Use of Liquid Chromatography-Tandem Mass Spectrometry for Clinical Testing in Korean Laboratories: a Questionnaire Survey
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초록
Background: The use of liquid chromatography-tandem mass spectrometry (LC-MS/MS) has substantially increased in clinical laboratories worldwide. To assess the status of clinical LC-MS/MS testing in Korean laboratories, a questionnaire survey was performed by the Clinical Mass Spectrometry Research Committee of the Korean Society of Clinical Chemistry. Methods: The questionnaire was distributed to 19 clinical laboratories performing clinical LC-MS/MS from April to May 2018. It asked about general characteristics of the laboratory and commonly utilized clinical LC-MS/MS tests: newborn screening, tacrolimus test, vitamin D test, and plasma metanephrine test. Frequency analysis and other statistical analyses were performed. Results: A total of 17 laboratories responded. The median number of LC-MS/MS instruments, laboratory medicine physicians, and technicians in each laboratory was three, one, and two, respectively. Nine laboratory directors had >10 years of experience with clinical LC-MS/MS. For each LC-MS/MS test, at least two concentrations of QC materials were measured every 24 hours during clinical testing, and all laboratories used QC acceptability criteria based on their established QC means and SDs. All laboratories participated in an external quality assessment program. However, there was inter-laboratory variability in sample preparation methods, instruments, reagents, internal standards, and calibrators. Conclusions: LC-MS/MS has been successfully introduced in Korean clinical laboratories and is used within a quality framework. Further efforts for harmonization on a nationwide basis could facilitate the widespread use of LC-MS/MS.
Abstract
Background: The use of liquid chromatography-tandem mass spectrometry (LC-MS/MS) has substantially increased in clinical laboratories worldwide. To assess the status of clinical LC-MS/MS testing in Korean laboratories, a questionnaire survey was performed by the Clinical Mass Spectrometry Research Committee of the Korean Society of Clinical Chemistry. Methods: The questionnaire was distributed to 19 clinical laboratories performing clinical LC-MS/MS from April to May 2018. It asked about general characteristics of the laboratory and commonly utilized clinical LC-MS/MS tests: newborn screening, tacrolimus test, vitamin D test, and plasma metanephrine test. Frequency analysis and other statistical analyses were performed. Results: A total of 17 laboratories responded. The median number of LC-MS/MS instruments, laboratory medicine physicians, and technicians in each laboratory was three, one, and two, respectively. Nine laboratory directors had >10 years of experience with clinical LC-MS/MS. For each LC-MS/MS test, at least two concentrations of QC materials were measured every 24 hours during clinical testing, and all laboratories used QC acceptability criteria based on their established QC means and SDs. All laboratories participated in an external quality assessment program. However, there was inter-laboratory variability in sample preparation methods, instruments, reagents, internal standards, and calibrators. Conclusions: LC-MS/MS has been successfully introduced in Korean clinical laboratories and is used within a quality framework. Further efforts for harmonization on a nationwide basis could facilitate the widespread use of LC-MS/MS.
참고문헌 (15)
- Taylor PJ, "High-performance liquid chromatography-mass spectrometry in the clinical laboratory", Ther Drug Monit, 27, pp.689~693 (2005)
- Dooley KC, "Tandem mass spectrometry in the clinical chemistry laboratory", Clin Biochem, 36, pp.471~481 (2003)
- Grebe SK, "LC-MS", MS in the clinical laboratory–where to from here, 2011, pp.32, 5~31
- 신보문, "The Implementation and Effects of a Clinical Laboratory Accreditation Program in Korea from 1999 to 2006", Annals of Laboratory Medicine, 29(2), pp.163~170 (2009), 대한진단검사의학회
- Greaves RF, "Recent advances in the clinical application of mass spectrometry", EJIFCC, 27, pp.264~271 (2016)
- "Newborn Screening Quality Assurance Program 2018 Quailty Control Report" (2018)[URL]
- Al-Jenoobi FI, "Quantification of immunosuppressant’s in blood using LC-MS", MS, 2016, pp.3, 1039~
- Couchman L, "Variability in the analysis of 25-hydroxyvitamin D by liquid chromatography-tandem mass spectrometry : the devil is in the detail", Clin Chim Acta, 413, pp.1239~1243 (2012)
- Marney LC, "Isopropanol protein precipitation for the analysis of plasma free metanephrines by liquid chromatography-tandem mass spectrometry", Clin Chem, 54, pp.1729~1732 (2008)
- CLSI, "Liquid chromatography-mass spectrometry methods; approved guideline. CLSI C62-A", Clinical and Laboratory Standards Institute, ~ (2014)
- Valbuena H, "Comparing the effect of isotopically labeled or structural analog internal standards on the performance of a LC-MS", MS method to determine ciclosporin A, everolimus, sirolimus and tacrolimus in whole blood, 2016, pp.54, 437~446
- Buchwald A, "Validation of an LC-MS", MS method to determine five immunosuppressants with deuterated internal standards including MPA, 2012, pp.12, 2~
- "Guidance for industry: bioanalytical method validation" (2018)[URL]
- "Guideline on bioanalytical method validation" (2011)[URL]
- Scientific Working Group for Forensic Toxicology, "Scientific Working Group for Forensic Toxicology(SWGTOX)standard practices for method validation in forensic toxicology", J Anal Toxicol, 37, pp.452~474 (2013)