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Work from earlier EMPIR projects is used to support recovery from pandemic

The problem

Accurate and reliable detection of nucleic acids (DNA, RNA) is essential to maximise the potential of molecular diagnostic methods to assist in infectious disease management. Molecular methods, like Polymerase Chain Reaction (PCR) and sequencing, are essential in enabling the response to the current worldwide COVID-19 pandemic.

However, these measurements are difficult to make accurately. Ensuring reproducible testing is very challenging as methods are complex and the infectious agents can be present at very low levels in the body. This is not helped by the fact that reference measurement procedures are not well established in support of such testing, and established reference materials are only available for a handful of pathogens. This leads to inconsistent results across different laboratories mainly due to under-diagnosis, with positive COVID-19 patients and carriers going undetected with possible adverse consequences for patients and the wider community during an outbreak.

The EMPIR and EMRP research

Over the last decade, EURAMET has funded successive EMRP and EMPIR projects that have supported the measurement needs identified by the clinical community for the accurate and reproducible detection of infectious diseases. These include:

• Metrology for monitoring infectious diseases, antimicrobial resistance, and harmful micro-organisms (INFECT-MET, HLT08, 2012-2015)
• Novel materials and methods for the detection, traceable monitoring and evaluation of antimicrobial resistance (AntiMicroResist, 15HLT07, 2016-2019)
• New underpinning standards for improved bio-analytical measurement in Biotechnology & In vitro Diagnostics (Bio-stand, 16SIP01, 2017-2020)

These projects, which were coordinated by the National Measurement Laboratory (NML) at LGC, the UK’s designated measurement institute for biological and chemical metrology, have helped develop nucleic acid measurement capabilities across Europe. They have informed best practice for infectious disease diagnostics in the clinic, supported accreditation requirements and developed cutting edge methodology to improve international standardisation.

How the research is helping

Through this work, the European measurement community is well-positioned to foster the quick response to the COVID-19 pandemic and to support the standardisation of viral detection. This includes:

• Applying newly developed reference measurement procedures to improve standardisation for the new SARS-CoV-2 genome detection scheme run by external quality assurance provider INSTAND eV
• Participation in a fast-tracked inter-laboratory study for SARS-CoV-2 genome measurement through the International Consultative Committee for Amount of Substance: Metrology in Chemistry and Biology (CCQM) Nucleic Acid Analysis Working Group (NAWG)
• Supporting national testing laboratories through the provision of standards.

This work will support countries to ensure globally standardised testing by assisting diagnostic manufacturers with test development and providing quality assurance of routine COVID-19 testing, helping to tackle the spread of coronavirus and ensure preparedness for future outbreaks.

The European measurement community is continuing to develop metrology for diagnostic testing for infectious diseases through the EMPIR project Metrology to enable rapid and accurate clinical measurements in acute management of sepsis (SEPTIMET, 18HLT03).

EMPIR projects are co-funded by the European Union's Horizon 2020 research and innovation programme and the EMPIR Participating States.

EMRP joint research projects are part of EURAMET’s European Metrology Research Programme. The EMRP is jointly funded by the EMRP participating countries within EURAMET and the European Union.

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