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

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Published 3 June 2020
Last updated 19 April 2021 +show all updates

  1. Updated list of validated LFD tests (‘Outcome of the evaluation of rapid diagnostic assays for specific SARS-CoV-2 antigens (lateral flow devices)’).

  2. Updated the attachment ‘National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) 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 new validated technology, ‘DNANudge’.

  4. 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.

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

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

  7. 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’.


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