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

Posted on:

Published 3 June 2020
Last updated 17 March 2021 +show all updates

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

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

  3. 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’.

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

  5. 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’.

  6. 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.

  7. 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.



Source link