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Guidance: Assessment and procurement of coronavirus (COVID-19) tests

Department Of Health

September 8
08:36 2021

Details

This page contains guidance to help developers of COVID-19 tests understand how their tests are assessed for procurement and use in the UK.

Published 3 June 2020
Last updated 8 September 2021 +show all updates
  1. Updated 'COVID-19 test approval step 2: process for desktop review' to explain the use of the full dynamic range data for the regulation assessment and add an email address to request TVG data.

  2. Removed 'Coronavirus test device authorisations operating process for SARS-CoV-2 tests' as out of date. Up-to-date information is in the document 'COVID-19 test approval step 2: process for desktop review'.

  3. Added updated guidance 'COVID-19 test approval step 2: process for desktop review' to replace 'Coronavirus test device authorisations: desktop review (stage 2) operating process for SARS-CoV-2 tests'. The guidance has been updated to include information on the requirements for the comparator test, the performance thresholds for different technology types and an explanation of how the performance of a test will be assessed against the thresholds.

  4. Updated to add 2 further validated lateral flow devices to the table in 'Outcome of the evaluation of rapid diagnostic assays for specific SARS-CoV-2 antigens (lateral flow devices)'.

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