Clinical Trial: New Approaches for Evaluating the Interchangeability of Reference Materials and Quality Controls (COMET-MPL)

U.S., Sept. 16 -- ClinicalTrials.gov registry received information related to the study (NCT07173114) titled 'New Approaches for Evaluating the Interchangeability of Reference Materials and Quality Controls (COMET-MPL)' on Sept. 01.

Brief Summary: Medical biology tests are essential to clinical decision-making. The European Regulation on in vitro diagnostic medical devices (EU/2017/746) requires metrological traceability of the values assigned to calibrators and quality controls, based on reference measurement methods (RMMs) or certified reference materials (CRMs). However, these references are not available for all analyses, limiting manufacturers' ability to comply with regulatory requirements.

The dissemination of traceability relies m...