INSTAND participates in the EU-funded joint research project for the manufacturing of commutable calibrators and quality control materials since 9/24
INSTAND participates in the EU-funded joint research project for the manufacturing of commutable calibrators and quality control materials since September 2024
For the EU-funded joint research project under the auspices of the European Association of National Metrology Institutes (EURAMET), European National Metrology Institutes, Designated Institutes and partners from medicine, science and industry have joined forces for the project “Manufacturing of commutable calibrators and quality control materials for standardisation and post-market surveillance of IVD tests” (short name COMET). The 3-year project started in September 2024 and aims to establish and provide the necessary metrological infrastructure, knowledge, and services for in vitro diagnostic (IVD) manufacturers to meet the European requirements of the In Vitro Diagnostic Medical Devices Regulation (IVDR) EU/2017/746.
According to the IVDR EU/2017/746, the metrological traceability of values assigned to calibrators and control materials shall be assured through certified reference materials (CRMs) of a higher metrological order and suitable reference measurement procedures (RMPs) to ensure a consistently high standard of IVD tests in Europe. Nowadays, manufacturers of commercial IVD tests are often unable to comply with these regulations because appropriate CRMs and RMPs are not yet available. The COMET project aims to reduce this gap by focusing on the metrological traceability and performance verification in order to support the IVD industry to meet the future legal requirements. This will be achieved through a functional metrological infrastructure which can offer cost-effective calibration services to IVD manufacturers and through the production of new CRMs and quality control materials which are needed for standardisation, harmonisation, and post-market surveillance of IVD tests through internal and external quality assessment (EQA). Furthermore, the project focuses on the complex subject of commutability, on general causes of non-commutability and on developing more efficient commutability studies with the overall objective to manufacture and provide commutable control materials.
In more detail, the COMET project seeks to develop SI-traceable, primary reference materials, fit for purpose calibrators and quality control materials with a focus on specific measurands including among others cyclosporine, parathyroid hormone (PTH), human cytomegalovirus (HCMV), bilirubin, estradiol, and panels of clinically relevant biomarkers and therapeutic drugs. These calibrators and control materials shall then be applicable for IVD manufacturers as well as EQA providers for evaluating and verifying the metrological traceability of clinical tests. Another project objective is to simplify the commutability assessment by developing more cost-effective and efficient commutability studies through abbreviated or multiparameter studies, the use of commutability panels and high-throughput RMPs as well as highly automated data analyses. For the high-throughput RMPs, the main project focus is on the measurands estradiol, PTH, and a panel of therapeutic drugs. For the commutability studies, a panel of clinically relevant biomarkers, bilirubin, PTH, HCMV, a panel of therapeutic drugs, and point-of-care tests for glucose will be investigated. Furthermore, at least one accuracy-based EQA scheme circulating commutable EQA material with assigned reference method target values will be conducted. Also, a European database shall be established where EQA data and information on commutable control materials are aggregated and shared with metrology institutes and industry partners. Finally, the COMET project seeks to create a lasting impact by providing the generated knowledge and measurement infrastructure to various stakeholders as IVD manufacturers, material producers, EQA providers, standards developing organisations, and medical associations.
Overall, the improvements and achievements of the COMET project will facilitate IVD manufacturers to comply with the requirements of the IVDR EU/2017/746 and even further international standards. Thereby, it will contribute to high quality standards of IVD tests and patient safety in general.
For the EU-funded joint research project under the auspices of the European Association of National Metrology Institutes (EURAMET), European National Metrology Institutes, Designated Institutes and partners from medicine, science and industry have joined forces for the project “Manufacturing of commutable calibrators and quality control materials for standardisation and post-market surveillance of IVD tests” (short name COMET). The 3-year project started in September 2024 and aims to establish and provide the necessary metrological infrastructure, knowledge, and services for in vitro diagnostic (IVD) manufacturers to meet the European requirements of the In Vitro Diagnostic Medical Devices Regulation (IVDR) EU/2017/746.
According to the IVDR EU/2017/746, the metrological traceability of values assigned to calibrators and control materials shall be assured through certified reference materials (CRMs) of a higher metrological order and suitable reference measurement procedures (RMPs) to ensure a consistently high standard of IVD tests in Europe. Nowadays, manufacturers of commercial IVD tests are often unable to comply with these regulations because appropriate CRMs and RMPs are not yet available. The COMET project aims to reduce this gap by focusing on the metrological traceability and performance verification in order to support the IVD industry to meet the future legal requirements. This will be achieved through a functional metrological infrastructure which can offer cost-effective calibration services to IVD manufacturers and through the production of new CRMs and quality control materials which are needed for standardisation, harmonisation, and post-market surveillance of IVD tests through internal and external quality assessment (EQA). Furthermore, the project focuses on the complex subject of commutability, on general causes of non-commutability and on developing more efficient commutability studies with the overall objective to manufacture and provide commutable control materials.
In more detail, the COMET project seeks to develop SI-traceable, primary reference materials, fit for purpose calibrators and quality control materials with a focus on specific measurands including among others cyclosporine, parathyroid hormone (PTH), human cytomegalovirus (HCMV), bilirubin, estradiol, and panels of clinically relevant biomarkers and therapeutic drugs. These calibrators and control materials shall then be applicable for IVD manufacturers as well as EQA providers for evaluating and verifying the metrological traceability of clinical tests. Another project objective is to simplify the commutability assessment by developing more cost-effective and efficient commutability studies through abbreviated or multiparameter studies, the use of commutability panels and high-throughput RMPs as well as highly automated data analyses. For the high-throughput RMPs, the main project focus is on the measurands estradiol, PTH, and a panel of therapeutic drugs. For the commutability studies, a panel of clinically relevant biomarkers, bilirubin, PTH, HCMV, a panel of therapeutic drugs, and point-of-care tests for glucose will be investigated. Furthermore, at least one accuracy-based EQA scheme circulating commutable EQA material with assigned reference method target values will be conducted. Also, a European database shall be established where EQA data and information on commutable control materials are aggregated and shared with metrology institutes and industry partners. Finally, the COMET project seeks to create a lasting impact by providing the generated knowledge and measurement infrastructure to various stakeholders as IVD manufacturers, material producers, EQA providers, standards developing organisations, and medical associations.
Overall, the improvements and achievements of the COMET project will facilitate IVD manufacturers to comply with the requirements of the IVDR EU/2017/746 and even further international standards. Thereby, it will contribute to high quality standards of IVD tests and patient safety in general.
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