FOI release

Freedom of Information request on the if Innova Lateral Flow Tests are still being used and issued past the original agreed EUA date of the 28th August 2021 (FOI 21/1282)

Published 31 May 2022

FOI 21/1282

24th December 2021

Dear,

Thank you for your FOI request of 23rd November for information on if Innova Lateral Flow Tests are still being used and issued past the original agreed EUA date of the 28th August 2021; what other makes of LFT’s are in circulation within England and Wales and how many and lastly, the accuracy data for these.

An extension to the exceptional use authorisation of the Department of Health and Social Care (DHSC) COVID 19 Self-test to detect infection in asymptomatic individuals (Repurposed Innova/Biotime Test Kit) to detect positive cases amongst asymptomatic people, one-off testing prior to an activity to reduce risks, outbreak testing and asymptomatic testing was granted. A list of devices which have been given exceptional use authorisations is published on our website: List of medical devices given exceptional use authorisations - GOV.UK (www.gov.uk).

DHSC have published lateral flow performance data which can be found at Lateral flow device performance data - GOV.UK (www.gov.uk)

Manufacturers of CE, CE UKNI and UKCA marked devices sold in the UK for SARS-CoV-2 antigen IVD kit can be found on the Public Access Database for Medical Device Registration. In vitro diagnostic medical devices for performance evaluation are not published on this database. Listing may become subject to new CTDA criteria. The UK Health Security Agency (UKHSA) have introduced new criteria for manufacturers seeking to place their tests on the market in the UK. This is known as COVID Testing Devices Authorisation (CTDA). All tests for COVID-19 must comply with the Medical Devices Regulations 2002 (as amended) and fulfil the requirements outlined here.

CE/CE UKNI/UKCA marked Tests specifically used for self-testing will need to have been deemed acceptable by an Approved or Notified Body. This is indicated by a 4-digit identifier number next to the CE mark symbol on the packaging.  MHRA does not undertake performance testing of CE marked devices or hold manufacturers sales figures and recommend that you ask the manufacturer of the test for this information. Further information on covid-19 tests and tests kits which may be helpful can be found at: For patients, the public and professional users: a guide to COVID-19 tests and testing kits - GOV.UK (www.gov.uk)

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for an internal review. It will be carried out by a senior member of the Agency who was not involved with the original decision. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review.

The Information Commissioner can be contacted online: https://ico.org.uk/make-a-complaint/official-information-concerns-report/official-information-concern/

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices.

Please remember to quote the reference number above in any future communications.

Yours sincerely,

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 020 3080 6000