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

Department Of Health

March 5
11:54 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 5 March 2021 +show all updates
  1. Updated the 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests' document to update the 'Validation stage' table.

  2. 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'.

  3. Updated 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests' to reflect the number of technologies currently in the TVG pipeline.

  4. Updated 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests' to clarify the procurement process and to reflect the number of technologies currently in the TVG pipeline.

  5. Updated the 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests' document to add a new validated technology, Abbott.

  6. Updated the 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests' document to delete a validated technology (Latus) and add a new validated technology (Nonacus).

  7. Updated the 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests' document to update the 'Products in the pipeline' table and add a new validated technology, Latus.

  8. Updated 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests': added guidance for antibody test manufacturers about registering interest; added that an alternative technical validation route will be required for any non-machine based LFT and home testing kits; and removed Tenders Electronic Daily as a source of further procurement opportunities.

  9. Added Oxford Nanopore: LamPORE: RNA RT-qPCR to validated technology table in 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests'.

  10. Updated 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests' to reflect the number of technologies currently in the TVG pipeline.

  11. Updated 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests' to add a new validated technology (QuantuMDx), edited links under 'Publication of results' and amended title of 'First wave of non-machine based lateral flow technology (LFT) ass

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