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Coronavirus: Screening

Question for Department of Health and Social Care

UIN 33282, tabled on 14 July 2021

To ask the Secretary of State for Health and Social Care, what the evidential basis was for the Medicines and Healthcare products Regulatory Agency to conclude that the concerns raised by the US Food and Drug Administration on the NHS rebranded Innova lateral flow tests did not apply to the UK market.

Answered on

19 August 2021

NHS Test and Trace have taken on the role of legal manufacturer of the self-tests which have been given a Medicines and Healthcare products Regulatory Agency (MHRA) Exceptional Use Authorisation (EUA) for the purpose of detection of COVID-19 in asymptomatic individuals as part of the national testing programme. As a legal manufacturer, NHS Test and Trace are required to have a Quality Management System (QMS) in place. The QMS is separate to that of 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.

On becoming aware of the United States Food and Drug Administration (FDA) safety notice issued on 10 June, in line with our normal processes the MHRA immediately asked NHS Test and Trace to investigate whether the UK could be affected by any of the concerns raised by FDA. The MHRA considered the information supplied by NHS Test and Trace and were satisfied of the limited applicability of the FDA’s actions in the USA to the products supplied in the UK by NHS Test and Trace and their proposed actions to mitigate risks from these issues.

The Department has recently published full information and data on the performance of lateral flow tests in the UK which demonstrates that the tests have a high level of accuracy and sensitivity, and can be found at the following link:

The MHRA has extended the EUA to Test and Trace until 28 August 2021. The duration of an EUA can differ for a number of reasons; in this instance a shorter extension was considered appropriate. This does not preclude the EUA from potential further extensions if requested. The relatively short extension allows us to keep the situation under review.