CLSI EP30
Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine, 2nd Edition
CLSI EP30 provides information to help material manufacturers in the production and characterization of commutable reference materials.
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Chairholder: Jeffrey R. Budd, PhD; Alicia Lyle
Date of Publication: August 1, 2024
Order Code PDF: CLSI EP30Ed2E
ISBN Number: 978-1-68440-243-4
Order Code Print: CLSI EP30Ed2
ISBN Number: 978-1-68440-242-7
Edition: Second
Pages: 110
CLSI EP30 Additional Details
A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.
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CLSI EP30 Abstract
Clinical and Laboratory Standards Institute EP30—Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine provides guidance on characterizing and qualifying the fitness for use of commutable reference material (RM) as either a common calibrator or a trueness control for multiple measurement procedures.
This guideline covers RM qualification requirements, characterization of homogeneity and stability, the assignment of quantity values, and determining RM value uncertainties. Three approaches for assessing commutability of RM are provided along with worked examples. Recommendations are made on how to report the results of the RM qualification process.