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

Department Of Health

April 6
09:38 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 6 April 2021 +show all updates
  1. Updated the 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests' document to add new validated technology, 'DNANudge'.

  2. Updated the attachment 'National standardised test performance process for manufacturers of SARS-CoV-2 virus antibody tests' to update the products in the pipeline table.

  3. Updated the National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests document to add information about antibody test manufacturers.

  4. Added new document: 'National standardised test performance process for manufacturers of SARS-CoV-2 virus antibody tests'.

  5. Updated and removed a table from the 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests' document to create the new document 'Products in the pipeline (TVG): validation concluded or paused'.

  6. Updated the 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests' document to update the 'Validation stage' table.

  7. Updated the 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests' document to add 2 new validated technologies, 'LumiraDx: POC rapid COVID-19 Ag test' and 'Primer Design Ltd: PROmate direct: qRT-PCR'.

  8. Updated 'National technical validation process

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