FOI release

Freedom of Information request on the approval of the PCR testing kits for COVID-19 (FOI 21/1096)

Published 27 April 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-11-october-2021/freedom-of-information-request-on-the-approval-of-the-pcr-testing-kits-for-covid-19-foi-211096

11th October 2021

FOI 21/1096

Dear

Thank you for your Freedom of Information request of 1st October 2021 requesting

  1. Scientific studies, articles or other data, whether carried out by your organisation or by others, which conclusively proves that a positive PCR test following a positive lateral flow test (neither of which is capable of determining infection status) is sufficient to “confirm” diagnosis of infection with Covid-19.

  2. In absence of material evidence for Q1, please provide the basis by which your organisation relies on PCR being capable of confirmation of Covid-19 infection following a positive lateral flow test.

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. MHRA has not made recommendation for clinical use of PCR and not undertaken scientific studies on PCR technology. Manufacturers of tests using PCR technology will provide instructions for use which will include statements of the intended use for their device.

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

We suggest that you should 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.

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

Yours sincerely,

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

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