Guidelines for characterization and qualification of commutable reference materials for laboratory medicine

10 October 2008

The Clinical and Laboratory Standards Institute (CLSI) has recently published a new document, Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine; Proposed Guideline (C53-P). The comprehensive guideline 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.

Reference materials are an important requisite for assuring reliable laboratory measurements and appropriate patient care. To ensure that a reference material is suitable for its intended purpose, its commutability characteristics need to be assessed in a defined manner considering all relevant aspects.

Hubert Vesper, PhD, Centers for Disease Control and Prevention, and chairholder of the subcommittee that developed the guideline, says, “This document helps create better reference materials and therefore, aids in the improvement of assay calibration and standardization of clinical laboratory measurements. Standardized laboratory measurements are the basis of evidence-based medicine. This document makes an important contribution in patient care and disease prevention and control by helping create more reliable standardized laboratory measurements.”

Topics addressed in the guideline include:

  • qualification requirements of reference materials related to the definition of the measurand;
  • intended use of the material and other material specifications;
  • information on study designs, data evaluation, and uncertainty assessment;
  • revised definition of the term ‘commutability’; and
  • how to perform commutability evaluation.

For further information see 

Bookmark this page  Reddit  StumbleUpon

To top