Freedom of Information request on analysis prints for all coronavirus testing kits (FOI 21-897)
Published 25 February 2022
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-6-september-2021/freedom-of-information-request-on-analysis-prints-for-all-coronavirus-testing-kits-foi-21-897
7th September 2021
FOI 21/897
Dear
Thank you for your information request, dated August 9th, where you asked for
- Analysis prints for all coronavirus testing kits that are or have previously been regulated and/or licenced by MHRA (including conditional and emergency authorisation), in a similar way to how the analysis prints for coronavirus vaccinations are currently published.
We can provide you the following data breakdown of the reported adverse incidents received by MHRA between 23/04/2020 -06/08/2021, where coronavirus testing kits was stated(i.e involving , PCR tests (including sample collection kits), Antibody tests, Antigen lateral flow tests (LFD) Antigen point-of-care tests /laboratory instrumentation and is listed in the table below. A single report may contain more than one symptom).
| PCR tests (including sample collection kits) | Antibody tests | Antigen lateral flow tests (LFD) | Antigen point-of-care tests/laboratory instrumentation | |
|---|---|---|---|---|
| Adverse/allergic reactions including headache, pain, respiratory affect, burning sensation, rush, swelling, irritation/inflammation, muscle spasms/cramps, dizziness, chest pain, palpitation, asthma, fatigue | 68 | <5 | 54 | <5 |
| Blood/fluid loss including nosebleed | 27 | <5 | 17 | <5 |
| Cut/bruises | 7 | <5 | <5 | <5 |
| Delay to diagnosis, delay to treatment, inadequate/inappropriate treatment, absence of treatment | 21 | <5 | 7 | <5 |
| Foreign body retention, prolonged episode of care | 10 | <5 | <5 | <5 |
| Other clinical effects including vomiting, pain, respiratory affect, embolism, unexpected deterioration, fall, infection, inflammation, anxiety, memory loss/impairment, muscle pain, fracture of bone, shaking/tremors | 43 | 7 | 10 | <5 |
The data is not specific to a particular manufacturer. The number of reports is accurate at the time they were taken from our database, and minor changes in the numbers can occur if the reporter of the incident gives us more details later.
We cannot share information about specific manufacturers of medical device including COVID-19 tests because of the confidentiality clause of the legislation that we work under. This includes providing information on individual incidents we have received involving coronavirus testing kits. Please be assured that if there is a problem that affects patient safety, we will take action.
The inclusion of a report on our adverse incident database does not necessarily mean the events described were caused by that medical device but could be due to unrelated patient/user factors. 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 device or how likely an adverse incident may occur when using this type of device.
The reason for reporting can be just a suspicion that an incident or adverse effect was caused by a device or the way in which it was being used. Reports might be related to events which resulted in no injury, minor injury or a death or serious deterioration in health or the potential for these events to occur.
It is not compulsory for healthcare professionals and members of the public to report incidents directly to MHRA, but we strongly encourage this.
MHRA continues to monitor the safety and performance of all medical devices and encourages patients to report any adverse incidents. For COVID-19 testing devices, these can be reported via the Pandemic Yellow Card Portal at https://coronavirus-yellowcard.mhra.gov.uk/
The Freedom of Information Act only entitles you access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information
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. You should submit the request within 2 months of the date you receive this response and send it to: info@mhra.gov.uk.
Kind regards,
MHRA Customer Service Centre