This page contains guidance to help developers of COVID-19 tests understand how their tests are assessed for procurement and use in the UK.
Updated the 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests' document to add new validated technology, 'DNANudge'.
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.
Updated the National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests document to add information about antibody test manufacturers.
Added new document: 'National standardised test performance process for manufacturers of SARS-CoV-2 virus antibody tests'.
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'.
Updated the 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests' document to update the 'Validation stage' table.
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'.
Updated 'National technical validation process
