The UK’s healthcare regulator has expressed concern to the government that its multibillion-pound mass testing programme is “a stretch” of the authorised use of rapid tests, the Guardian has learned.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the lateral flow devices to be used to find coronavirus cases but not to act as a “green light” for people who test negative to enjoy greater freedoms.
The regulator is concerned that people who test negative will be given false reassurance by their result and will let down their guard if they believe they are Covid-free.
There is very little data to show how well the Innova lateral flow devices detect the virus when used as a self-test by someone who has no symptoms. They are being used by millions of people a week in England under the government’s universal testing programme.