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Developing reference materials and standards to fight against the spread of the coronavirus

EURAMET’s network for traceability in laboratory medicine (TraceLabMed) is striving to provide continuing contributions to the global COVID-19 response. One of their influential members, the UK’s National Institute for Biological Standards and Control (NIBSC), has fast-tracked the development of key reference materials and research reagents to support European efforts to tackle this pandemic.

About the NIBSC

As an expert centre of the UK Medicines and Healthcare products Regulatory Agency, the NIBSC plays a major role in assuring the quality of biological medicines and diagnostics worldwide. By building on the expertise gained through work on previous virus outbreaks like Zika, Ebola and the Middle East respiratory syndrome (MERS), the institute has rapidly responded to the current coronavirus pandemic. The NIBSC’s vital work continues to support scientists and clinicians with diagnostics, vaccine development and other research initiatives surrounding SARS-CoV-2, the new strain of coronavirus, and COVID-19, the disease caused by it.  

Recent work with reference materials & standards

The NIBSC is responsible for developing biological standards and reference materials to underpin the effective use of diagnostics, vaccines and biotechnology products. Recently, the institute has provided research reagents for SARS-CoV-2 RNA and anti-SARS-CoV-2 antibody, to support the development and evaluation of molecular and serological assays, respectively.

Two CE-marked materials have also been produced for diagnostic laboratories, that comply with European Economic Area standards and fulfil the requirements of the International Organisation for Standardisation (specifically, ISO 15189) - for reference materials that are used in medical laboratories. The two materials in question are a SARS-CoV-2 NAT reagent that acts as a run control to ensure the fidelity and reproducibility of molecular assays, and an External Quality Control reagent for anti-SARS-CoV-2 serological assays

The NIBSC’s work with the WHO

The NIBSC is the major producer and distributor of World Health Organization (WHO) international standards. On behalf of the WHO, the institute is currently developing international standards for SARS-CoV-2 RNA and anti-SARS-CoV-2 antibody - as well as a WHO reference panel for anti-SARS-CoV-2 antibodies. These calibrant materials are expected to be available in December 2020 once they have been evaluated in an international collaborative study.  

Additionally, the Centre for AIDS Reagents - based at the NIBSC - has also been providing invaluable contributions to the pandemic response. Initially set up to focus on research reagents for HIV/AIDS research, the centre is now offering an expanding collection of COVID-19-related biological materials for essential research purposes.

Altogether, these materials will improve diagnostic capabilities and support the development of effective vaccines and treatments for COVID-19. For more information about the NIBSC’s ongoing work, please visit their  website. 

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