Lab Med Online.  2020 Jan;10(1):1-9. 10.3343/lmo.2020.10.1.1.

Recommendations for the Use of Liquid Chromatography-Mass Spectrometry in the Clinical Laboratory: Part I. Implementation and Management

Affiliations
  • 1Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul, National University Bundang Hospital, Seongnam, Korea.
  • 2Department of Laboratory Medicine, Pusan National University Hospital, Busan, Korea.
  • 3Department of Laboratory Medicine, Green Cross Laboratories, Yongin, Korea.
  • 4Department of Laboratory Medicine, Chonnam National University Medical School, Gwangju, Korea.
  • 5Department of Laboratory Medicine, Yonsei University College of Medicine, Seoul, Korea.
  • 6Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
  • 7Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea. cloak21@snu.ac.kr

Abstract

Many types of assays involving mass spectrometry have been developed and applied in clinics. However, mass spectrometry has not been widely implemented yet relative to other measurement methods, including biochemical assays, immunoassays, and molecular diagnostics. Despite its strong advantage as an analytical method, many laboratory physicians and clinical laboratories are unwilling to introduce it. Fundamental elements, such as instruments, reagents, facilities, skilled human resources are required to implement mass spectrometry. This review contains considerations for the introduction of liquid chromatography-mass spectrometry to support the clinical laboratories interested in or planning to implement mass spectrometry.

Keyword

Liquid chromatography-mass spectrometry (LC-MS); Clinical laboratory; Mass spectrometric assay

MeSH Terms

Humans
Immunoassay
Indicators and Reagents
Mass Spectrometry
Methods
Pathology, Molecular
Spectrum Analysis*
Indicators and Reagents

