At-home Covid-19 antibody tests can put people at risk and mislead the public, health experts have warned.
The Royal College of Pathologists has written to Health Secretary Matt Hancock to call for tighter regulations over the have-you-had-it tests.
Officials have yet to approve any at-home antibody test for use, despite promising such kits were days away from being validated back in March.
Only NHS workers and care staff, as well as some patients in hospital and care home residents, can get their blood checked for signs of past infection.
Several different DIY antibody tests were available before regulators clamped down on the kits in May over fears finger-prick blood may not be as accurate.
But Professor Jo Martin, of the RCP, said that they were ‘concerned’ such devices, intended solely for professional use, were being offered for sale.
She warned antibody tests were being offered to consumers ‘without the required reassurance of appropriate laboratory or professional back up’.
Professor Martin said: ‘The use of these for unsupervised self use test falls outside current regulations, and can mislead the public and put individuals at risk.
‘We want everyone to be assured about the tests they receive in healthcare, or that they purchase.
‘We want to make sure that not only are they are of good quality, but they give the right result and the result is properly readable – they are appropriately ”useable”.’
A senior health body has warned the Government about the risks associated with the selling Covid-19 antibody testing devices directly to the public. Pictured is a worker demonstrating the use of a coronavirus 10-minute blood test
Antibody tests have been a controversial subject for months after the Government first pledged them to the public in March but rowed back on its decision.
Many tests turned out to be inaccurate and even if results are accurate, scientists still aren’t sure how to interpret them because people may not develop immunity.
The tests work by screening a small blood sample to look for antibodies – disease-fighting substances made by the immune system that are specific to one illness.
If Covid-specific antibodies are present in someone’s blood, it means they have been infected with the virus in the past and fought it off.
Several sellers have stopped selling their at-home antibody tests following the Government’s decision to clamp down on them in May.
Babylon Health, who manufactured an at-home test, announced on their website that all testing would be paused after the government asked that all Covid-19 antibody testing from finger-prick blood samples be paused.
The website goes on to outline that the government wants to ensure that blood taken from a home finger-prick sample shows the same levels of accuracy as a sample taken in a clinic.
It was sparked after Superdrug announced it was going to sell tests for £89 after its testing service was shut down by regulators in May.
The retailer changed its service to take blood from veins instead of relying on finger-pricks, which officials say isn’t proven to be accurate.
The tests, which cost £89 each, use kits developed by the company Abbott, which supplies the most accurate antibody test currently used by the Government.
Twenty-eight Superdrug clinics around the UK have nurses trained to draw blood so it can be analysed to look for signs of past Covid-19 infection. But the retailer is now selling the kits as a walk-in service and customers must register online first.
Antibody tests are currently a ‘class one’ medical device – meaning that companies are allowed to self-certify their tests as effective and immediately put them on the market.
However, tests for HIV and pregnancy are classed as ‘annex two’ on the European directive for medical devices – meaning that companies have to provide certified information about the efficacy of their tests.
Jon Deeks, a professor of biostatistics at the University of Birmingham, told the BBC: ‘These regulations aren’t fit for purpose and don’t protect the public from bad tests.
‘If you can get a CE mark [indicating compliance with the relevant legislation] for a bad test as there is no scrutiny on whether it works, it is just a marketing claim that is registered and we are left in a Wild West of antibody testing.
‘For drug licensing the onus is on the companies to go through clinical trials. We need that same obligation to apply for testing devices like the Covid antibody tests as well.’
He added that evaluations of tests should be added to pre-registers for clinical trials in order to stop manufacturers from reporting on only the most favourable results.
A Department of Health and Social Care official said action is being taken to enforce tough regulations on at-home antibody tests.
The spokesman – who insisted that antibody testing was an ‘important part of our strategy’ – added that some 47,000 tests have been seized.
And they added: ‘We do not yet know whether antibodies indicate immunity from reinfection with coronavirus or if they prevent transmission.’
Tests made by pharmaceutical heavyweights Roche and Abbott are currently being used to map the outbreak among the population.
BBC’s Newsnight reported an analysis of 41 antibodies tests sold to the public in Britain showed almost a third had inaccurate and incomplete information.
It comes after researchers found that large numbers of people who suffered from coronavirus could be being wrongly diagnosed as Covid free.
The Oxford University study of more than 9,000 healthcare workers found that significant numbers of people had received negative test results despite being likely to have already contracted Covid-19.