의 세균이 있을지라도 쉽게 검출할 수 있는 유용한 방법이며, 이를 이용하여 구강 내 치면세균막이나 타액에서 직접 세균을 검출할 수 있게 되었다[8].

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