FOI release

Freedom of Information request on PCR test for detecting COVID-19 (FOI 20-573)

Published 24 March 2021

Thank you for your email of 22 December 2020 in which you asked us about the “accuracy of the PCR test for detecting Covid-19”.

I can confirm that the MHRA does not hold this information. Different PCR tests will have different performance claims. In response to similar recent questions about the accuracy of PCR tests we have offered the following information which may be of interest to the enquirer:

You may be interested to know that Public Health England (PHE) has undertaken rapid assessments of commercially provided diagnostic tests for SARS-CoV-2 nucleic acid detection. You can access their reports on this page. You may also find this publication on Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR of interest. You may also be aware that the Welsh Government Technical Advisory Cell, which provides scientific and technical advice to support Welsh Government decision making, has published a paper on the topic: Technical Advisory Cell: Principles for using RT-PCR test to detect SARS-CoV-2, published 15th July.

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.

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 Telephone 020 3080 6000