Ann Lab Med.  2019 Sep;39(5):447-453. 10.3343/alm.2019.39.5.447.

Use of Liquid Chromatography-Tandem Mass Spectrometry for Clinical Testing in Korean Laboratories: a Questionnaire Survey

• Chae H
• Cho SE
• Park HD
• Chun S
• Lee YW
• Yun YM
• Song SH
• Lee SG
• Lee K
• Song J
• Lee SY
• On behalf of the Clinical Mass Spectrometry Research Committee of Korean Society of Clinical Chemistry

• KMID: 2450967
• DOI: http://doi.org/10.3343/alm.2019.39.5.447

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.

Keyword

Liquid chromatography-tandem mass spectrometry; Korea; Survey; Harmonization

MeSH Terms

Chemistry, Clinical
Humans
Indicators and Reagents
Infant, Newborn
Korea
Mass Screening
Mass Spectrometry*
Metanephrine
Plasma
Tacrolimus
Vitamin D
Indicators and Reagents
Metanephrine
Tacrolimus
Vitamin D

Reference

1. Taylor PJ. High-performance liquid chromatography-mass spectrometry in the clinical laboratory. Ther Drug Monit. 2005; 27:689–693. PMID: 16404795.

2. Dooley KC. Tandem mass spectrometry in the clinical chemistry laboratory. Clin Biochem. 2003; 36:471–481. PMID: 12951172.

3. Grebe SK, Singh RJ. LC-MS/MS in the clinical laboratory–where to from here? Clin Biochem Rev. 2011; 32:5–31. PMID: 21451775.

4. Shin BM, Chae SL, Min WK, Lee WG, Lim YA, Lee DH, et al. The implementation and effects of a clinical laboratory accreditation program in Korea from 1999 to 2006. Korean J Lab Med. 2009; 29:163–170. PMID: 19411785.

5. Greaves RF. Recent advances in the clinical application of mass spectrometry. EJIFCC. 2016; 27:264–271. PMID: 28149261.

6. CDC. Newborn Screening Quality Assurance Program 2018 Quailty Control Report. Issued June 8, 2018. https://www.cdc.gov/labstandards/pdf/nsqap/nsqap_2018_qcset1_report.pdf.

7. Al-Jenoobi FI, Alam MA, Al-Mohizea AM. Quantification of immunosuppressant's in blood using LC-MS/MS. Austin Chromatogr. 2016; 3:1039.

8. Couchman L, Benton CM, Moniz CF. Variability in the analysis of 25-hydroxyvitamin D by liquid chromatography-tandem mass spectrometry: the devil is in the detail. Clin Chim Acta. 2012; 413:1239–1243. PMID: 22515958.

9. Marney LC, Laha TJ, Baird GS, Rainey PM, Hoofnagle AN. Isopropanol protein precipitation for the analysis of plasma free metanephrines by liquid chromatography-tandem mass spectrometry. Clin Chem. 2008; 54:1729–1732. PMID: 18687739.

10. CLSI. Liquid chromatography-mass spectrometry methods; approved guideline. CLSI C62-A. Wayne, PA: Clinical and Laboratory Standards Institute;2014.

11. Valbuena H, Shipkova M, Kliesch SM, Müller S, Wieland E. 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. Clin Chem Lab Med. 2016; 54:437–446. PMID: 26351941.

12. Buchwald A, Winkler K, Epting T. Validation of an LC-MS/MS method to determine five immunosuppressants with deuterated internal standards including MPA. BMC Clin Pharmacol. 2012; 12:2. PMID: 22236286.

13. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Veterinary Medicine. Guidance for industry: bioanalytical method validation. Updated on May 2018. https://www.fda.gov/downloads/drugs/guidances/ucm070107.pdf.

14. European Medicines Agency. Guideline on bioanalytical method validation. Updated on July 2011. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf.

15. Scientific Working Group for Forensic Toxicology. Scientific Working Group for Forensic Toxicology (SWGTOX) standard practices for method validation in forensic toxicology. J Anal Toxicol. 2013; 37:452–474. PMID: 23934984.