US recalls lateral flow tests amid ‘significant’ accuracy concerns

The FDA has instructed US citizens to stop using the tests amid “significant concerns that the performance of the test has not been adequately established, presenting a risk to health”.

Ian Snug
14 June 2021
Leicester, United Kingdom. April 15 2021. Home testing kit for school children and NHS staff, also called Lateral Flow tests for Covid 19, for testing at home.

The same tests have been used by UK hospitals, care homes and schools since last year to reduce asymptomatic transmission of the virus.

The United States Food and Drug Administration (FDA) has raised concerns about the accuracy of the Innova rapid self-administered lateral flow tests.

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The FDA has instructed US citizens to stop using the tests amid “significant concerns that the performance of the test has not been adequately established, presenting a risk to health”.

A letter issued to Innova by the FDA explained that the US had concerns around a lack of market authorisation and the reported “Clinical Performance” of the tests.  It is concerned that the test may be providing false-positive and false-negative results and therefore posing an increased risk to the public.

It explained that while the manufacturer “claimed a Relative Sensitivity of 96%”, the claims appear  “unsupported by any clinical data including both clinical performance data submitted to FDA in your Emergency Use Authorization (EUA) request for the SARS-CoV-2 Antigen Rapid Qualitative Test and in published reports of clinical studies of the SARS-CoV-2 Antigen Rapid Qualitative Test.”

The Innova Sars-CoV-2 Antigen Rapid Qualitative Test, which delivers results within 30 minutes without the need for processing in a laboratory, has been used by UK hospitals, care homes and schools since last year to reduce asymptomatic transmission of the virus.

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A full risk assessment.

US citizens have been instructed to “Destroy the tests by placing them in the trash ” or return them to the manufacturer.  However, the agency does admit that it has not received reports of injuries or death associated with the use of the test.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a special market authorisation for the Innova test last year.

“We are aware of the FDA communication,” the MHRA director of devices Graeme Tunbridge admitted.

“The MHRA are reviewing all available information and are working closely with NHS Test and Trace to ensure that a full risk assessment is undertaken, as is our normal process, to understand any implications for products being used in the UK. Patient safety is our main priority and we will issue safety information as and when necessary.”

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An Innova spokesperson responded to the news; “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 is confident about the quality of its product.”

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