Roland Geyer (Presenter)
University Institute of Clinical Chemistry, Inselspital, Bern University Hospital, University of Bern, Switzerland
Authorship: (1) Roland Geyer (2) Judith Stone
(1) University Institute of Clinical Chemistry, Inselspital, Bern University Hospital, University of Bern, Switzerland (2) Univ. of Calif. San Diego Center for Advanced Laboratory Medicine
In this practical training session we will present an overview of guidelines and recommendations for quality assurance (QA) in clinical laboratories and discuss a range of examples that are specific for the routine use of liquid-chromatography mass spectrometry (LC-MS) methods. LC-MS methods have the advantage of providing, besides the analyte concentration value, a range of additional metadata that are useful and easy to evaluate. Appropriate use of metadata can help to improve the quality of the laboratory service. As we ensure and improve the intra- and inter-lab reproducibility of results, Mass Spectrometry is moving closer to fulfilling it’s potential as a gold standard for measuring the true concentration of analytes in routine clinical applications.
Mass Spectrometry based methods are considered to be the gold standard for determining the quantitative amount of compounds in biological specimens. Reasons for Mass Spectrometry (coupled with LC or GC) being able to produce accurate, specific and reproducible results are its ability to detect a compound (and characteristic fragments of a compound) directly, at high sensitivity and selectivity. Monoisotopic mass(es) are detected together with other parameters that are characteristic for the respective analyte (e.g. retention time, ion ratio). However, MS analysis can be hampered by many factors, all the way along from sample collection to final reporting of determined values. This can cause outliers in quality controls, random or systematic occurrence of odd values and poor inter-day or inter-lab reproducibility.
During method development and validation we usually gain an in-depth knowledge about such factors and their degree of influence (matrix effects, pipetting reproducibility, quality or shelf life of standards or control materials, etc.). This knowledge can be used to determine “acceptable ranges/tolerances” for routine application, to implement ‘flags/warnings’ in the results evaluation and reporting, and to provide guidelines for troubleshooting/evaluating the underlying reason(s) for outliers or drifts in results. It is also a base for scheduling routine instrument maintenance, monitoring instrument performance and any changes in consumable materials (lot numbers, dates, etc.).
Doing so, we proactively address potential issues in the routine use of our method(s) to prevent mistakes or failures and to avoid problems in the delivery of results/service to our customers. This is the aim of quality assurance (QA) and an important part of a quality management system in the clinical laboratory.
In this practical training session we will provide an overview on guidelines and recommendations for QA in clinical laboratories and discuss a range of examples that are specific for the routine use of mass spectrometry. LC-MS has the advantage of generating a range of additional information (metadata), besides the analyte concentration value, that are useful to monitor and can help to improve the quality of the laboratory service.
Conclusions & Discussion
As we ensure and improve the intra- and inter-lab reproducibility of results, Mass Spectrometry is getting closer to fulfilling it’s potential as a gold standard for measuring the true concentration of analytes in routine clinical applications.
References & Acknowledgements:
IP Royalty: no
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