Lecture
The COMET project: Towards commutable materials for use in external quality assessment and to produce certified reference materials
- at -
- ICM Saal 4a
- Type: Lecture
Lecture description
Medical decisions often depend on accurate, informative and comparable biomarker measurement results from commercial in vitro diagnostic (IVD) tests. According to the in vitro diagnostic regulation (IVDR) EU/2017/746, the metrological traceability of values assigned to calibrators and/or control materials shall be assured through suitable reference measurement procedures (RMPs) and/or suitable Certified Reference Materials (CRMs) of a higher metrological order. Due to a lack of biological CRMs and RMPs (spanning from small molecules to protein to nucleic acids), IVD manufacturers are often unable to comply with regulation.
The COMET project will enable the IVD industry to meet the requirements of the IVDR EU/2017/746 regarding metrological traceability and performance verification of IVD tests. This will be achieved by establishing the necessary metrological infrastructure to provide cost-effective calibration services to IVD manufacturers to properly establish calibrated IVD tests and better monitor their performance. New certified reference materials and quality control materials will be produced for IVD tests which are in need for standardisation and post-market surveillance. National Measurement Institutes (NMIs) currently assure the traceability of their measurement results for a small number of highest priority clinical measurands by conduct comparison studies to demonstrate their equivalence and hence their capabilities for providing traceable measurement results for supporting globally comparable patient measurement results. Thes methods are often labour intensive and time consuming, with low sample throughput. Approaches for the automation of calibration procedures will be presented.
By developing more efficient ways to conduct commutability studies, the project will identify common causes of materials non-commutability commutability and the most appropriate manufacturing processes to consistently produce commutable calibrators and quality control materials. In the multiparameter commutability study, commutability of various candidate CRMs and EQA materials will be evaluated for a panel of measurands including Testosterone, calicum, glucose, total cholesterol, TG, HDLc, total protein, albumin, ALT and CK. EQALM members have been offered including their EQA materials in the study, making it possible to compare commutability of a large number of materials consisting of various matrices and prepared according to different materials.
The COMET project will enable the IVD industry to meet the requirements of the IVDR EU/2017/746 regarding metrological traceability and performance verification of IVD tests. This will be achieved by establishing the necessary metrological infrastructure to provide cost-effective calibration services to IVD manufacturers to properly establish calibrated IVD tests and better monitor their performance. New certified reference materials and quality control materials will be produced for IVD tests which are in need for standardisation and post-market surveillance. National Measurement Institutes (NMIs) currently assure the traceability of their measurement results for a small number of highest priority clinical measurands by conduct comparison studies to demonstrate their equivalence and hence their capabilities for providing traceable measurement results for supporting globally comparable patient measurement results. Thes methods are often labour intensive and time consuming, with low sample throughput. Approaches for the automation of calibration procedures will be presented.
By developing more efficient ways to conduct commutability studies, the project will identify common causes of materials non-commutability commutability and the most appropriate manufacturing processes to consistently produce commutable calibrators and quality control materials. In the multiparameter commutability study, commutability of various candidate CRMs and EQA materials will be evaluated for a panel of measurands including Testosterone, calicum, glucose, total cholesterol, TG, HDLc, total protein, albumin, ALT and CK. EQALM members have been offered including their EQA materials in the study, making it possible to compare commutability of a large number of materials consisting of various matrices and prepared according to different materials.
