EU LC-MS Verification Brian Keevil (Presenter) Manchester University

Authors: Brian Keevil
Manchester University

The new EU regulations for the use of diagnostic kits will soon come into force. How will this affect laboratories and how will the laboratories verify the results produced by these kits? The UKAS standard used in UK laboratories (ISO 15189) is not prescriptive, it tells us what we should be doing, but not how to do it. To help us in this there are many guidelines for the validation /verification of kits. However, some of these guidelines are more prescriptive than others and give greater detail on what needs to be done. The talks will focus on the techniques used locally to validate and monitor LC-MS assays and verify currently available diagnostic kits.

Overview

The new EU regulations for the use of diagnostic kits will soon come into force. How will this affect laboratories and how will the laboratories verify the results produced by these kits? The UKAS standard used in UK laboratories (ISO 15189) is not prescriptive, it tells us what we should be doing, but not how to do it. To help us in this there are many guidelines for the validation /verification of kits. However, some of these guidelines are more prescriptive than others and give greater detail on what needs to be done. The talks will focus on the techniques used locally to validate and monitor LC-MS assays and verify currently available diagnostic kits.

In short, we need to know what constitutes a kit, what the manufacturer claims about kit performance and what needs to be or can be verified in the kit. Common metrics for kit validation will be discussed including metrological traceability, ion suppression, ion ratios, sample stability, reference ranges, imprecision, accuracy, recovery, measurement range, measurement uncertainty and specificity. How the verification is documented in the laboratory quality management system will be also be discussed.