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While the human toll of the disease has been terrible, IVD makers also report there have been some positive developments, as demand has spiked and familiarity with testing has grown.

The testing program is part of a strategy to lift restrictions in the UK. 

During laboratory validation, the test showed sensitivity against high viral loads of 97.1 percent and specificity of 99.9 percent, the UK government said.

SureScreen's test will be deployed in educational settings, as well as for the testing of National Health Service and care home staff.

Residents and workers in the city will be tested with PCR, new lateral flow, and LAMP tests as the country faces a wave of new coronaviruses cases and a lockdown.

Laboratories at University College London, Imperial College London, Queen Mary University of London, and King's College London will all contribute to the effort.

The test could also be used to assess vaccine effectiveness, should a vaccine become available.

While the guidance was welcome after years of uncertainty, regulatory experts say it does not provide enough detail for IVD manufacturers. 

The new "moonshot" plan, as the government refers to it, will be based on using rapid testing of nasal swabs and saliva using platforms with a turnaround time of 20 to 90 minutes.

IVDs in the future will require certification in England, Scotland, and Wales, while companies will still be able to sell tests in Northern Ireland under existing EU regulations.

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