Reference

1. Jannetto PJ, Fitzgerald RL. Effective use of mass spectrometry in the clinical laboratory. Clin Chem. 2016; 62:92–98.
Article
2. Moon SY, Lim MK, Hong S, Jeon Y, Han M, Song SH, et al. Quantification of human plasma-busulfan concentration by liquid chromatography-tandem mass spectrometry. Ann Lab Med. 2014; 34:7–14.
Article
3. Song SH, Jun SH, Park KU, Yoon Y, Lee JH, Kim JQ, et al. Simultaneous determination of first-line anti-tuberculosis drugs and their major metabolic ratios by liquid chromatography/tandem mass spectrometry. Rapid Commun Mass Spectrom. 2007; 21:1331–1338.
Article
4. Han M, Jun SH, Lee JH, Park KU, Song J, Song SH. Method for simultaneous analysis of nine second-line anti-tuberculosis drugs using UPLC-MS/MS. J Antimicrob Chemother. 2013; 68:2066–2073.
Article
5. Taylor PJ. Therapeutic drug monitoring of immunosuppressant drugs by high-performance liquid chromatography-mass spectrometry. Ther Drug Monit. 2004; 26:215–219.
Article
6. Clarke NJ, Zhang Y, Reitz RE. A novel mass spectrometry-based assay for the accurate measurement of thyroglobulin from patient samples containing antithyroglobulin autoantibodies. J Investig Med. 2012; 60:1157–1163.
Article
7. Kushnir MM, Rockwood AL, Roberts WL, Abraham D, Hoofnagle AN, Meikle AW. Measurement of thyroglobulin by liquid chromatography-tandem mass spectrometry in serum and plasma in the presence of antithyroglobulin autoantibodies. Clin Chem. 2013; 59:982–990.
Article
8. Millington DS, Kodo N, Norwood DL, Roe CR. Tandem mass spectro-metry: a new method for acylcarnitine profiling with potential for neonatal screening for inborn errors of metabolism. J Inherit Metab Dis. 1990; 13:321–324.
Article
9. Rashed MS, Bucknall MP, Little D, Awad A, Jacob M, Alamoudi M, et al. Screening blood spots for inborn errors of metabolism by electrospray tandem mass spectrometry with a microplate batch process and a computer algorithm for automated flagging of abnormal profiles. Clin Chem. 1997; 43:1129–1141.
Article
10. Murphy RC, Gaskell SJ. New applications of mass spectrometry in lipid analysis. J Biol Chem. 2011; 286:25427–25433.
Article
11. Chae H, Cho SE, Park HD, Chun S, Lee YW, Yun YM, et al. Use of liquid chromatography-tandem mass spectrometry for clinical testing in Korean laboratories: a questionnaire survey. Ann Lab Med. 2019; 39:447–453.
Article
12. Moscato D, Nonnato A, Adamo R, Vancheri M, Caropreso A. Therapeutic monitoring of tacrolimus: aberrant results by an immunoassay with automated pretreatment. Clin Chim Acta. 2010; 411:77–80.
Article
13. Rostaing L, Cointault O, Marquet P, Josse AG, Lavit M, Saint-Marcoux F, et al. Falsely elevated whole-blood tacrolimus concentrations in a kidney-transplant patient: potential hazards. Transpl Int. 2010; 23:227–230.
Article
14. Kuhn J, Knabbe C. Fully validated method for rapid and simultaneous measurement of six antiepileptic drugs in serum and plasma using ultra-performance liquid chromatography-electrospray ionization tandem mass spectrometry. Talanta. 2013; 110:71–80.
Article
15. Juenke JM, Brown PI, Johnson-Davis KL, McMillin GA. Simultaneous quantification of levetiracetam and gabapentin in plasma by ultra-pressure liquid chromatography coupled with tandem mass spectrometry detection. Ther Drug Monit. 2011; 33:209–213.
Article
16. Sotgiu G, Alffenaar JW, Centis R, D'Ambrosio L, Spanevello A, Piana A, et al. Therapeutic drug monitoring: how to improve drug dosage and patient safety in tuberculosis treatment. Int J Infect Dis. 2015; 32:101–104.
Article
17. Lee K, Jun SH, Han M, Song SH, Park JS, Lee JH, et al. Multiplex assay of second-line anti-tuberculosis drugs in dried blood spots using ultra-performance liquid chromatography-tandem mass spectrometry. Ann Lab Med. 2016; 36:489–493.
Article
18. Lee K, Jun SH, Choi MS, Song SH, Park JS, Lee JH, et al. Application of the isoniazid assay in dried blood spots using the ultra-performance liquid chromatography-tandem mass spectrometry. Clin Biochem. 2017; 50:882–885.
Article
19. Gómez-López A, Cendejas-Bueno E, Cuesta I, García Rodríguez J, Rodríguez-Tudela JL, Gutiérrez-Altés A, et al. Voriconazole serum levels measured by high-performance liquid chromatography: a monocentric study in treated patients. Med Mycol. 2012; 50:439–445.
Article
20. Basu SS, Petrides A, Mason DS, Jarolim P. A rapid UPLC-MS/MS assay for the simultaneous measurement of fluconazole, voriconazole, posa-conazole, itraconazole, and hydroxyitraconazole concentrations in serum. Clin Chem Lab Med. 2017; 55:836–844.
Article
21. Jeon Y, Han M, Han EY, Lee K, Song J, Song SH. Performance evaluation of enzyme immunoassay for voriconazole therapeutic drug monitoring with automated clinical chemistry analyzers. Pract Lab Med. 2017; 8:86–94.
Article
22. Gobin P, Lemaître F, Marchand S, Couet W, Olivier JC. Assay of colistin and colistin methanesulfonate in plasma and urine by liquid chromatography-tandem mass spectrometry. Antimicrob Agents Chemother. 2010; 54:1941–1948.
Article
23. Bihan K, Lu Q, Enjalbert M, Apparuit M, Langeron O, Rouby JJ, et al. Determination of colistin and colistimethate levels in human plasma and urine by high-performance liquid chromatography-tandem mass spectrometry. Ther Drug Monit. 2016; 38:796–803.
Article
24. Supreme Prosecutors' Office. Outline of narcotics. Narcotic crime white paper 2018. Seoul: Supreme Prosecutors' Office;2018. p. 18–53.
25. Act on the management of narcotic drugs. Amended by Act no. 15939. 2019. 03. 12. Last accessed on Nov. 2019. http://www.law.go.kr/lsInfoP.do?lsiSeq=205683#0000.
26. Spacil Z, Tatipaka H, Barcenas M, Scott CR, Turecek F, Gelb MH. High-throughput assay of 9 lysosomal enzymes for newborn screening. Clin Chem. 2013; 59:502–511.
Article
27. Ministry of Health and Welfare. Lysosomal storage disease screening test [high quality spectrometry/mass analysis]. Notice of assessment results on the safety and efficacy of new health technology. Amended by Notice no. 2019-243. Sejong: Ministry of Health and Welfare;2019. 11.
28. Kim B, Lee MN, Park HD, Kim JW, Chang YS, Park WS, et al. Dried blood spot testing for seven steroids using liquid chromatography-tandem mass spectrometry with reference interval determination in the Korean population. Ann Lab Med. 2015; 35:578–585.
Article
29. Becker S, Thiery J, Ceglarek U. Evaluation of a novel commercial assay for the determination of cyclosporine A, tacrolimus, sirolimus, and everolimus by liquid chromatography-tandem mass spectrometric assay. Ther Drug Monit. 2013; 35:129–132.
Article
30. Kim H, Sohn A, Yeo I, Yu SJ, Yoon JH, Kim Y. Clinical assay for AFP-L3 by using multiple reaction monitoring-mass spectrometry for diagnosing hepatocellular carcinoma. Clin Chem. 2018; 64:1230–1238.
Article
31. Sohn A, Kim H, Yu SJ, Yoon JH, Kim Y. A quantitative analytical method for PIVKA-II using multiple reaction monitoring-mass spectrometry for early diagnosis of hepatocellular carcinoma. Anal Bioanal Chem. 2017; 409:2829–2838.
Article
32. Ministry of Health and Welfare. Protein induced by vitamin K absence or antagonist-II (PIVKA-II) quantitative test [high quality spectrometry/ mass analysis]. Notice of assessment results on the safety and efficacy of new health technology. Amended by Notice no. 2019-232. Sejong: Ministry of Health and Welfare;2019.
33. The National Institute of Environmental Research. Operation management and safety of the environmental laboratory. Published no. 11-1480523-002398-01. Incheon: The National Institute of Environmental Research;2015.
34. Korea Occupational Safety and Health Agency. Technical guidance for laboratory safety and health. KOSHA GUIDE G-82-2018. Ulsan: Korea Occupational Safety and Health Agency;2018.
35. Dooley KC. Tandem mass spectrometry in the clinical chemistry laboratory. Clin Biochem. 2003; 36:471–481.
Article
36. Zhang YV, Rockwood A. Impact of automation on mass spectrometry. Clin Chim Acta. 2015; 450:298–303.
Article
Full Text Links
  • LMO
Actions
Cited
CITED
export Copy
Close
Share
  • Twitter
  • Facebook
Similar articles
Copyright © 2024 by Korean Association of Medical Journal Editors. All rights reserved.     E-mail: koreamed@kamje.or.kr