Guidance

Assessment and procurement of coronavirus (COVID-19) tests

How the government assesses offers of COVID-19 tests from developers for procurement and use in the UK.

Published 3 June 2020
Last updated 1 December 2021 + show all updates
  1. Updated 'Validated technology' table in 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests' to add another molecular device.

  2. Updated 'Outcome of the evaluation of rapid diagnostic assays for specific SARS-CoV-2 antigens (lateral flow devices)' to add 6 more lateral flow devices that have passed 3a validation.

  3. Updated the appeals process within 'National standardised test performance process for manufacturers of SARS-CoV-2 virus antibody tests'.

  4. Updated 'National standardised test performance process for manufacturers of SARS-CoV-2 virus antibody tests' to include all new products in the pipeline as of 13 September 2021.

  5. Added new test: SARS CoV-2 + Influenza A/B (Roche Cobas Liat) to the 'Validated technology' table in 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests'.

  6. Updated 'COVID-19 test approval – step 2: process for desktop review' to explain the use of the full dynamic range data for the regulation assessment and add an email address to request TVG data.

  7. Removed 'Coronavirus test device authorisations operating process for SARS-CoV-2 tests' as out of date. Up-to-date information is in the document 'COVID-19 test approval – step 2: process for desktop review'.

  8. Added updated guidance 'COVID-19 test approval – step 2: process for desktop review' to replace 'Coronavirus test device authorisations: desktop review (stage 2) operating process for SARS-CoV-2 tests'. The guidance has been updated to include information on the requirements for the comparator test, the performance thresholds for different technology types and an explanation of how the performance of a test will be assessed against the thresholds.

  9. Updated to add 2 further validated lateral flow devices to the table in 'Outcome of the evaluation of rapid diagnostic assays for specific SARS-CoV-2 antigens (lateral flow devices)'.

  10. Temporarily removed 'Coronavirus test device authorisations: desktop review (stage 2) operating process for SARS-CoV-2 tests' while it is being updated.

  11. Updated the 'Validated technology' table in 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests' to add 3 new tests: BD Veritor System and VMD Health (UK) and Alveo Technologies Inc.: be.well™ COVID-19 test. Added 'Assure Tech Ecotest COVID-19 Antigen Rapid Test Device' to Outcome of the evaluation of rapid diagnostic assays for specific sars cov-2 antigens lateral flow devices.

  12. Updated the number of lateral flow devices PHE Porton Down and University of Oxford SARS-CoV-2 lateral flow antigen test validation cell has evaluated in the 'Outcome of the evaluation of rapid diagnostic assays for specific SARS-CoV-2 antigens (lateral flow devices)' attachment.

  13. Updated the number of lateral flow devices PHE Porton Down and University of Oxford SARS-CoV-2 lateral flow antigen test validation cell has evaluated in the 'Outcome of the evaluation of rapid diagnostic assays for specific SARS-CoV-2 antigens (lateral flow devices)' attachment.

  14. Updated the 'Outcome of the evaluation of rapid diagnostic assays for specific SARS-CoV-2 antigens (lateral flow devices)' document to add lateral flow devices that have passed 3a validation.

  15. Added attachments 'Coronavirus test device authorisations operating process for SARS-CoV-2 tests' and 'Private testing desktop review (stage 2): operating process for SARS-CoV-2 tests'.

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

  17. Updated the 'Validated technology' table in 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests' to add 3 new tests: Certest Biotech Viasure qRT-PCR, Randox Rapid PCR and Thermo Fisher Taqpath PCR.

  18. Updated 'Outcome of the evaluation of rapid diagnostic assays for specific SARS-CoV-2 antigens (lateral flow devices)' to add 5 more lateral flow devices that have passed 3a validation.

  19. 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.

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

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

  22. Updated the attachment 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests' to update the products in the pipeline table.

  23. Updated the 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests' document to add new validated technology, 'DNANudge'.

  24. 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.

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

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

  27. 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'.

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

  29. 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'.

  30. 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.

  31. 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.

  32. Updated the 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests' document to add a new validated technology, Abbott.

  33. Updated the 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests' document to delete a validated technology (Latus) and add a new validated technology (Nonacus).

  34. 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.

  35. 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.

  36. 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'.

  37. 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.

  38. 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'.

  39. 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.

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

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

  42. 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.

  43. 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.

  44. First published.