How tests and testing kits for coronavirus (COVID-19) work
The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.
Documents
Details
Information for members of the public, patients, professionals and industry about COVID-19 tests and testing kits, including how they work, the different types of tests and the specifications manufacturers need to follow.
Further information on how medical devices are regulated:
Updates to this page
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The guidance on performing variant analysis for manufacturers of SARS-CoV-2 screening and diagnostic assays has been updated. Updated guidance documents are included for molecular and antigen tests as well as proformas to be completed every 60 days.
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The guidance 'For industry and manufacturers: COVID-19 tests and testing kits' was updated to include the correct email address for further information about CTDA ctda@mhra.gov.uk
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The guidance 'For industry and manufacturers: COVID-19 tests and testing kits' was updated to reflect that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.
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Paragraph added to this page which explains that the government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023.
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Edited according to UK government style guide
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Added Guidance for COVID-19 test device manufacturers intending to register their device with MHRA.
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Attachment added - Guidance for manufacturers: diagnostic assurance with SARS-CoV-2 variants in circulation
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Updated the TPPs for laboratory-based SARS-CoV-2 Viral Detection tests
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Added note - regarding new criteria for manufacturers introduced by DHSC
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Added a new Target Product Profile: In Vitro Diagnostic (IVD) self-tests for the detection of SARS-CoV-2 in people without symptoms
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A section on testing for international travel has been added to the document 'For patients, the public and professional users: a guide to COVID-19 tests and testing kits'.
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Added new section - Common terms related to COVID-19 testing
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Added new text under 'Self testing' about 'Concerns about the use of ethylene oxide in sterilising test swabs'
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Added new guidance page of testing kit providers
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Added information to the 'For industry and manufacturers: COVID-19 tests and testing kits' document. This now provides a link to DHSC information on the national standardised test performance process for manufacturers of SARS-CoV-2 virus antibody tests.
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Added a new document: Target Product Profile - Rapid Breath Tests for the direct and indirect detection of SARS-CoV-2
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The document for industry and manufacturers has been updated to include the new UKCA, CE and CE UKNI markings.
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Updated section on lateral flow testing and new section on reporting issues with testing kits, in the 'For patients, the public and professional users' document.
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Published a link to the National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests, from the Department of Health and Social Care (DHSC). Withdrew the 'Process for developing and evaluating novel molecular assays for COVID-19', as this has largely been replaced by the DHSC document.
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Updated guidance on submitting proposals for antibody tests in the attachment 'For industry and manufacturers: COVID-19 tests and testing kits'.
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Added information about lateral flow tests
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A Target Product Profile for Laboratory-Based SARS-CoV-2 Viral Detection Tests has been added.
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The guidance on testing kits has been re-written for both patients and the public and for manufacturers to make it clearer to understand.
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Re-written 'For patients, the public and professional users: a guide to COVID-19 tests and testing kits' to make it clearer how the different types of tests work, and who can use them.
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Added new Target Product Profile document for Point of Care SARS-CoV-2 detection tests
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Published a HTML version of the Target Product Profile: enzyme Immunoassay (EIA) Antibody tests document (which was published as a PDF on 5 June)
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Added Target Product Profiles for Enzyme Immunoassay (EIA) Antibody tests to help determine if people have antibodies to SARS-CoV-2
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In the 'For industry and manufacturers' section: added new content on performance evaluation process for test kits, re-worded the description of the TTP and re-worded the list of information to send for a device exemption application.
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Updated 'For patients, the public and professional users' and 'For industry and manufacturers' with new information on temporarily stopping the sale of COVID-19 antibody tests for members of the public until the regulatory and safety concerns are resolved.
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Added new HTML document on the process for developing and evaluating novel molecular assays for COVID-19
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First published.