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

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Published 3 June 2020
Last updated 4 May 2021 +show all updates

  1. Updated ‘National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests’ to add detail on performance results in the ‘Validated technology’ section.

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

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

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

  6. 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.

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



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