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

Optigene: Genie HT and Genie III: RNA RT-LAMP on swabs PDF, 140KB, 14 pages This file may not be suitable for users of assistive technology. Request an accessible format. If you use assistive technology (such as a screen reader) and need aversion of this document in a more accessible format, please email publications@dhsc.gov.uk.Please tell us what format you need. It will help us if you say what assistive technology you use. Optigene: Genie HT and Genie III: RNA RT-LAMP on saliva PDF, 136KB, 14 pages This file may not be suitable for users of assistive technology. Request an accessible format. If you use assistive technology (such as…

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Guidance: Assessment and procurement of coronavirus (COVID-19) tests

Published 3 June 2020 Last updated 8 January 2021 +show all updates 8 January 2021 Updated the 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests' document to add a new validated technology, Abbott. 8 January 2021 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). 7 January 2021 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. 23 December 2020 Updated 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19)…

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

Optigene: Genie HT and Genie III: RNA RT-LAMP on swabs PDF, 140KB, 14 pages This file may not be suitable for users of assistive technology. Request an accessible format. If you use assistive technology (such as a screen reader) and need aversion of this document in a more accessible format, please email publications@dhsc.gov.uk.Please tell us what format you need. It will help us if you say what assistive technology you use. Optigene: Genie HT and Genie III: RNA RT-LAMP on saliva PDF, 136KB, 14 pages This file may not be suitable for users of assistive technology. Request an accessible format. If you use assistive technology (such as…

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Guidance: Assessment and procurement of coronavirus (COVID-19) tests

Published 3 June 2020 Last updated 8 January 2021 +show all updates 8 January 2021 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). 7 January 2021 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. 23 December 2020 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…

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Guidance: Assessment and procurement of coronavirus (COVID-19) tests

Published 3 June 2020 Last updated 7 January 2021 +show all updates 7 January 2021 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. 23 December 2020 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. 23 December 2020 Added Oxford Nanopore: LamPORE: RNA RT-qPCR to validated…

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

Optigene: Genie HT and Genie III: RNA RT-LAMP on swabs PDF, 140KB, 14 pages This file may not be suitable for users of assistive technology. Request an accessible format. If you use assistive technology (such as a screen reader) and need aversion of this document in a more accessible format, please email publications@dhsc.gov.uk.Please tell us what format you need. It will help us if you say what assistive technology you use. Optigene: Genie HT and Genie III: RNA RT-LAMP on saliva PDF, 136KB, 14 pages This file may not be suitable for users of assistive technology. Request an accessible format. If you use assistive technology (such as…

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Guidance: Coronavirus (COVID-19) lateral flow tests waste codes

Published 18 December 2020 Last updated 24 December 2020 +show all updates 24 December 2020 Updated table of lateral flow test waste codes with following updates: likely management route/waste hierarchy made hierarchy of options clearer; Health Technical Memoranda (HTM) 07 01 Packaging made hierarchy of the packaging to be used clearer; likely management route/waste hierarchy added energy from waste as the first option for the disposal of personal protective equipment. 18 December 2020 First published. Source link

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Guidance: Assessment and procurement of coronavirus (COVID-19) tests

Published 3 June 2020 Last updated 23 December 2020 +show all updates 23 December 2020 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. 23 December 2020 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'. 22 December 2020 Updated 'National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests' to reflect the number…

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SARS-CoV-2 lateral flow antigen tests: evaluation of VUI-202012/01

Working with academic collaborators at the University of Oxford, PHE Porton Down has been evaluating the performance of lateral flow devices (LFDs) since mid-August 2020. Over 60 have been considered to date, approximately 30% of which have progressed to extended evaluation on clinical samples at Phase 3. Source link

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Guidance: Assessment and procurement of coronavirus (COVID-19) tests

Published 3 June 2020 Last updated 23 December 2020 +show all updates 23 December 2020 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'. 22 December 2020 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. 17 December 2020 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…

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