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Automated LC-MS/MS: Ready for the clinical routine Laboratory?
Sina Junger1, Miriam Hoene2, Maria Shipkova1
1SYNLAB MVZ Leinfelden-Echterdingen GmbH, Leinfelden-Echterdingen, Germany.
Journal of Mass Spectrometry and Advances in the Clinical Lab
|August 16, 2023
Summary
A fully automated liquid chromatography-tandem mass spectrometry (LC-MS/MS) system demonstrates high precision and accuracy for vitamin D and immunosuppressant drug testing. This automated LC-MS/MS is suitable for routine diagnostics in commercial laboratories.
Area of Science:
- Clinical Chemistry
- Analytical Chemistry
- Mass Spectrometry
Background:
- Liquid chromatography-tandem mass spectrometry (LC-MS/MS) offers high sensitivity and specificity for clinical diagnostics.
- Routine clinical laboratory use of LC-MS/MS is limited by complexity and lack of automation.
- Previous studies showed excellent performance of automated LC-MS/MS in hospital settings.
Purpose of the Study:
- To evaluate the suitability of a fully automated LC-MS/MS system in a commercial laboratory setting.
- To assess the usability of the automated LC-MS/MS system by diverse laboratory operators.
- To compare the performance of the automated system with existing methods in a commercial laboratory.
Main Methods:
- Analytical performance of the automated LC-MS/MS was assessed over five months for 25-hydroxy vitamin D and immunosuppressant drugs (ISDs).
- Assay results were compared against an identical analyzer in a hospital laboratory, in-house LC-MS/MS methods, and chemiluminescent microparticle immunoassays (CMIA).
- Nine operators evaluated system usability via a structured questionnaire.
Main Results:
- The automated system demonstrated high precision (CV < 8%) and accuracy (bias < 7%) with good agreement with external quality assessment samples.
- Results were comparable to an identical analyzer in a hospital laboratory.
- Acceptable median deviations were observed for 25-OH vitamin D3, cyclosporine A, and tacrolimus compared to in-house LC-MS/MS methods; bias was acceptable for 25-OH vitamin D3 versus immunoassays.
- All operators reported a positive user experience.
Conclusions:
- A fully automated LC-MS/MS system is well-suited for integration into routine diagnostics within commercial laboratories.
- The system's usability and analytical performance support its adoption in diverse laboratory environments.
- Automation addresses the complexity and enhances the routine application of LC-MS/MS in clinical diagnostics.
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