Evaluation of the 25-hydroxy vitamin D assay on a fully automated liquid chromatography mass spectrometry system, the Thermo Scientific Cascadion SM Clinical Analyzer with the Cascadion 25-hydroxy vitamin D assay in a routine clinical laboratory
-
Sally C. Benton
,
Godwin K. Tetteh
Abstract
Background
Liquid chromatography-tandem mass spectrometry (LC-MS/MS) offers advantages over immunoassay due to its increased specificity and ability to multiplex metabolites within a single run. Wide scale adoption of LC-MS/MS in routine clinical laboratories is restricted in part due to the high level of technical expertise required. The Thermo Scientific™ Cascadion™ SM Clinical Analyzer is the first fully automated, random access clinical analyser that utilises LC-MS/MS technology. We report an analytical validation of the 25-hydroxy vitamin D2 and D3 assays on the Cascadion Analyzer and an assessment of its performance within a routine clinical laboratory.
Methods
Analyser usability was assessed by staff with no previous experience of LC-MS/MS. An analytical validation included analysis of 154 patient samples on two different Cascadion Analyzers and a four-way method comparison of 146 patient samples on Roche and Siemens immunoassays and an in-house LC-MS/MS method. Accuracy was assessed using external quality assurance and reference materials. Seven third party IQC materials were tested on Cascadion.
Results
Cascadion proved easy to use by scientific and non-scientific staff. The assay passed all validation criteria. Excellent agreement was demonstrated between two different Cascadions (y = 0.97x + 3.9 nmol/L, r2 > 0.99). A method comparison demonstrated no significant difference (p > 0.05) between the Cascadion and the Roche immunoassay. A significant difference (p < 0.0001) was observed between the Cascadion and an LC-MS/MS and Siemens methods. Results obtained from EQA and reference material showed a mean bias of +3.09% and all samples were within ±10% of assigned concentrations. All third party IQC samples tested were compatible for use with Cascadion.
Conclusions
The Cascadion Analyzer is a fully automated LC-MS/MS system that requires no prior LC-MS/MS expertise. The vitamin D assays demonstrated excellent performance with high levels of accuracy.
Acknowledgments
The authors acknowledge the opportunity provided by Thermo Fisher Scientific to be involved in this exciting project. We acknowledge the support of their entire global team throughout the duration of the study with special thanks to Jouni Sallinen for his scientific input.
Author contribution: Sally C. Benton was the project lead for the Frimley laboratory and has drafted the manuscript with Anna M. Milan. Godwin K. Tetteh and Sarah-Jayne Needham were the key operators at the Frimley laboratory and Jakob Mücke at the AG Viollier laboratory. All authors have reviewed and contributed to the manuscript. All authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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©2019 Walter de Gruyter GmbH, Berlin/Boston
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Articles in the same Issue
- Frontmatter
- Editorial
- Advancements in mass spectrometry as a tool for clinical analysis: part II
- Quantitative protein assessment
- Complexity, cost, and content – three important factors for translation of clinical protein mass spectrometry tests, and the case for apolipoprotein C-III proteoform testing
- Vedolizumab quantitation using high-resolution accurate mass-mass spectrometry middle-up protein subunit: method validation
- Development and evaluation of an element-tagged immunoassay coupled with inductively coupled plasma mass spectrometry detection: can we apply the new assay in the clinical laboratory?
- MALDI-MS for the clinic
- Matrix-assisted laser desorption ionisation (MALDI) mass spectrometry (MS): basics and clinical applications
- Clinical use of mass spectrometry (imaging) for hard tissue analysis in abnormal fracture healing
- Cellular resolution in clinical MALDI mass spectrometry imaging: the latest advancements and current challenges
- Bacterial identification by lipid profiling using liquid atmospheric pressure matrix-assisted laser desorption/ionization mass spectrometry
- Clinical application of ’omics technologies
- Individualized metabolomics: opportunities and challenges
- Diagnostic amyloid proteomics: experience of the UK National Amyloidosis Centre
- The “olfactory fingerprint”: can diagnostics be improved by combining canine and digital noses?
- Peptidomic and proteomic analysis of stool for diagnosing IBD and deciphering disease pathogenesis
- The influence of hypoxia on the prostate cancer proteome
- Laboratory automation and kit-based approaches
- Mass spectrometry and total laboratory automation: opportunities and drawbacks
- The pathway through LC-MS method development: in-house or ready-to-use kit-based methods?
- Evaluation of the 25-hydroxy vitamin D assay on a fully automated liquid chromatography mass spectrometry system, the Thermo Scientific Cascadion SM Clinical Analyzer with the Cascadion 25-hydroxy vitamin D assay in a routine clinical laboratory
