검출능의 평가 및 설정
Evaluating and Establishing Detection Capabilities
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초록
검사법 및 의학의 발전에 따라 더욱 낮은 농도 혹은 양의 분석물질을 정확히 검출 및 보고하는 것이 중요해졌다. 이에 의학적 요구와불확도 기준을 모두 최대한으로 만족하는 검출능을 설정하고 평가하는 것은 검사법의 수행능 특성 평가는 물론 체외진단의료기기의 평가에 있어서도 필수 요소 중의 하나이다. 검출능은 공시료측정치의 한계(limit of blank, LoB), 검출 한계(limit of detection, LoD), 정량 한계(limit of quantitation, LoQ)의 세 가지로 나눌 수있다. 검출능에 대한 가이드라인인 CLSI EP17이 나와있지만, 많은검사실에서는 이를 실제로 적용하지 못하는 경우가 많다. 이에 본종설에서는 검출능의 검증 및 검정 과정에 대해 기본 개념 및 설명을 제시하고 예시를 통해 실무적 측면에서 쉽게 서술함으로써 국내 진단검사의학과 전문의, 전공의, 임상병리사 및 관련 업계 종사자들에게 실질적인 도움을 주고자 한다. 본 종설에서는 검출능 관련 정의 및 개념, LoB, LoD, LoQ 각각에 대한 검증 및 검정 과정에대해 다루고 있다. 본 종설을 통해 각 임상 검사실 및 관련 업계에서 검출능에 대한 이해를 넓히고, 정립된 프로토콜을 통해 이를설정 및 평가함으로써 국내의 진단검사 품질을 향상시키는 데에기여할 수 있을 것으로 기대된다.
Abstract
With the development of laboratory methods and clinical medicine, accurately detecting and reporting the value of samples with a low concentration or amounts of an analyte with interest has become important. Therefore, establishing and evaluating the detection capabilities that maximally satisfy both medical needs and the criteria for uncertainty is essential in evaluating the performance of laboratory methods as well as in vitro diagnostic medical devices. The detection capabilities can be divided into three categories: limit of blank (LoB), limit of detection (LoD), and limit of quantitation (LoQ). Although Clinical Laboratory Standards Institute EP17, a practical guideline for detection capabilities, is provided, many laboratories have not applied it in practice. Therefore, this review article aims to provide practical help to domestic clinical pathologists, residents, medical technologists, and related industry workers by presenting basic concepts and explanations for validating and verifying the detection capabilities and easily describing them in practical terms through some examples. This review deals with the definitions and concepts related to detection capabilities, and LoB, LoD, and LoQ validation and verification process. This review is expected to improve the quality of diagnostic tests in Korea by expanding the understanding of the detection capabilities in each clinical laboratory and related industry and establishing and evaluating them through these established protocols.
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