Freedom of Information request on accuracy of lateral flow tests (FOI 21/727)
Published 29 December 2021
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-26-july-2021/freedom-of-information-request-on-accuracy-of-lateral-flow-tests-foi-21727
27th July 2021
FOI 21/727
Dear
Thank you for your information request dated 26 June 2021 asking for with data outlining the accuracy of lateral flow tests.
If you are referring to Lateral Flow Tests deployed as part of the national testing programme the Legal Manufacturer is the Department of Health and Social Care (DHSC). Unfortunately, the information we may hold is exempt from disclosure under Section 44 of the Freedom of Information Act 2000 (FOIA).
Section 44 – Prohibitions on disclosure: the release of information is exempt as its disclosure is prohibited by other legislation. In this case, section 237 of the Enterprise Act 2002 prohibits a public authority from releasing information which came to it in connection with the exercise of its functions, and which relates to the affairs of an individual or business.
The MHRA is satisfied that the information you have requested:
- constitutes information which came to us in connection with the exercise of the Agency’s functions. The MHRA has a duty of consumer protection under the Consumer Protection Act 1987 which is listed as a specified function under Schedule 14 of the Enterprise Act 2002, and receives information while exercising consumer protection functions in its role as the regulator of medicines and healthcare products.
- relates to the affairs of Department of Health and Social Care (DHSC) a business which continues to exist.
You may find helpful the lateral flow device performance data published by DHSC which can be found at Lateral flow device performance data - GOV.UK (www.gov.uk)
You may also find of interest the performance evaluation data published on the Government website: https://www.gov.uk/government/news/oxford-university-and-phe-confirm-high-sensitivity-of-lateral-flow-tests
This contains a link to an evaluation report.
Manufacturers will have data to support the performance claims made for the medical devices they place on the market. You may wish to contact them directly for this information.
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:
If you have a query about the information provided, please reply to this email.
Yours sincerely,
MHRA Customer Service Centre