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

In vitro diagnostic tests are commonly used in medicine to measure biomarker concentrations, which will influence medical diagnosis and treatment options. The in vitro diagnostic regulation (IVDR) EU/2017/746 provides guidance and regulations around in vitro diagnostic tests to ensure a consistently high standard of medical tests is kept across Europe. As part of this regulation, manufacturers are required to assess the metrological traceability of values assigned to calibrators and/or control materials. This would usually be achieved through suitable reference measurement procedures (RMPs) or by using certified reference materials (CRMs), however manufacturers often struggle to provide this evidence.

The project seeks to address this metrological need by developing SI-traceable, primary reference materials for cyclosporine, parathyroid hormone and human cytomegalovirus, which are commonly used in in vitro diagnostic tests. Additionally, commutability studies will be made more cost-effective and efficient through the use of high-throughput RMPs, multiplexing and automatic data analysis. This will include high-throughput RMPs for estradiol, PTH, and a panel of immunosuppressive drugs. This approach can be extended to include more targets.  Finally, the project will generate a European database for External Quality Assessment (EQA) data aggregation, where materials of proved commutability can be added to be shared with other industry contacts and metrology institutes. These improvements of the metrological network will enable manufacturers to comply with IVDR EU/2017/746 and relevant standards such as ISO 15189 and ISO17025 and support the United Nation’s sustainable development goal for good health and well-being.