WAYNE, PA--(Marketwire - June 09, 2010) -
Clinical and Laboratory Standards Institute (CLSI) recently published a new document, "Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine; Approved Guideline" (C53-A). Reference materials are an important requisite for ensuring 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. The guideline particularly addresses the assessment of commutability and the statistical evaluation of commutability data. Standardized laboratory measurements are the basis of evidence-based medicine. This document makes an important contribution to patient care and disease prevention and control by helping create more reliable standardized laboratory measurements."
The comprehensive guideline provides information to help reference 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.
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
- Statistical approaches and background information for performing commutability evaluation
CLSI is a volunteer-driven, membership-supported, nonprofit organization dedicated to developing standards and guidelines for the health care and medical testing community through a consensus process that balances the perspectives of industry, government, and the health care professions. For additional information on CLSI, visit the CLSI website at www.clsi.org or call 610.688.0100.