Guidance

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.

Published 13 May 2020
Last updated 26 June 2020 — see all updates
From:
Medicines and Healthcare products Regulatory Agency

Documents

For patients, the public and professional users: a guide to COVID-19 tests and testing kits

HTML

For industry and manufacturers: COVID-19 tests and testing kits

HTML

Target Product Profile: Point of Care SARS-CoV-2 detection tests

HTML

Target Product Profile: Point of Care SARS-CoV-2 detection tests

PDF, 337KB, 19 pages

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If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Target Product Profile: antibody tests to help determine if people have recent infection to SARS-CoV-2: Version 2

HTML

Target Product Profile: antibody tests to help determine if people have recent infection to SARS-CoV-2: Version 2

PDF, 138KB, 18 pages

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Process for developing and evaluating novel molecular assays for COVID-19

HTML

Target Product Profile: enzyme immunoassay (EIA) antibody tests to help determine if people have antibodies to SARS-CoV-2

PDF, 211KB, 12 pages

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Target Product Profile: enzyme Immunoassay (EIA) Antibody tests to help determine if people have antibodies to SARS-CoV-2

HTML

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.

Published 13 May 2020
Last updated 26 June 2020 + show all updates

  1. Added new Target Product Profile document for Point of Care SARS-CoV-2 detection tests

  2. Published a HTML version of the Target Product Profile: enzyme Immunoassay (EIA) Antibody tests document (which was published as a PDF on 5 June)

  3. Added Target Product Profiles for Enzyme Immunoassay (EIA) Antibody tests to help determine if people have antibodies to SARS-CoV-2

  4. 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.

  5. 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.

  6. Added new HTML document on the process for developing and evaluating novel molecular assays for COVID-19

  7. First published.

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