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.
Last updated 15 October 2020 + show all updates
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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.