Lab Med Online.  2020 Apr;10(2):95-108. 10.3343/lmo.2020.10.2.95.

Recommendations for Liquid Chromatography-Mass Spectrometry in the Clinical Laboratory: Part II. Method Validation

Affiliations
  • 1Department of Laboratory Medicine, Pusan National University Hospital, Busan, Korea
  • 2Department of Laboratory Medicine, Chonnam NationalUniversity Medical School and Hospital, Gwangju, Korea
  • 3Department of Laboratory Medicine, Green Cross Laboratories, Yongin, Korea
  • 4Department ofLaboratory Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
  • 5Department ofLaboratory Medicine, Yonsei University College of Medicine, Seoul, Korea
  • 6Department of Laboratory Medicine, Seoul National University College ofMedicine, Seoul National University Hospital, Seoul, Korea
  • 7Department of Laboratory Medicine and Genetics, Samsung Medical Center,Sungkyunkwan University School of Medicine, Seoul, Korea

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.

Keyword

Liquid chromatography-tandem mass spectrometry; Recommendation; Validation; Clinical laboratories

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