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임상검사실에서의 액체크로마토그래피-질량분석을 위한 권고안: 제2편. 검사법 검증

Other Titles
 Recommendations for Liquid Chromatography-Mass Spectrometry in the Clinical Laboratory: Part II. Method Validation 
Authors
 문수영  ;  최현정  ;  김세림  ;  이경훈  ;  이상국  ;  송상훈  ;  이수연  ;  박형두  ;  대한임상화학회 임상질량분석연구위원회 
Citation
 Laboratory Medicine Online, Vol.10(2) : 95-108, 2020-04 
Journal Title
 Laboratory Medicine Online 
Issue Date
2020-04
Keywords
Liquid chromatography-tandem mass spectrometry ; Recommendation ; Validation ; Clinical laboratories
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.
Files in This Item:
T202003549.pdf Download
DOI
10.3343/lmo.2020.10.2.95
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Laboratory Medicine (진단검사의학교실) > 1. Journal Papers
Yonsei Authors
Lee, Sang-Guk(이상국) ORCID logo https://orcid.org/0000-0003-3862-3660
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/179972
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