Automated LC-MS/MS: Ready for the clinical routine Laboratory?
Background: Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is a sensitive method with high specificity. However, its routine use in the clinical laboratory is hampered by its high complexity and lack of automation. Studies demonstrate excellent analytical performance using the first fully...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2023-11-01
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| Series: | Journal of Mass Spectrometry and Advances in the Clinical Lab |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2667145X23000299 |
| _version_ | 1797394783659884544 |
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| author | Sina Junger Miriam Hoene Maria Shipkova Gudrun Danzl Christof Schöberl Andreas Peter Rainer Lehmann Eberhard Wieland Helmine Braitmaier |
| author_facet | Sina Junger Miriam Hoene Maria Shipkova Gudrun Danzl Christof Schöberl Andreas Peter Rainer Lehmann Eberhard Wieland Helmine Braitmaier |
| author_sort | Sina Junger |
| collection | DOAJ |
| description | Background: Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is a sensitive method with high specificity. However, its routine use in the clinical laboratory is hampered by its high complexity and lack of automation. Studies demonstrate excellent analytical performance using the first fully automated LC-MS/MS for 25-hydroxy vitamin D and immunosuppressant drugs (ISD) in hospital routine laboratories. Objectives: Our objectives were (1) to verify the suitability of an automated LC-MS/MS in a commercial laboratory, which differs from the needs of hospital laboratories, and (2) examine its usability among operators with various professional backgrounds. Methods: We assessed the analytical assay performance for vitamin D and the ISDs cyclosporine A and tacrolimus over five months. The assays were compared to an identical analyzer in a hospital laboratory, to in-house LC-MS/MS methods, and to chemiluminescent microparticle immunoassays (CMIA). Nine operators evaluated the usability of the fully automated LC-MS/MS system by means of a structured questionnaire. Results: The automated system exhibited a high precision (CV < 8%), accuracy (bias < 7%) and good agreement with concentrations of external quality assessment (EQA) samples. Comparable results were obtained with an identical analyzer in a hospital routine laboratory. Acceptable median deviations of results versus an in-house LC-MS/MS were observed for 25-OH vitamin D3 (-10.6%), cyclosporine A (-4.3%) and tacrolimus (-6.6%). The median bias between the automated system and immunoassays was only acceptable for 25-OH vitamin D3 (6.6%). All users stated that they had had a good experience with the fully automated LC-MS/MS system. Conclusions: A fully automated LC-MS/MS can be easily integrated for routine diagnostics in a commercial laboratory. |
| first_indexed | 2024-03-09T00:24:43Z |
| format | Article |
| id | doaj.art-de691191bc34456491b822f41217d248 |
| institution | Directory Open Access Journal |
| issn | 2667-145X |
| language | English |
| last_indexed | 2024-03-09T00:24:43Z |
| publishDate | 2023-11-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Journal of Mass Spectrometry and Advances in the Clinical Lab |
| spelling | doaj.art-de691191bc34456491b822f41217d2482023-12-12T04:36:48ZengElsevierJournal of Mass Spectrometry and Advances in the Clinical Lab2667-145X2023-11-013019Automated LC-MS/MS: Ready for the clinical routine Laboratory?Sina Junger0Miriam Hoene1Maria Shipkova2Gudrun Danzl3Christof Schöberl4Andreas Peter5Rainer Lehmann6Eberhard Wieland7Helmine Braitmaier8SYNLAB MVZ Leinfelden-Echterdingen GmbH, Leinfelden-Echterdingen, GermanyInstitute for Clinical Chemistry and Pathobiochemistry, Department for Diagnostic Laboratory Medicine, University Hospital Tübingen, Tübingen, GermanySYNLAB MVZ Leinfelden-Echterdingen GmbH, Leinfelden-Echterdingen, GermanySynlab MVZ Augsburg GmbH, Augsburg, GermanySYNLAB MVZ Leinfelden-Echterdingen GmbH, Leinfelden-Echterdingen, GermanyInstitute for Clinical Chemistry and Pathobiochemistry, Department for Diagnostic Laboratory Medicine, University Hospital Tübingen, Tübingen, GermanyInstitute for Clinical Chemistry and Pathobiochemistry, Department for Diagnostic Laboratory Medicine, University Hospital Tübingen, Tübingen, GermanySYNLAB MVZ Leinfelden-Echterdingen GmbH, Leinfelden-Echterdingen, GermanySYNLAB MVZ Leinfelden-Echterdingen GmbH, Leinfelden-Echterdingen, Germany; Corresponding author at: SYNLAB MVZ Leinfelden-Echterdingen GmbH, Nikolaus-Otto-Str. 6, 70771 Leinfelden-Echterdingen, Germany.Background: Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is a sensitive method with high specificity. However, its routine use in the clinical laboratory is hampered by its high complexity and lack of automation. Studies demonstrate excellent analytical performance using the first fully automated LC-MS/MS for 25-hydroxy vitamin D and immunosuppressant drugs (ISD) in hospital routine laboratories. Objectives: Our objectives were (1) to verify the suitability of an automated LC-MS/MS in a commercial laboratory, which differs from the needs of hospital laboratories, and (2) examine its usability among operators with various professional backgrounds. Methods: We assessed the analytical assay performance for vitamin D and the ISDs cyclosporine A and tacrolimus over five months. The assays were compared to an identical analyzer in a hospital laboratory, to in-house LC-MS/MS methods, and to chemiluminescent microparticle immunoassays (CMIA). Nine operators evaluated the usability of the fully automated LC-MS/MS system by means of a structured questionnaire. Results: The automated system exhibited a high precision (CV < 8%), accuracy (bias < 7%) and good agreement with concentrations of external quality assessment (EQA) samples. Comparable results were obtained with an identical analyzer in a hospital routine laboratory. Acceptable median deviations of results versus an in-house LC-MS/MS were observed for 25-OH vitamin D3 (-10.6%), cyclosporine A (-4.3%) and tacrolimus (-6.6%). The median bias between the automated system and immunoassays was only acceptable for 25-OH vitamin D3 (6.6%). All users stated that they had had a good experience with the fully automated LC-MS/MS system. Conclusions: A fully automated LC-MS/MS can be easily integrated for routine diagnostics in a commercial laboratory.http://www.sciencedirect.com/science/article/pii/S2667145X23000299AutomationCascadion analyzerCyclosporine ALC-MS/MSTacrolimusVitamin D |
| spellingShingle | Sina Junger Miriam Hoene Maria Shipkova Gudrun Danzl Christof Schöberl Andreas Peter Rainer Lehmann Eberhard Wieland Helmine Braitmaier Automated LC-MS/MS: Ready for the clinical routine Laboratory? Journal of Mass Spectrometry and Advances in the Clinical Lab Automation Cascadion analyzer Cyclosporine A LC-MS/MS Tacrolimus Vitamin D |
| title | Automated LC-MS/MS: Ready for the clinical routine Laboratory? |
| title_full | Automated LC-MS/MS: Ready for the clinical routine Laboratory? |
| title_fullStr | Automated LC-MS/MS: Ready for the clinical routine Laboratory? |
| title_full_unstemmed | Automated LC-MS/MS: Ready for the clinical routine Laboratory? |
| title_short | Automated LC-MS/MS: Ready for the clinical routine Laboratory? |
| title_sort | automated lc ms ms ready for the clinical routine laboratory |
| topic | Automation Cascadion analyzer Cyclosporine A LC-MS/MS Tacrolimus Vitamin D |
| url | http://www.sciencedirect.com/science/article/pii/S2667145X23000299 |
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