Britain extends approval for rapid COVID-19 test after U.S. rebuke

Last week FDA urged the public to stop using the test, warning its performance had not been adequately established

  
An Innova SARS-CoV-2 antigen test kit is pictured at the NHS vaccination centre, amid the coronavirus disease (COVID-19) outbreak, in Robertson House, in Stevenage, Britain January 14, 2021. Leon Neal/Pool via REUTERS

An Innova SARS-CoV-2 antigen test kit is pictured at the NHS vaccination centre, amid the coronavirus disease (COVID-19) outbreak, in Robertson House, in Stevenage, Britain January 14, 2021. Leon Neal/Pool via REUTERS

LONDON - Britain's medicine regulator on Thursday extended the emergency use approval (EUA) for Innova's lateral flow COVID-19 tests, saying it was satisfied with a review of the tests after its U.S. counterpart issued a warning about them.

Innova's tests have been approved for asymptomatic testing as part of England's test and trace system.

Last week the U.S. Food and Drug Administration (FDA) urged the public to stop using the test, warning its performance had not been adequately established. 

"We have now concluded our review of the risk assessment and are satisfied that no further action is necessary or advisable at this time," said Graeme Tunbridge, Director of Devices at the Medicines and Healthcare products Regulatory Agency (MHRA).

"This has allowed us to extend the EUA to allow ongoing supply of these LFDs over the coming months"

British Prime Minister Boris Johnson has said regular, asymptomatic testing as a big role to play in reopening the economy. However, some scientists have questioned the accuracy of the rapid tests being used in Britain, saying that they might do more harm than good. 

Public Health England has said the tests undergo rigorous validation, and can help stop outbreaks by picking up undetected cases of COVID-19.

(Reporting by Alistair Smout; editing by Michael Holden) ((alistair.smout@thomsonreuters.com; +44 207 542 7064; Reuters Messaging: alistair.smout.thomsonreuters.com@reuters.net))


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