Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether his Department has undertaken sensitivity testing of the Innova SARS-CoV-2 Antigen Rapid Qualitative Test when the test is used according to the instructions set out in the guide published by his Department and NHS Test and Trace entitled Your step-by-step guide for Covid-19 self testing.

The Department has undertaken sensitivity testing of the Innova SARS-CoV-2 Antigen Rapid Qualitative Test when the test is used according to the instructions set out in the guide published by the Department and NHS Test and Trace, entitled ‘Your step-by-step guide for COVID-19 self-testing’. The results are available at the following link:

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/999866/asymptomatic-testing-for-SARS-CoV-2-using-antigen-detecting-lateral-flow-devices-evidence-from-performance-data-Oct-2020-to-May-2021.pdf

Devices are also tested for robustness, usability and evidence of cross-reactivity with seasonal coronaviruses.

Post-marketing surveillance is performed on approved devices at regular intervals to ensure they remain fit for purpose against new variants.