Guidance

Coronavirus (COVID-19) serology and viral detection tests: technical validation reports

Findings from technical validations and in-service valuations reviewed by the Technical Validation Group.

• From: UK Health Security Agency
• Published: 7 December 2020
• Last updated: 18 February 2022
  Show all updates

  1. 18 February 2022

     Added Desktop Validation Report for Q-POC and added link to previous reports.

  2. 1 December 2021

     Updated to add technical validation report for Cepheid Xpert® Xpress SARS-CoV-2 assay.

  3. 21 September 2021

     Added technical validation report for Roche Cobas SARS CoV-2 + Influenza A/B for the Cobas Liat System.

  4. 12 August 2021

     Technical validation report added for Roche Cobas SARS CoV-2 Real-Time PCR.

  5. 10 August 2021

     Updated 'BD Veritor System' report so the name of the analyser has been changed to BD Veritor on page 2, and the figures in the Table 3 have been corrected.

  6. 23 July 2021

     Updated to add reports on 2 new tests: BD Veritor System and VMD Health (UK) and Alveo Technologies Inc.: be.well™ COVID-19 test.

  7. 3 June 2021

     Updated to add reports on 3 new tests: Certest Biotech Viasure qRT-PCR, Randox Rapid PCR and Thermo Fisher Taqpath PCR.

  8. 15 April 2021

     Updated 'DNANudge: COVID-19 nudge test' report to include an explanatory sentence that confirms the manufacturer's instructions for use were followed, and to add an appendix (2 tables that break down the results of the validation and add context).

  9. 6 April 2021

     Added a new technical validation report for DNANudge.

  10. 18 March 2021

      Replaced 'LumiraDx: POC rapid COVID-19 Ag test' report (with updated results).

  11. 3 February 2021

      Replaced 'Nonacus: VirPath Sars-CoV-2 Multiplex qRT-PCR: qRT-PCR' report (with updated results) and added 2 new reports,'LumiraDx: POC rapid COVID-19 Ag test' and 'Primer Design Ltd: PROmate direct: qRT-PCR'.

  12. 8 January 2021

      Added a new technical validation report (Abbott).

  13. 8 January 2021

      Deleted the Latus validation report and added the Nonacus report.

  14. 7 January 2021

      Added a new technical validation report (Latus).

  15. 23 December 2020

      Added Oxford Nanopore: LamPORE: RNA RT-qPCR validation report.

  16. 16 December 2020

      Add a new technical validation report (QuantuMDx).

  17. 7 December 2020

      First published.

Documents

Desktop Validation Report for Q-POC

HTML

Details

These technical validation reports are summarised in the validated technology table in the national technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests.

Previous reports were published by the Department of Health and Social Care (DHSC) and can be accessed via the national archives.