A rapid COVID-19 antibody test developed by diagnostics firm Omega has reached the significant design freeze stage which means it is ready for regulatory approval.
The lateral flow device, which allows people to test for antibodies at home with almost instant results, will now move on to the verification and validation which should lead to regulatory approval.
This device will be important in establishing whether people have been exposed to COVID-19.
Omega, based in Alva, near Alloa, is part of the UK Rapid Test Consortium (RTC-UK) formed under a Memorandum of Understanding with Abingdon Health, BBI Solutions, CIGA Healthcare and the University of Oxford.
Abingdon Health is to complete verification, validation and transfer the manufacturing protocols to consortium members, allowing Omega to demonstrate enough can be produced to meet UK demand. This is expected to be completed by the end of August.
Design freeze means agreed specifications for the test have been met. Omega plans to produce 100,000 tests a week, increasing to 200,000 by the end of September. The consortium began working on the test in early April.
RTC-UK says its pilot batch of the test showed a 98.6% accuracy rate.
Colin King, CEO of Omega, said:
"This key milestone achievement in such a short timescale is a credit to the hard work put in by the consortium. We can now look forward with greater confidence in bringing this important test to market to support the UK and devolved Governments in their fight against this pandemic."
Kenneth Gibson MSP added:
“While it is heartening that no coronavirus deaths were recorded over five days in Scotland over the past week, the development of these home antibody tests is crucial to help suppress the virus. It is great to see an innovative Scottish firm be part of the solution.
“As people slowly re-emerge into public places and shops, we are exposing ourselves again to the virus and a second wave must be anticipated.”
Omega also has a three-year agreement to mass produce three COVID-19 tests for life sciences firm Mologic at its bases in Alva and Cambridgeshire.