CLSI EP30

Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine, 1st Edition

This document provides information to help material manufacturers in the production and characterization of commutable reference materials as well as assist assay manufacturers, proficiency testing providers, and laboratorians in the appropriate use of these materials for calibration and trueness assessment of in vitro diagnostic medical devices.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of April 2016. The document’s next scheduled review is generally five years after the reaffirmation date.

This document is available in electronic format only.

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Chairholder: Hubert Vesper, PhD

Date of Publication: May 28, 2010

Order Code PDF: CLSI EP30AE
ISBN Number: 1-56238-726-X

Order Code Print: print not available

Edition: First

Pages: 76

CLSI EP30 Additional Details

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This document was formerly sold under the code C53.

CLSI EP30 Abstract

Reference materials are an important requisite for ensuring reliable laboratory measurements and, thus, appropriate patient care. To ensure that a reference material is suitable for its intended purpose, its characteristics need to be assessed in a defined manner, taking all relevant aspects into consideration. This document provides information to help material manufacturers in the production and characterization of commutable reference materials, as well as assist assay manufacturers and laboratorians in the appropriate use of these materials for calibration and trueness assessment of in vitro diagnostic medical devices. Guidance on qualification requirements of reference materials related to the definition of the measurand, the intended use of the material, and other material specifications is provided. Information on study designs, data evaluation, and uncertainty assessment is included that is supplemental to existing guidance documents about the assessment of homogeneity, stability, and property values. This document provides a revised definition of the term commutability and provides guidance on how to perform commutability evaluation.