Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will publish (a) details of the MHRA's review into the Innova covid-19 lateral flow tests and (b) criteria applied to determine that those tests are satisfactory for use.

The Department and NHS Test and Trace have taken on the role of legal manufacturer for lateral flow self-tests, which have been given a Medicines and Healthcare products Regulatory Agency (MHRA) exceptional use authorisation for the purpose of detection of COVID-19 in asymptomatic individuals as part of the national testing programme. As legal manufacturer, the Department and NHS Test and Trace are required to have a Quality Management System (QMS) in place. The QMS is separate to that of the Innova Medical Group in the United States of America (USA) and ensures that tests being used in the United Kingdom (UK) are subject to appropriate controls.

After the US Food and Drug Association safety notice was issued on 10 June, MHRA asked the Department and NHS Test and Trace to investigate whether the UK could be affected by any of the concerns raised. MHRA were satisfied of the limited applicability of the FDA’s actions in the USA to the products supplied in the UK by the Department and NHS Test and Trace and their proposed actions to mitigate risks from these issues.

The Department published information and data on the performance of lateral flow tests in the UK which can be found at the following link:

https://www.gov.uk/government/publications/lateral-flow-device-performance-data