Freedom of Information request on the testing efficacy rates and all adverse reactions associated to lateral flow antigen testing since it's introduction (FOI 21/1159)
Published 26 May 2022
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FOI 21/1159
22nd November 2021
Dear,
Thank you for your information request, dated 25 October, where you asked ‘Please provide answers to the questions below which are being requested under the Freedom of Information Act 2000.
- What are the testing efficacy rates?
- Please provide statistics from a fully independent company proving rigorous testing, control groups and the outcomes.
- Please advise of all adverse reactions associated to lateral flow antigen testing since its introduction.
- Please provide a full list of test ingredients and state if any are toxic to the body?
- If for any reason I have an allergic reaction or there is any harm or damage caused to me as a result of taking the tests bi-weekly for the foreseeable future, who is held accountable?’
I am pleased to provide you with some of the information requested. Please find below a list of adverse reactions associated to lateral flow antigen testing thus far:
Adverse/Allergic reaction
Blood/Fluid Loss
Delay to diagnosis
Headache
Cuts/bruises
Palpitation
Rash
Infection
Adverse Psychological effect
Anxiety
Memory Loss/Impairment
Pain
Skin Inflammation/ Irritation
The list is accurate at the time it was taken from our database, and minor changes can occur if incident reporters give us more details later.
Please note that a report of an adverse incident does not mean the testing device caused the incident. Moreover, the information we hold on our database is not a full picture of all the device-related incidents that happened during this period, it is just a snapshot.
Therefore, our data should NOT be used to make a judgement on the safety of this type of testing devices (lateral flow antigen tests) or how likely it is to be involved in an adverse incident when using this type of device.
Unfortunately, the rest of the information you requested is exempt from release under 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 the manufacturers of the tests, businesses which continue to exist.
On that basis we are satisfied that section 44 of FOI Act applies and the information is exempt from release.
We recommend that you contact the legal manufacturer(s) of the test(s) directly with regards to these requests as they may be able to provide you with more details. Manufacturers will have data to support the performance claims made for the medical devices they place on the market, and will monitor the performance of the medical device they produce as part of their post market surveillance. You may be interested to know performance evaluation data has been published on the Government website: https://www.gov.uk/government/news/oxford-university-and-phe-confirm-high-sensitivity-of-lateral-flow-tests.
With regards to your last question, we are unfortunately unable to advise on potential liability issues and would recommend you to seek independent legal advice as this question falls outside the MHRA’s remit.
If you have a query about the information provided, please reply to this email.
If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review 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
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.
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 at:
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF