Assessing the Quality and Robustness of LC-MS/MS Assays
James Hawley University Hospital NHS Foundation Trust
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James Hawley (Presenter) Manchester University NHS Foundation Trust
Presenter Bio: I trained as a Clinical Scientist at University Hospital Coventry, UK. After completing my training I re-located to Manchester, UK to work alongside Prof. Brian Keevil at Wythenshawe Hospital. During my time at Wythenshawe I have specialised in clinical mass spectrometry and have developed and validated a number of assays. I have a keen interest in different approaches to sample preparation and steroid hormone quantitation.
Relevant Financial Disclosures
(within past 24 months)
No relevant financial relationship(s) to disclose.
Abstract
Here I will be presenting three tracks that will hopefully help new users improve the quality and robustness of their assays.
During the first track I will discuss identifying and troubleshooting poor chromatography, peak integration and the use of techniques to help identify potential interferences and thus improve the confidence in results.
The second track will concentrate on strategies that can be used to help assess method robustness. Here I will look to highlight the importance of all the data that is available aside from the final result. We will cover what data can be routinely recorded (e.g. top standard areas/heights, retention times, peak widths etc) and why that may be useful in helping troubleshoot assays and identify issues.
The third track will address reagent control, specifically aimed at a implementing and managing a system that is ISO 15189 compliant. I will discuss acceptance testing of reagents including calibrators, QCs, internal standards, routine mobile phases and any reagent used in sample preparation
By the end of the session you should have improved ability to identify and troubleshoot problems, understand how data can be used to assess assay robustness and be able to implement and manage a ISO 15189 compliant reagent control system.
= Discovery stage.
= Translation stage.
= Clinically available.
