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:
Last updated 14 February 2022 + show all updates
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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.