US raises concerns over Innova Covid test used in UK

The FDA said the performance of the test "has not been adequately established."

US raises concerns over Innova Covid test used in UK

The UK’s health department has said it has confidence in lateral flow tests – despite concerns being raised by the US Food and Drug Agency (FDA) over the use of a test made by Innova.

In a statement, the FDA said that it had “significant concerns” over the Innova SARS-CoV-2 Antigen Rapid Qualitative Test.

It said that the performance of the test “has not been adequately established, presenting a risk to health”, and warned the public to stop using it for diagnostic use.

The FDA stated that labelling distributed with “certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during the clinical studies of the tests”.

It also noted that the test has not been authorised, cleared, or approved by the FDA for commercial distribution or use in the United States, as required by law.

The tests have been used in the UK as part of the UK Government’s ‘Operation Moonshot’ as part of efforts to ramp up mass testing.

A Department of Health and Social Care spokeswoman said: “The Innova test has already gone through the UK’s rigorous Porton Down assessment process, and we have a robust quality assurance process in place.

“We have confidence in lateral flow tests, which help us identify people without symptoms but who could pass the virus to others – helping break the chains of transmission.”

In a statement, Innova said that it is “confident about the quality of its product”.

The statement read: “Innova is of course committed in making the most equitable test with the highest quality, and none of the inspectional observations in the FDA letter concern the performance of the test.

“The Innova rapid antigen test has been widely used, studied, tested, scrutinised and analysed with data supporting the efficacy of the test from the largest mass testing programme out of the UK.

“Innova understands the FDA’s health risk concern for the US market as they have not evaluated or authorised the Innova test in the US.

“In simple terms, the regulator won’t confirm a product is safe to use until it has evaluated and authorised a product itself.

“Innova has voluntarily recalled those products that it distributed to its employees, clinical studies and some customers for evaluations purposes. Innova is confident about the quality of its product.”

A Scottish Government spokesperson said:

“There is a robust quality assurance programme in place for Innova tests which are currently used for all lateral flow testing in Scotland and have also already gone through the UK National Testing Programme’s rigorous Porton Down assessment process.

“We have confidence in lateral flow tests which have been available to anyone in Scotland who wants one since April 26 and are vital in helping break the chains of transmission, by helping us identify people without symptoms but who could pass on the virus.

“As we have said consistently from the outset, no test is 100% accurate, and testing on its own, does not reduce transmission. It only helps stop transmission through the actions taken following the result.”

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