Transparency data

Documents related to the exceptional use authorisation

Published 21 March 2024

In late 2020, the UK was continuing to address the serious public health crisis of the coronavirus pandemic.

The primary mode of SARS-CoV-2 testing was using reverse transcription polymerase chain reaction (RT-PCR) and predominantly the national COVID-19 testing programme prioritised those with symptoms in the community.

New asymptomatic testing initiatives were being developed and pilots, such as the world’s first city-wide, voluntary COVID-19 rapid antigen testing pilot in Liverpool were being implemented. These were restricted to professional use lateral flow devices (LFD), where a person could self-sample but processing and results recording was carried out by trained professionals, which were the only LFDs available at the time.

Reports suggested that around 1 in 3 individuals infected with coronavirus did not display symptoms. An effective asymptomatic testing programme to identify positive cases sooner and to break hidden chains of transmission was considered central to the public health response.

Availability of a self-administered rapid test was viewed as essential to the upscaling of the asymptomatic testing programmes. To offer mass testing to the general public at pace, which included testing asymptomatic infectious people, testing needed to be delivered at a much greater scale than was possible through the laboratory network for PCR testing alone.

The Department of Health and Social Care (DHSC) ^{[footnote 1]} identified Innova as the only supplier at that time with a test whose performance had been scientifically validated to perform at the required level ^{[footnote 2]} that could also produce volumes at the amount and speed needed and was prepared to work flexibly on the size and specification of the product. The UK government through DHSC took the step of becoming the legal manufacturer of self-test LFDs produced by Innova Biotime ^{[footnote 3]}.

The validation work carried out at Public Health England (PHE), Oxford University and DHSC/NHS Test and Trace (NHS TT) was compiled by DHSC/NHS TT to produce relevant evidence and documentation for an application for an exceptional use authorisation (EUA) for the test. Documents submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) for the Innova/DHSC EUA application for self-use LFDs in December 2020 are listed below.

Due to the urgency of obtaining the EUA, some service evaluation studies reported in the documentation were interim analyses and have since been published in full.

For latest evidence on device performance, refer to the more recent publications. These include all data included in the EUA submission.

The EUA submission

Download the EUA submission

EAU submission documents

The following documents were submitted to the MHRA as part of the EUA submission:

1. Estimating the extent of asymptomatic COVID-19 and its potential for community transmission: systematic review and meta-analysis

2. Innova IFU (original Innova instructions for use)

3. DHSC COVID-19 self-test IFU v1.06 (DHSC COVID-19 self-test instructions for use)

4. NHS-COVID-19 self-test kit 3T-195-80-30mm-201212.pdf (design specifications for NHS COVID-19 self-test kit packaging containing 3 lateral flow tests)

5. NHS-COVID-19 self-test kit 7T-195-160-30mm-201212.pdf (design specifications for NHS COVID-19 self-test kit packaging containing 7 lateral flow tests)

6. Single dose buffer specification drawing

7a. Swab HH (packaging, registration, certificate, IFU) (HH swab instruction for use)

7b. Swab HH (packaging, registration, certificate, IFU) (HH swab packaging)

8a. Swab MJ (certificate, packaging, registration, IFU) a) MJ swab instruction for use

8b. Swab MJ (certificate, packaging, registration, IFU) b) MJ swab packaging

9. COVID-19: Innova lateral flow test is not fit for ‘test and release’ strategy, say experts

10. Differential occupational risks to healthcare workers from SARS-CoV-2

11. SAR-R-011 risk management report: Innova A01 (report for the risk management of SARS-CoV-2 rapid antigen test produced by Innova)

12. Test to find at home: schools pilot (proposed schools pilots)

13. DHSC risk log V1 for LFD device for SARS-CoV-19: approved (risk log)

14. Duration of infectiousness and correlation with RT - PCR cycle threshold values (peer-reviewed manuscript evaluating the PCR cycle threshold values reached in infected cases after illness or symptoms onset and the relationship between ct and virus recovery. Major conclusions include 10-day infection control measures for infected cases after onset of symptoms, and that asymptomatic and presymptomatic persons are likely to be a source of infectious virus)

15. Rethinking COVID-19 test sensitivity: a strategy for containment (peer-reviewed manuscript proposing a regimen of regular testing strategy for identication and containment of infected people including asymptomatics to prevent the SARS-CoV-2 spread within community)

16. LFD IFU study protocol (study protocol for a remote based summative study to evaluate the IFU used with the LFD COVID-19 virus test kit)

17. LFD IFU usability study (report documenting the results of a summative human factors study to evaluate the LFD COVID-19 virus test kit and IFU)

18. IFU recommendation ASJ-20-1317 (summary of recommendations to improve the instructions for use for self-test LFD)

19. NHS TT acceptability and usability survey version 1 (report assessing the acceptability and useability of the Innova SARS-CoV-2 antigen rapid qualitative test by means of a self-reported cross-sectional questionnaire)

20. SARS-R057 SARS-CoV-2 antigen (transport and accelerated aging stability report)

21. SARS-R059 SARS-CoV-2 antigen (stability study report)

22. SARS-R050 new buffer model (single use extraction solution: stability research protocol)

23. SARS-R051 new buffer model (new buffer: stability research protocol)

24. SARS-R060 COVID-19 self-test kit (stability study report)

25. SARS-R061 COVID-19 self-test kit (transport and accelerated aging stability report)

26. At home self-testing of teachers

27. Quantifying SARS-CoV- 2 transmission

28. Effectiveness of isolation, testing, contact tracing, and physical distancing

29. SARS-CoV-2 viral dynamics in acute infections

30. Test sensitivity is secondary to frequency

31. Daily testing 24 November 2020

32. Head-to-head comparison of self-swabbing (anterior nasal) versus professionally-collected nasopharyngeal swab using a rapid test  (Linder)

33. 140720 evidence report COMBI021 (service evaluation evidence report; data collated in full report published online)

34. 20200424 evidence report SE SWTC001 version 5 (service evaluation evidence report; data collated in full report published online)

35. 20200509 evidence report SE SWTC003 version 3 (service evaluation evidence report; data collated in full report published online)

36. 140720 evidence report TS5 34A (service evaluation evidence report; data collated in full report published online)

1. The EUA application was made by DHSC which was the sponsoring department of NHS TT. NHS TT was one of the predecessor organisations of the UK Health Security Agency (UKHSA) which was established in April 2021. ↩

2. All lateral flow devices that DHSC procures undergo an extensive clinical evaluation by Oxford University and UKHSA Porton Down to confirm that the lateral flow device displays performance characteristics desirable for mass population, community based testing. The desirable performance characteristics are very high specificity and very high sensitivity against viral loads associated with infectiousness. ↩

3. The duties of legal manufacturer was transferred to UKHSA on its establishment. ↩