SARS-CoV-2 variant of concern diagnostic assurance
Updated 14 April 2022
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The UK Health Security Agency (UKHSA) NHS Test and Trace programme carefully monitors test performance to provide assurance that nucleic acid and antigen tests that are in use by public providers are able to detect new SARS-CoV-2 variants (variants of concern (VOCs) and emerging variants (V)).
Find out more about COVID-19 (SARS-CoV-2) variants
Assurance processes, guidance and standards have been developed by members of the Variants of Concern Assurance Group. Members of the group include expert scientists and clinicians from all 4 UK administrations and representatives from the Medicines and Healthcare products Regulatory Agency (MHRA).
The VOC Assurance Group and MHRA monitor the performance of assays through:
- in silico monitoring (based on computer modelling)
- laboratory test performance quality monitoring
- in vitro testing (where indicated by the in silico and quality monitoring processes)
MHRA regularly engages with suppliers and manufacturers of test products in the UK to review their post-market assurance processes for the most recently published VOCs and Vs in circulation in the UK.
When a test product is impacted by a VOC or V, MHRA works with manufacturers to take mitigative actions and inform testing service providers.
All testing service providers (both public and private) can independently raise performance concerns using the dedicated coronavirus Yellow Card reporting system.
Urgent enquiries related to VOCs should be reported to covid19.variants@mhra.gov.uk
Private providers of SARS-CoV-2 antigen and nucleic acid tests should contact the MHRA at device.registrations@mhra.gov.uk to confirm that their tests products are registered and monitored.