Metrology to ensure rapid and accurate diagnostic response to current and emerging infectious diseases

The 2019 COVID-19 pandemic led to the premature death of millions of people and instigated “lock downs” for more than 3.9 billion around the world. Bioanalytical in vitro diagnostic (IVD) tests represent the first, and often only, available instrument for combating and preventing the spread of infectious diseases. Whilst the EU’s In Vitro Diagnostics Regulation (IVDR) requires “the metrological traceability of assigned values” for tests, this does not exist for bioanalytical IVDs. The lack of reference measurement systems to determine accuracy, limit of detection, measurement uncertainty, or the ability to or assign values to reference materials means that IVDs, often with different analytical performance, are deployed without the metrology to predict how they will work.

Building on previous EURAMET projects, including INFECT-MET, Bio-SITrace, AntiMicroResist, and SEPTIMET, this project will use model systems such as influenza, Mpox and tuberculosis, to develop a reference measurement infrastructure. A full calibration hierarchy will be established to provide the metrological traceability required by the IVDR and allow EU reference laboratories to improve point of care tests. Physical standards, materials and methods, with SI traceability and known measurement uncertainty, will also be established to support External Quality Assessment.

The work will provide IVD manufacturers, diagnostic developers and clinical laboratories with the tools to diagnose and fight existing or emerging infectious threats. It will also allow governments, and those responsible for monitoring, to prevent or limit outbreaks by ensuring they are armed with the most accurate epidemiological information on which to guide their decisions.