MOLECULAR DIAGNOSTICS :: MASS SPECTROMETRY tion for routine clinical usage.12


In addi-


tion, with fully automated, total-solution LC-MS/MS clinical analyzers coming into the picture, it will open the door for new acquisition options such as reagent rental or cost per reportable result (CPRR), which will further facilitate clinical LC-MS/ MS adoption. And, in some cases both fully automated, closed systems and the current existing systems for esoteric and low-volume LDTs may be offered under a single, combined CPRR arrangement, further enabling optimization. Technological advancements in the


available options for clinical mass spec- trometry are progressing at a rapid pace. Leveraging the continuum of LC-MS/MS technologies (open systems for LDTs, in- cluding Class I medical devices and fully automated Class II IVD analyzer systems) will be the path forward for expansion and optimization of this powerful mea- surement technology for the clinical lab.


REFERENCES


1. Hammett-Stabler, et. al., The Evolution of Mass Spectrometry in the Clinical Laboratory, Clinical Applications of Mass Spectrometry, Methods in Molecular Biology 603, Chapter 1, Humana Press, 2010.


2. Vogesor, et. al., Progress in automation of LC-MS in laboratory medicine, Clinical Biochemistry, 44 (2011) 4-13.


3. Freeman et al. Performance evaluation of four 25-hydroxyvitamin D assays to measure 25-hydroxyvi- tamin D2. Clin Biochem. 2015; 48(16–17):1097-1104.


4. Tolan et al. Price of High-Throughput 25-Hydroxyvitamin D Immunoassays: Frequency of Inaccurate Results. J App Lab Med. 2018; 2(6): 868-879.


5. Erdman et al. Accuracy-Based Vitamin D Survey: Six Years of Quality Improvement Guided by Profi- ciency Testing. Arch Path Lab Med. 2019; 143(12): 1531-1538.


6. Bailey et al. Analytical measurement and clinical relevance of vitamin D3 C3-epimer. Clin Biochem. 2013; 46(3): 190-196.


7. Singh et al. C-3 Epimers Can Account for a Sig- nificant Proportion of Total Circulating 25-Hydroxyvi- tamin D in Infants, Complicating Accurate Measure- ment and Interpretation of Vitamin D Status. J Clin Endocrinol Metab. 2006; 91(8): 3055-3061.


8. Cashman et al. Significance of Serum 24,25-Dihy- droxyvitamin D in the Assessment of Vitamin D Status: A Double-edged Sword? Clin Chem 2015; 61(4): 636-645.


9. Bosworth et al. The serum 24, 25-dihydroxyvita- min D concentration, a marker of vitamin D catabo- lism, is reduced in chronic kidney disease. Kidney Int 2012; 82: 693-700.


10. Pierre Wallemacq, et. al. Assuring the Proper Analytical Performance of Measurement Proce- dures for Immunosuppressive Drug Concentra- tions in Clinical Practice: Recommendations of


the International Association of Therapeutic Drug Monitoring and Clinical Toxicology Immunosup- pressive Drug Scientific Committee, Ther Drug Monit, Vol 00, Number 00, Month 2016.


11. Alan Wu, Deborah French, et. al., Implementa- tion of liquid chromatography/mass spectrometry into the clinical laboratory, Clinica Chemica Acta 420 (2013) 4-10.


12. Yan Victoria Zhang and Alan Rockwood, Impact of automation on mass spectrometry, Clinica Chimica Acta, 450 (2015) 298 – 303.


13. Kimberly Scott, The Road to Automation in Clinical Mass Spectrometry, Clinical Laboratory News (CLN), September 2020, pgs. 12 – 14.


14. The benefits of lab automation to facilitate test- ing for SARS-CoV-2, Jamie Gramz, BSE, MBA, MLO, December 2020.


15. Minimizing laboratory errors with automation, By Jacqui Reithel, MBA, MT (ASCP), MLO, August 2021.


Mikko Salonen, System R&D Director, Clinical Mass Spectrometry, Thermo Fisher Scientific.


Peter Cooke, Americas Regional Marketing Manager, Clinical Mass Spectrometry, Thermo Fisher Scientific.


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