FOI release

Freedom of Information request on RT-PCR test cycle threshold (FOI 21/904)

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-rt-pcr-test-cycle-threshold-foi-21904

6th September 2021

FOI 21/904

Dear

Thank you for your Freedom of Information request of 7th August 2021 requesting

  1. all records in the possession, custody or control of the MHRA describing the isolation of a SARS-CoV-2 virus, directly from a sample taken from a Covid-19 diseased patient, where the patient sample was not first combined with any other source of genetic material (i.e. monkey kidney cells aka vero cells; lung cells from a lung cancer patient).
  2. inform me what your recommended RT-PCR Test Cycle Threshold is? Has this changed recently and, if so, when and why did it change? MHRA holds no information on the isolation of the Covid-19 virus. We suggest 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, including information on the isolation of the Covid-19 virus.

Please note that information on the isolation of the Covid-19 virus is also available in the public domain through scientific papers.

MHRA has not made cycle threshold recommendation for RT-PCR. Manufacturers of tests using RT-PCR technology will provide instructions for use which will include any procedures and settings that are required for use of their assay.

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. Their reports can be found by following the Link. You may also find this publication on Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR of interest.

You may also find of interest the publication by the Welsh Government Technical Advisory Cell, which provides scientific and technical advice to support Welsh Government decision making: Technical Advisory Cell: Principles for using RT-PCR test to detect SARS-CoV-2, published 15th July.

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: 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

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