Nuances of Mass Spectrometry Method Validation
Lunch and Learn Industrial Workshop; Tuesday 12:45 - 1:45
Track 2: Harbor Ballroom
Dr. Annesley is Professor of Clinical Chemistry at the University of Michigan. He has held numerous elected offices within the AACC, and has also been a member of the editorial boards of multiple medical journals. He currently is the Deputy Editor of Clinical Chemistry. His interests include mass spectrometry and teaching biomedical writing. He is the author of the “Clinical Chemistry Guide to Scientific Writing” educational series.

Since most mass spectrometric assays are developed in-house, the clinical laboratory must perform and document the required validation of assay performance. This includes linearity, dilution protocols, imprecision, limit of quantification, recovery, interference checks, and often the preparation and assignment of calibrators and controls. Matrix effects, internal standard selection, and day-to-day instrument performance can have an impact on the imprecision, limit of quantification, and accuracy of an assay. This presentation will help attendees to consider the special nuances of mass spectrometric (and in-house developed) assays when bringing these assays in-house.