Background
Since its establishment in August 2020, the joint UK Health Security Agency (UKHSA) Porton Down and University of Oxford SARS-CoV-2 lateral flow antigen test validation cell has evaluated over 160 lateral flow devices that have been referred by the Department of Health and Social Care.
Approximately 30% of the tests that were referred for validation met the standards for phase 2 validation, which are set out in the protocol for evaluation of rapid diagnostic assays for specific SARS-CoV-2 antigens.
UKHSA Porton Down subsequently performed phase 3 testing to assess whether the lateral flow devices that passed phase 2 displayed performance characteristics desirable for mass population, community-based testing.
The desirable performance characteristics are:
- very high specificity
- very high sensitivity against viral loads associated with infectiousness
The lateral flow devices that display the desirable performance characteristics are summarised in table 1 below.
Table 1: summary of lateral flow devices that have passed phase 3a validation
| Lateral flow device | Status | Date evaluation completed |
|---|---|---|
| Abbott Panbio COVID-19 Ag Rapid Test Device | Pass | 29 September 2020 |
| ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test | Pass | 19 February 2021 |
| Ameda AMP Rapid Test SARS-CoV-2 Ag | Pass | 12 March 2021 |
| Anhui DeepBlue COVID-19 Antigen Test Kit | Pass | 23 October 2020 |
| Arista COVID-19 Antigen Rapid Test | Pass | 25 June 2021 |
| Assure Tech Ecotest COVID-19 Antigen Nasal Test Kit (Biosafe Nasal ‘Pen’ Device) | Pass | 14 January 2022 |
| Assure Tech Ecotest COVID-19 Antigen Rapid Test Device | Pass | 20 July 2021 |
| Beijing Kewei COVID-19 Antigen Rapid Test Kit | Pass | 21 May 2021 |
| BHM COVID-19 Antigen Sealing Tube Test Strip | Pass | 14 January 2022 |
| Biopanda COVID-19 Rapid Antigen Test | Pass | 25 June 2021 |
| Bioperfectus Technologies Novel Corona Virus Ag Rapid Test Kit | Pass | 5 February 2021 |
| Biosynex COVID-19 Ag+ BSS | Pass | 29 September 2021 |
| Biozek COVID-19 Antigen Rapid Test Cassette (Swab) | Pass | 29 September 2021 |
| Core Tests COVID-19 Ag Test | Pass | 17 December 2021 |
| DenScreen SARS CoV-2 Rapid Antigen Test: Non-Invasive Nostril Swab | Pass | 3 August 2021 |
| DNA Diagnostic COVID-19 Antigen Detection Kit | Pass | 20 January 2021 |
| Excalibur Rapid SARS-CoV-2 Antigen Test Card | Pass | 22 January 2021 |
| Fortress Diagnostics Coronavirus Ag Rapid Test | Pass | 13 November 2020 |
| GenSure COVID-19 Antigen Rapid Test Kit | Pass | 25 June 2021 |
| Getein Biotech One Step Test for SARS-CoV-2 Antigen | Pass | 10 March 2021 |
| Goldsite SARS-CoV-2 Antigen Kit (Colloidal Gold) | Pass | 8 July 2021 |
| Hangzhou Clongene Biotech COVID-19 Antigen Rapid Test Cassette (Nasal Swab) | Pass | 29 September 2021 |
| Hughes Veritas Rapid Antigen Test for SARS-CoV-2 | Pass | 21 May 2021 |
| Humasis COVID-19 Ag Test | Pass | 25 June 2021 |
| Innova (Xiamen Biotime) SARS-CoV-2 Antigen Rapid Qualitative Test | Pass | 11 September 2020 |
| Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | Pass | 17 December 2021 |
| Kisshealth Rapid COVID-19 Self-Test Antigen Lateral Flow Device | Pass | 17 December 2021 |
| Konsung COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | Pass | 8 July 2021 |
| Liming Bio StrongStep SARS-CoV-2 Antigen Rapid Test | Pass | 2 March 2021 |
| Lyher Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) | Pass | 21 May 2021 |
| Mediport COVID-19 Antigen Rapid Test Kit | Pass | 25 June 2021 |
| NADAL COVID-19 Ag plus test | Pass | 17 December 2021 |
| Nantong Diagnos Biotechnology COVID-19 Ag Test | Pass | 21 January 2021 |
| Orient Gene / Healgen Coronavirus Ag Rapid Test (swab) | Pass | 2 October 2020 |
| Roche SARS-CoV-2 Rapid Antigen Test Nasal / Self Test Nasal | Pass | 21 May 2021 |
| Roche SD Biosensor Standard Q COVID-19 Ag Test | Pass | 2 December 2020 |
| Roche SD Biosensor Standard Q COVID-19 Ag Saliva Test | Pass | 9 February 2021 |
| Shenzhen YHLO GLINE-2019-nCoV Ag test | Pass | 25 June 2021 |
| Surescreen SARS-CoV-2 Antigen Rapid Test Cassette | Pass | 2 December 2020 |
| Surescreen SARS-CoV-2 Antigen Rapid Test Cassette v2 | Pass | 15 March 2021 |
| Surge COVID-19 Antigen Test Kit | Pass | 3 August 2021 |
| Tigsun COVID-19 Antigen Rapid Test | Pass | 29 September 2021 |
| Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) | Pass | 25 June 2021 |
| Wuhan EasyDiagnosis COVID-19 (SARS-CoV-2) Antigen Test Kit | Pass | 21 May 2021 |
| Xiamen Boson Biotech Rapid SARS-CoV-2 Antigen Test Card | Pass | 29 September 2021 |
| ZandCell COVID-19 Antigen Test | Pass | 18 March 2021 |
| Zhuhai ENCODE - SARS-COV-2 Antigen Rapid Test Device | Pass | 29 September 2021 |
EU health preparedness:
A common list of COVID-19 rapid antigen
tests;
A common standardised set of data to be
included in COVID19 test result certificates; and
A common list of COVID-19 laboratory based
antigenic assays
