= Discovery stage.
= Translation stage.
= Clinically available.
MSACL 2018 EU : Keevil

MSACL 2018 EU Abstract

Self-Classified Topic Area(s): Practical Training

EU LC-MS Verification

Brian Keevil
Manchester University


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 Brian Keevil (Presenter)
Manchester University

Relevant Financial Disclosures (within past 24 months, reported on Mar 19, 2021)
No relevant financial relationship(s) to disclose.

Abstract

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.