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.

Documents

Optigene: Genie® HT and Genie® III: RNA RT-LAMP on swabs

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Optigene: Genie® HT and Genie® III: RNA RT-LAMP on saliva

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Optigene: Genie® HT and Genie® III: Direct RT-LAMP on swabs

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Optigene: Genie® HT and Genie® III: Direct RT-LAMP on saliva

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Diagnostics for the Real World: SAMBA II SARS-COV-2 Test: POCT combined extraction and RT-PCR

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LGC Group Ltd: End- point PCR (EPCR): Extracted RT-PCR with endpoint detection

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LumiraDx: POC rapid COVID-19 Ag test

DNANudge: COVID-19 nudge test

Certest: Viasure SARS CoV-2 Real-Time PCR

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Randox: COVID-19 qPCR assay

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Thermo Fisher: TaqPath™ COVID-19 CE-IVD

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BD Veritor System

VMD Health (UK) and Alveo Technologies Inc.: be.well™ COVID-19 test

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Roche Cobas SARS CoV-2 Real-Time PCR

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.

Published 7 December 2020
Last updated 1 December 2021 + show all updates
  1. Updated to add technical validation report for Cepheid Xpert® Xpress SARS-CoV-2 assay.

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

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

  4. 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.

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

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

  7. 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).

  8. Added a new technical validation report for DNANudge.

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

  10. 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'.

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

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

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

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

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

  16. First published.