RE: View Yesterdays Webinar11 Jun 2020 10:26
Pillar 3 approach to antibody test devices
• The Government is currently pursuing two main types of antibody test device:
• Lab-based tests (ELISA or other immunoassay) for use within NHS and other laboratories.
• Self-use finger-prick tests (lateral-flow tests) for use within a home or community setting.
• MHRA has published target product profiles online outlining the specifications we require for different products types.
• We have been scanning the market for available solutions which meet our specifications, and want to hear from industry
about testing options. We have signed contracts with several assay providers and are in negotiations with other suppliers.
• We are also backing efforts to develop a homegrown test. A business consortium, UK Rapid Test Consortium (UK-RTC),
including Oxford University, Abingdon Health, BBI Solutions and CIGA Healthcare has launched, in order to design and
develop a new lateral flow test.
Deployment to date
• The Health Secretary announced in May that the Government would roll out lab based testing for NHS and care staff, as well
as patients and care residents based on clinical advice.
• Testing using existing NHS pathology lab infrastructure is up and running with an initial capacity of 40,000 tests a day.
• For care staff, antibody testing will be rolled out in a phased way across regions in England. We are working with local leaders
in Greater Manchester to design the initial rollout and we expect to start testing soon. We will then develop plans with local
leaders to implement testing in the rest of England, based on local needs and their ability to combine this with swab testing.
• Public messaging on what having a positive antibody test means is clear – don’t assume any level of immunity and continue
to follow government advice on social distancing
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