GovWire

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

Department Of Health

October 4
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 4 October 2021 +show all updates
  1. Updated the appeals process within 'National standardised test performance process for manufacturers of SARS-CoV-2 virus antibody tests'.

  2. Updated 'National standardised test performance process for manufacturers of SARS-CoV-2 virus antibody tests' to include all new products in the pipeline as of 13 September 2021.

  3. Added new test: SARS CoV-2 + Influenza A/B (Roche Cobas Liat) to the 'Validated technology' table in 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests'.

  4. 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.

  5. Removed 'Coronavirus test device authorisations operating process for SARS-CoV-2 tests' as out of date.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'.

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