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

What this Trial Is About

Medical biology tests play a crucial role in clinical decision-making, requiring reliable and standardized results across medical laboratories. The European Regulation on in vitro diagnostic medical devices mandates metrological traceability for values assigned to calibrators and quality controls, relying on reference measurement methods or certified reference materials (CRMs). However, many analyses lack such references, limiting manufacturers' ability to meet regulatory standards and laboratories' compliance with ISO standards. The COMET-MPL project focuses on developing and evaluating commutable CRMs and external quality controls (EQA) that behave like native patient samples to ensure analytical validity. The project targets priority analyses such as bilirubin, cyclosporine, parathyroid hormone, human cytomegalovirus, and estradiol. These materials will be tested in French laboratories using automated high-throughput systems to assess their interchangeability and suitability as calibrators or quality controls. Participants will contribute by attending a single visit during a routine blood draw, where three blood tubes are collected. Serum samples will be aliquoted and sent to partner labs for analysis. Researchers will measure various serum concentrations and activities, including testosterone, calcium, glucose, cholesterol, and enzyme activities, to assess commutability. The study aims to improve patient care pathways, enhance regulatory compliance, and provide high-quality reference materials for more accurate laboratory testing.

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