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

Published 3 June 2020
Last updated 7 January 2021 +show all updates

  1. 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.

  2. 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.

  3. 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’.

  4. 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.

  5. 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) assessment’ to ‘First wave of lateral flow test and non-machine based LFT assessment’.

  6. In the attachment National technical validation process for manufacturers of SARS-CoV-2 (COVID-19), updated information about technologies in the pipeline, added new information about validations concluded or paused and added new information and reports on validated technology.

  7. In ‘National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests’, updated information about technologies in the pipeline.

  8. Small amendments made to first 2 paragraphs in ‘National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests’ for clarity.

  9. Updated to reflect the new process for validating new COVID-19 viral detection tests. Previously these were assessed by a group called the Viral Detection Test Advisory Group (VTAG) but this process has changed.

  10. This guidance now only applies to viral detection testing. The guidance has been updated to reflect that the New Tests Advisory Group is no longer accepting new serology or antibody tests.


  11. First published.


Source link