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Dear MP
Thank you for your correspondence of 28th September on behalf of your constituent about testing for COVID - 19.
I am grateful to you for raising his concerns.
The performance data Avacta published on its AffiDX-CoV-2 antigen lateral flow device (LFD) test looks positive. However, we cannot comment on the validation status of individual LFDs.
We are committed to boosting UK manufacturing and demonstrated with the award of a contract for 20 million devices to Derby - based test manufacturer SureScreen Diagnostics. These lateral flow device (LFD) tests were the first British tests to be validated in the laboratory by Public Health England.
Collaboration between industry and Government continues to be a priority, and we are hugely grateful to all the manufacturers and suppliers that have come forward to offer their assistance in producing LFD tests.
The valuable partnerships being created with companies such as SureScreen Diagnostics are further contributing to the resilience of the UK, both through supporting the work of UK Diagnostics manufacturers and by harnessing the possibilities opened up by rapid regular testing.
Our Dynamic Purchasing System, a procurement tool that allows qualifying suppliers to compete for contracts, will diversify the supply the supply of LFD tests through fair and transparent competition. Further information can be found at www.gov.uk by searching for- national technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests.
To be purchased by the department, LFD tests need to be validated by Porton Down and must have regulatory approval in the form of either an exceptional use authorisation (EUA) or a European conformity (CE) Mark. None of the products for self - testing with Medicines and Health care products Regulatory Agency EUA approval or a CE Mark is currently manufacturers in the UK.
The joint Porton Down and University of Oxford team has developed a rigorous validation approach, which can be found at www.gov.uk by searching for protocol for evaluation of rapid diagnostic assays for specific SARS-CoV-2 antigens (lateral flow devices).
The current validation process consists of three phases of assessment of increasing stringentcy. Phase 3a is a validation against clinical samples. Successful completion of this final phase means a product has demonstrated suitable performance and is therefore eligible for procurement.
A number of UK products have been through Porton Down validation and have passed phase 3a validation. None of these has yet achieved regulatory approval to allow them to be used in the settings we require. However, work is underway to secure regulatory approval for the suppliers of these products, and we hope that this will be completed successfully in the coming months.
I hope this reply is helpful, Maggie Throup, Parliamentary Under Secretary of State for Vaccines and Public Health.
Make of it what you will, but I thought it was quite a positive lette