Lab Med Online.  2020 Jul;10(3):185-196. 10.3343/lmo.2020.10.3.185.

Recommendations for Liquid Chromatography-Mass Spectrometry in the Clinical Laboratory: Part III. Quality Assurance

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

Abstract

The use of liquid chromatography-tandem mass spectrometry (LC-MS/MS) in clinical laboratories is increasing and is likely to expand into even more clinical venues in the future. Mass spectrometry is the standard method for analyte identification in the clinical chemistry field; however, differences in mass spectrometry protocols and handling affect the accuracy and reliability of these tests and prevent direct comparisons of results between laboratories. For example, the results of laboratories using LC-MS/MS methods are less likely to be reproducible than those of laboratories using conventional, automated methods. This is due to inadequate handling of the equipment and/or poor quality control after the implementation of the method, which may result in unnecessary medical expenditures or even adverse outcomes for the patients. Unfortunately, guidelines to monitor the accuracy of LC-MS/MS-based clinical tests are still lacking. In general, the quality control methods used in conventional clinical tests could also be applied to LC-MS/MS. However, additional quality control methods specific to LC-MS/MS techniques must be continuously employed to maintain the same quality level achieved during method development and verification. This report is intended to help clinical laboratories that operate LC-MS/MS improve the accuracy and reliability of their testing by providing guidance for quality assurance and improvement, based on a collection of existing guidelines and expert opinions from the literature.

Keyword

Liquid chromatography-tandem mass spectrometry; Recommendation; Clinical testing; Quality assurance; Quality control; Post-implementation monitoring; Clinical laboratories
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