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.

Documents

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

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

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

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Target Product Profile: Laboratory-Based SARS-CoV-2 Viral Detection tests

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National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests

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:

Published 13 May 2020
Last updated 20 January 2021 + show all updates
  1. 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 Withdrew the 'Process for developing and evaluating novel molecular assays for COVID-19', as this has largely been replaced by the DHSC document.

  2. Updated guidance on submitting proposals for antibody tests in the attachment 'For industry and manufacturers: COVID-19 tests and testing kits'.

  3. Added information about lateral flow tests

  4. A Target Product Profile for Laboratory-Based SARS-CoV-2 Viral Detection Tests has been added.

  5. The guidance on testing kits has been re-written for both patients and the public and for manufacturers to make it clearer to understand.

  6. 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.

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

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

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

  10. 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.

  11. 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.

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

  13. First published.