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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鈥檚 first city-wide, voluntary 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聽viewed as聽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

EAU submission documents

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

1.

2. (original Innova instructions for use)

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

4. (design specifications for NHS COVID-19 self-test kit packaging containing 3 lateral flow tests)

5. (design specifications for NHS COVID-19 self-test kit packaging containing 7 lateral flow tests)

6.

7a. (HH swab instruction for use)

7b. (HH swab packaging)

8a.

8b.

9.

10.

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

12. (proposed schools pilots)

13. (risk log)

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

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

18. (summary of recommendations to improve the instructions for use for self-test LFD)

19. (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. (transport and accelerated aging stability report)

21. (stability study report)

22. (single use extraction solution: stability research protocol)

23. (new buffer: stability research protocol)

24. (stability study report)

25. (transport and accelerated aging stability report)

26.

27.

28.

29.

30.

31.

32.

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

34. (service evaluation evidence report; data collated in full report published online)

35. (service evaluation evidence report; data collated in full report published online)

36. (service evaluation evidence report; data collated in full report published online)