FOI release

Freedom of Information request on confirmation of why the PCR test was granted authorization for use by your department when it is not fit for purpose (FOI 21/1171)

Published 26 May 2022

FOI 21/1171

3rd December 2021

Dear,

Thank you for your FOI enquiry dated 28th October in which you asked MHRA to “confirm why the PCR test was granted authorization for use by your department when it is not fit for purpose” and provide information about PCR tests:

1. Does the PCR test only detect viral matter
2. How does the PCR test distinguish between sars covid 2 and other coronavirus like say flu or the common cold
3. Can the PCR test be used to detect infectious viral diseases if so how
4. Was the PCR test tested with confirmation on a pure isolated sample of sars covid 2
5. Who in your department authorised the use of the PCR test
6. Was the MHRA advised to use the PCR tests by any other organisation or individual

Most compliant medical devices will display a valid CE, CE UKNI or UKCA mark. These marks are a declaration by the manufacturer that the test meets the required standards of safety and performance. These regulatory requirements aim to ensure that the products do not compromise the safety of patients and users and are designed and manufactured to achieve the performance specified by the manufacturer for the stated purpose.  CE, CE UKNI and UKCA marks are not issued by the MHRA. They are placed on the product by the manufacturer.

In exceptional circumstances if a device does not yet have a UKCA or CE mark a manufacturer can apply to MHRA for a derogation. Information on the requirement for devices to be considered for exceptional use authorisation (EUA) can be found at: For industry and manufacturers: COVID-19 tests and testing kits - GOV.UK (www.gov.uk). A list of devices which have been given exceptional use authorisations is also published on our website: List of medical devices given exceptional use authorisations - GOV.UK (www.gov.uk).  There are currently no UK granted exceptional use authorisations for a polymerase chain reaction (PCR) test.

To address your questions I am pleased to provide you the following information and references to the scientific literature if you wish to learn more on this topic. The PCR test works by using small fragments of DNA (primers) added into a reaction mix that complements the target region of the viral genome. Further details of the PCR process can be found from page 7 of the following publication in July 2020 by the Welsh Government Technical Advisory Cell, which presents key information about the RT-PCR for the detection of SARSCoV-2 virus.: Technical Advisory Cell: Principles for using RT-PCR test to detect SARS-CoV-2.

PCR tests use primers that target specific genetic material to the virus of interest. You may be interested to know that Public Health England (PHE) had undertaken rapid assessments of commercially provided diagnostic tests for SARS-CoV-2 nucleic acid detection. Their assessment used a panel of samples consisting of residual nucleic acids extracted from a number of specimens. You can access their reports for the different commercially available tests at:

https://www.gov.uk/government/publications/covid-19-phe-laboratory-assessments-of-molecular-tests.

Viruses can change over time and manufacturers of tests constantly monitor the performance of their tests as part of their post market surveillance to ensure they continue to be effective at detecting the virus of interest. The Department of Health and Social Care NHS Test and Trace programme carefully monitors test performance to provide assurance that nucleic acid and antigen tests that are in use by public providers are able to detect new SARS-CoV-2 variants (variants of concern (VOCs) and variants under investigation (VUIs)). More information can be found at SARS-CoV-2 variant of concern diagnostic assurance - GOV.UK (www.gov.uk)

According to the Welsh Government publication of July 2020 mentioned above, the use of RT-PCR as a tool to inform absence of infectivity comes with limitations as viral RNA can be detected for up to 50 days following infection. We suggest for the latest information that you consult the Scientific Advisory Group for Emergencies (SAGE) website (https://www.gov.uk/government/organisations/scientific-advisory-group-for-emergencies), which includes information supporting the governments’ decision making on the Covid-19 pandemic. MHRA has not been involved in the research characterisation of virus and holds no information on the isolation of the Covid-19 virus.

The use of CE/UKCA marked PCR tests by the NHS does not require MHRA approval and we are informed by the NHS guidance for the use of COVID 19 tests as provided to the general public. The latest guidance can be found at: https://www.nhs.uk/conditions/coronavirus-covid-19/testing/get-tested-for-coronavirus/

I hope you will find this helpful.

If you have a query about the information provided, please reply to this email

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: [email protected]

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

Yours sincerely

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU