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The National Institute for Biological Standards and Control

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  • SoGAT forum

SoGAT diagnostic forum focuses on COVID-19

ast month, established teams embraced new ways of working, when NIBSC hosted the 29th meeting and the first virtual workshop of SoGAT, focusing on molecular diagnostics for SARS-CoV-2. SoGAT (Standardisation of Genome Amplification Techniques) was established in 1994 to improve measurement by what were then the new molecular tests for blood-borne viruses (such as hepatitis C and HIV), which were seen as essential to underpin the safety of blood and blood products.

The SoGAT community comprises diagnostic laboratories, regulators, manufacturers, and other stakeholders who recognise the importance of harmonising measurement in these molecular tests to assure patient safety.

SoGAT provides an expert forum to support the diagnostic community and guides the development of reference materials, particularly WHO International Standards that harmonise measurement by these assays around the world. Over the years the meeting has needed to address issues raised by emerging or re-emerging pathogens.


This year’s workshop focused on the challenges presented by the COVID-19 pandemic. It opened with presentations which highlighted the challenges faced by diagnostic laboratories needing to develop and deploy rapidly molecular tests for this new pathogen SARS-CoV-2. Regulatory laboratories described how COVID-19 tests have been evaluated and approved globally using emergency procedures to expedite the availability of diagnostic tests.

Teams running proficiency testing programmes for SARS-CoV-2 around the world presented an insight into the performance and problems arising from the development and use of these newly implemented tests over the past year. They highlighted the importance of establishing internationally recognised reference materials to aid the comparison of results across laboratories and improve the performance of assays being used by diagnostic laboratories.

On day two, the development of certified reference materials for SARS-CoV-2 and their qualification using droplet digital PCR was described. These materials provide a stepping stone in the development of sensitive and specific assays. The contribution played by Next Generation Sequencing to ensure that COVID-19 tests detect variants was also discussed.

The final session allowed NIBSC to provide an update and share information on the reference materials which we have produced and are working on. These include WHO International Standards for SARS-CoV-2 antigen tests as well as molecular assays. These materials are a gold standard against which regional, national and international laboratories and manufacturers calibrate their own working reference materials.

The virtual workshop concluded with a broad discussion on the lessons learned and how the group can best collaborate in the future to prepare for the next challenge whatever that might be.

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