A 20-second COVID-19 test will launch in Britain after regulators accepted its registration, the product’s distributor said on Friday, heralding a testing system it said could be used in airports, sports venues and businesses.
Rapid tests are seen as a key plank of Prime Minister Boris Johnson’s road map out of lockdown, but concerns have been expressed about the accuracy of existing lateral flow devices.
The Virolens test, which is made by British startup iAbra and TT Electronics, has been piloted at Heathrow Airport, and uses swabs of saliva.
Histate, which is distributing the test, said it would launch with immediate effect after the Medicines and Healthcare products Regulatory Agency (MHRA) accepted the registration of the product, and the company said it was hoping for a wider rollout in coming months.
The MHRA does not issue approvals for COVID-19 tests in the way it does for vaccines, having determined they are effective, but registers medical devices with a certification mark if they meet legal criteria, are safe and are made to the standard specified by the manufacturer for the stated purpose.
Histate said trials had indicated the test had 98.1 per cent sensitivity, meaning it returns few false negatives, and 99.7 per cent specificity, meaning few false positives.
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