Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine; Approved Guideline
|Publication Date:||1 May 2010|
This guideline provides recommendations for the characterization, assessment of commutability, and assignment of analyte concentration or activity values to reference materials (RMs) that are used for calibration and trueness assessment of in vitro diagnostic medical devices. This includes materials such as the following:
- Certified reference materials (CRMs)
- Materials without a formal certificate but with the characteristics of a CRM and attached information sufficient for use in instrument calibration or trueness control (eg, external quality assessment [EQA] or proficiency testing [PT] materials used to assess trueness)
This guideline is not intended to be applied to materials used to assess consistency of peer groups based on target values determined from participant results in EQA/PT or interlaboratory quality control programs, control materials used for routine (field) methods, manufacturer's product-specific calibrators, or noncommutable secondary RMs.
The document integrates existing standards and guidelines with new recommendations. References to existing documents addressing certain aspects of material characterization and assignment of values are provided, and new recommendations for assessment of commutability and value transfer procedures are described.
This document provides information to assist RM manufacturers in the production and characterization of materials, and to assist users of these materials, such as test system manufacturers, EQA or PT providers, and laboratorians, to assess the applicability of a material for a specific measurement procedure or clinical application.