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 20 January 2021 — 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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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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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

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

HTML

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

PDF, 300KB, 19 pages

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

https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/coronavirus-covid-19-serology-and-viral-detection-testing-uk-procurement-overview

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:

• In-house manufacture of medical devices in Great Britain
• In vitro diagnostic medical devices: guidance on legislation

Published 13 May 2020
Last updated 20 January 2021 + show all updates

1. 20 January 2021

   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. 23 December 2020

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

3. 20 November 2020

   Added information about lateral flow tests

4. 15 October 2020

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

5. 22 September 2020

   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. 10 July 2020

   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. 26 June 2020

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

8. 12 June 2020

   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. 5 June 2020

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

10. 29 May 2020

    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. 28 May 2020

    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. 19 May 2020

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

13. 13 May 2020

    First published.