직선구간과 확장측정구간의 평가 및 설정
Evaluating and Establishing the Linearity Interval and Extended Measuring Interval
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초록
직선성은 검사법의 성능 특성을 평가하는 주요 요소 중 하나로 신규 측정절차의 도입 시는 물론 그 이후에도 정기적으로 평가가 이루어져야 한다. 희석 배수의 검증 및 검정은 측정가능구간(AMI)을 이용하여 확장측정구간(EMI)을 확장하여 보고가능구간(RI)을 설정하는 데 필요한 절차이다. 비록 직선성과 희석배수를 위한 최신 지침인 CLSI EP06, EP34가 나와 있지만, 많은 검사실에서는 이를 실제로 적용하지 못하는 경우가 많다. 이에 본 종설은 직선구간 및 확장측정구간의 설정을 위한 직선성과 희석배수의 검증 및 검정 과정에 대해 기본 개념 및 실무적 측면에서 전반적이며 포괄적으로 서술하여 국내 진단검사의학과 전문의, 전공의, 임상병리사 및 관련 업계 종사자들에게 실질적인 도움이 되고자 한다. 본 종설은 직선성 평가에 대한 개념 및 역사, 직선 구간의 검증 및 검정, AMI, EMI, RI의 개념, 희석배수의 설정, EMI의 검증 및 검증을 다루었다. 본 종설은 국내 임상 검사실 및 관련 업계에서 직선성 및 희석배수에 대한 이해를 넓히고 보다 쉽고 효과적으로 이를 평가함으로써 국내의 진단검사 품질을 향상시키는 데에 기여할 것으로 기대된다.
Abstract
Linearity is one of the major factors in evaluating the performance characteristics of laboratory methods and should be evaluated regularly at the time of introducing a new measurement procedure and as an ongoing process. The validation and verification of the dilution factor are necessary procedures to establish reportable intervals (RIs) through the expansion of extended measuring intervals (EMIs) using analytical measuring intervals (AMIs). Although up-to-date guidelines for linearity and the dilution factor exist, such as the Clinical Laboratory Standards Institute (CLSI) EP06 and EP34, these have not yet been applied to many clinical laboratories in Korea. Therefore, this review article aims to provide practical assistance to clinical pathologist, residents, clinical laboratory technologists, and related industry workers, in Korea, by describing the overall and comprehensive processes of linearity and the dilution factor with regard to basic concepts and practical aspects. This review details the concept and history of linearity evaluation, validation and verification of the linearity interval, concepts of AMI, EMI, and RI, the establishment of the dilution factor, and validation and verification of EMI. This article is expected to contribute to improving the quality of diagnostic tests in Korea by enhancing the understanding of linearity and the dilution factor across clinical laboratories and related industries, thus facilitating easier and more effective evaluation.
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