Manufacturing of commutable calibrators and quality control materials for standardisation and post-market surveillance of IVD tests.

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Research unit

SERI

Project number

25.00045

Project title

Manufacturing of commutable calibrators and quality control materials for standardisation and post-market surveillance of IVD tests.

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Abstract	-	-	-

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Abstract (English)	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. This project will enable the IVD industry 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 in need for standardisation and post-market surveillance. By developing more efficient ways to conduct commutability studies, the project will identify common causes of poor commutability and improving the manufacturing process.

Category

Text

Abstract
(English)

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. This project will enable the IVD industry 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 in need for standardisation and post-market surveillance. By developing more efficient ways to conduct commutability studies, the project will identify common causes of poor commutability and improving the manufacturing process.