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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 — See all updates

Documents

Desktop Validation Report for Q-POC

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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.

Updates to this page

Last updated:
18 February 2022
Show all updates

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

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

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

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

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

  8. 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. Added a new technical validation report for DNANudge.

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

  11. 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. Added a new technical validation report (Abbott).

  13. Deleted the Latus validation report and added the Nonacus report.

  14. Added a new technical validation report (Latus).

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

  16. Add a new technical validation report (QuantuMDx).

  17. First published.

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