Is your laboratory under pressure to purchase an LC-tandem MS or is the ROI you wrote last year haunting you now? This short course is designed for attendees implementing quantitative LC-tandem MS for patient testing who have laboratory medicine experience but no mass spectrometry training - CLS bench analysts, supervisors, R&D scientists, and laboratory directors. Theoretical concepts necessary for a robust implementation of clinical mass spectrometry will be presented - but the emphasis is on practical recommendations for: 1. LC-MS/MS system purchasing, 2. site preparation and installation, 3. defining preliminary MSMS and LC parameters for your first method, 4. selecting and optimizing sample preparation for your first method, 5. choosing internal standards, solvents, and water, making reagents and calibrators, 6. adjusting sample preparation, LC and MSMS parameters to achieve the desired assay performance, 7. establishing data analysis & batch review criteria, 8. pre-validation stress testing and method validation, 9. preventative maintenance and troubleshooting, 10. maintaining quality in production.
Our goal is to present just enough theory so you can report high quality results, while opening a window to the depth and complexity of clinical mass spectrometry such that your appetite is whetted to learn more. The IFCC Committee for Distance Learning published a curriculum guideline for post-graduate trainees in laboratory medicine in 2017. This course includes all of the IFCC mass spectrometry curriculum listed in the "Principles of Analysis X-MS" section, except that we focus only on triple quadrupole mass spectrometry; metabolomics, proteomics and inborn errors of metabolism are not discussed.
Previous exposure to the principles of clinical method validation, either didactic or practical, is assumed.