임상검사실에서의 액체크로마토그래피-질량분석을 위한 권고안: 제2편. 검사법 검증
Recommendations for Liquid Chromatography-Mass Spectrometry in the Clinical Laboratory: Part II. Method Validation
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진단검사의학 분야에서 정확한 진단을 위하여 액체크로마토그 래피-탠덤질량분석기(liquid chromatography-tandem mass spectrometry, LC-MS/MS)를 이용한 검사의 수요는 증가할 것으로 예상 되지만, 여러 가지 이유로 LC-MS/MS 검사를 임상검사실에 도입하 는 것은 여전히 쉽지 않다. 임상검사실에서 LC-MS/MS 검사 도입 시 검사 성능 평가 방법은 종류가 다양하고 아직까지 표준화되어 있지 않은 실정이다. 따라서, 새로운 LC-MS/MS 검사를 임상검사실 에 도입하고자 할 때 필요한 검증 방법의 종류와 평가 기준에 대하 여 여러 자료를 수집하고 분석하여 기술하고자 하였다. 국내 및 국 외의 관련 자료를 검토하여 최소한으로 필요한 검증 항목과 평가 방법 및 기준을 포함하였다. 정량검사의 전체 검증 시 일반적으로 필요한 항목과 여러 지침을 참고하여 정확도, 정밀도, 보정, 특이 도, 이온화 억제 및 향상, 검출한계/정량한계, 안정성, 참고구간, 잔 효, 그리고 희석연속성 등의 검증항목에 대해 기술하였다. 이 중 정확도, 정밀도, 보정, 특이도, 이온화 억제 및 향상 등의 다섯 항목 은 LC-MS/MS 정량 검사법 검증의 필수 항목으로 여러 가이드라인 에서 공통적으로 제시하고 있다. 그 외 검출한계/정량한계, 안정 성, 참고구간, 잔효, 희석연속성 등은 검사 및 물질의 특성에 따라 추가 검증이 필요한 항목들이다
Abstract
The demand for obtaining test results using liquid chromatography-tandem mass spectrometry (LC-MS/MS) for accurate diagnosis in the field of laboratory medicine is expected to increase, but it is still not easy to introduce diagnostic methods using LC-MS/MS into clinical laboratories for many reasons. There are many different methods used to evaluate the performance of LC-MS/MS in clinical laboratories, which have not been standardized to date. Thus, various data have been analyzed and described based on the type of validation method used and the criteria needed to introduce a new test using LC-MS/MS in a clinical laboratory. Relevant data from home and abroad were reviewed to include the minimum number of validation items required and methods of implementation. In general, the items required for a full validation of the quantitative test and various guidelines were used to summarize the following validation items: accuracy, precision, calibration, specificity, ion suppression or improvement, limit of detection, limit of quantification, stability, reference interval, carryover, and dilution integrity. Among these, the first five items mentioned beforehand are essential parameters for LC-MS/MS validation and are presented in numerous guidelines. The other parameters are required for further verification depending on the characteristics of the analysis and the analytes. This recommendation is intended to outline and present the validation methods that should be carried out when introducing new tests in clinical laboratories using LC-MS/MS with reference to the existing guidelines and literature containing expert opinions.
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