Using EP14: Evaluation of Commutability of Processed Samples

Recorded On: 09/27/2022

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September 27, 1:00 PM US Eastern time

Learn how to use the 4th edition of EP14--Evaluation of Commutability of Processed Samples. EP14 provides guidance for evaluating the commutability of processed samples for determining if they behave differently than unprocessed patient samples when two quantitative measurement procedures are compared.

Learning Objectives:

Understanding commutability
Determine which type of processed samples may need to be evaluated for commutability
How to design the commutability evaluation study, including acceptance criteria
Running the study, then reviewing the results to see if data transformations are needed
Analyzing the data and evaluating commutability

Speaker: Jeffrey R. Budd, PhD

Jeffrey R. Budd, PhD

Dr. Budd received his PhD in Biometry and Health Information Systems from the University of Minnesota. His entire career has been directed toward improving clinical diagnostics in lung function, cardiac electrophysiology, home health monitoring and finally in vitro diagnostics (IVD). He was Principal Biostatistician at Beckman Coulter for 20 years from which he retired 2 years ago.

Besides an IVD biostatistical consulting practice, Dr. Budd actively participates in developing IVD international guidelines. This includes membership in the ISO TC212 working group 2 which published 17511 on metrological traceability and the IFCC working group on reference material commutability which published a series of papers on this topic. He also plays active roles in CLSI including as a member of the EP Expert Panel; as chair of the document development committees (DDC) for EP09 on measurement procedure comparison, EP12 on qualitative examinations and EP30 on commutable reference material; and as member of the DDCs for EP14 on processed sample commutability and for EP32 on metrological traceability.