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

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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 28 May 2020 + show all updates
  1. 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.

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

  3. First published.