At-home Covid-19 antibody tests could put people at risk and mislead the public, health experts have warned.
The Royal College of Pathologists has written to Health Secretary Matt Hancock asking for tougher regulations on the has-you-had-it tests.
Officials have not yet had to approve a home anti-antibody test for use, despite claiming they were on such days that they were validated in March.
Only NHS workers and healthcare professionals, such as some patients in hospital and nursing home residents, can check their blood for signs of past infection.
Several different DIY antibody tests were available before regulators in May clung to the kits about fears with finger prick blood might not be so accurate.
But Professor Jo Martin, of the RCP, said they ‘provided’ such devices, intended for professional use only, were offered for sale.
She warned that antibody tests were offered to consumers ‘without the required assurance of appropriate laboratory or professional backup’.
Professor Martin said: ‘The use of this for uncontrolled self-use testing falls outside current regulations, and can mislead the public and endanger individuals.
‘We want everyone to be assured about the tests they get in health care, when they buy it.
‘We want to make sure they are not only of good quality, but they give the right result and the result is readable – they are appropriately’ ‘useful’ ‘.’
A senior health body has warned the government about the risks associated with selling Covid-19 antibody testing devices directly to the public. Pictured is a worker demonstrating the use of a 10-minute coronavirus blood test
Antibody testing has been a controversial topic for months, after the government initially promised it to the public in March, but again relied on its decision.
Many tests have been shown to be inaccurate and even if results are accurate, scientists are still unsure how to interpret them, as humans 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 for one disease.
If Covid-specific antibodies are present in someone’s blood, it means that they have been infected with the virus in the past and fought it out.
WHAT IS AN ANTIBODY TEST AND WHERE IS IT USED FROM?
Antibody tests are those that look for signs of past infection in someone’s blood.
Antibodies are substances produced by the immune system that keep memories of fighting a specific virus. They can only be made if the body is exposed to the virus by getting infection for real, or through a vaccine or some other type of special immunotherapy.
In general, antibodies produce immunity to a virus because they are re-introduced when it enters the body a second time, and defeat the bug faster than it can take and cause a disease.
An antibody test, which involves analyzing someone’s blood sample, has two purposes: to show if an individual has been infected in the past and thus can be protected against the virus, and to count these people.
Knowing that you are immune to a virus – although it is not yet known whether humans develop immunity to Covid-19 – may affect how you act in the future. Someone needs to protect themselves less when they know they are infected, for example, as medical staff may be able to return to work knowing they are not at risk.
Counting the number of people who have antibodies is the most accurate way to calculate how many people in a population already have the virus.
This can be done on a small sample of the population and scaling up the figures to give a picture of the country as a whole.
In turn, this could inform scientists and politicians how devastating a second outbreak can be, and how close the country is to herd immunity – a situation in which so many people already had the virus that it could not spread a second quickly.
Experts believe that about 60 percent exposure would be required for herd immunity against Covid-19, but the UK appears to be nowhere near that.
Early estimates suggest that 17 per cent of Londoners have the virus, along with five per cent of the rest of the country – about 4.83 million people.
This means that the virus may spread more slowly in the future, but the risk of a second outbreak and hundreds or thousands more deaths remains very real.
Several sellers have stopped selling their home antibody tests following the government’s decision to sue them in May.
Babylon announced on its website that all tests will be suspended after the government requested that all Covid-19 antibody tests of finger prick blood samples be suspended.
The government wants to ensure that blood taken from a home fingerprick sample shows the same levels of accuracy as a sample taken in a clinic.
The downward pressure was sparked after Superdrug announced it would sell testing for £ 89, which saw its testing service shut down by regulators in May.
The retailer changed its service last month to take blood from veins instead of relying on finger pricks.
Antibody testing is currently a ‘class one’ medical device – which means companies can self-certify their tests as effective and bring them to market immediately.
However, tests for HIV and pregnancy are classified as ‘Annex Two’ to the European Directive on Medical Devices – which means companies need to provide certified information on the effectiveness of their tests.
Jon Deeks, a professor of biostatistics at the University of Birmingham, told the BBC: ‘These schemes are not fit for purpose and do not protect the public from bad testing.
‘If you can get a CE mark [indicating compliance with the relevant legislation] for a bad test, because there is no control over whether it works, it’s just a marketing claim registered and we’re left in a Wild West of antibody testing.
‘For drug licensing, the onus is on companies to continue with clinical trials. We need the same obligation to apply for test devices as well as the Covid antibody tests. ‘
He added that evaluations of tests should be added to pre-trials for clinical trials to stop manufacturers from reporting only the most favorable results.
An official from the Department of Health and Social Care said action is being taken to include strict regulations on the home antibody tests.
The spokesman – who acknowledged that antibody testing was an ‘important part of our strategy’ – added that 47,000 tests had been seized.
And she added: ‘We do not yet know whether antibodies confer immunity against reinfection with coronavirus or if they prevent transmission.’
Tests conducted by pharmaceutical heavyweights Roche and Abbott are currently being used to map the outbreak among the population.
BBC’s Newsnight reported that an analysis of 41 antibody tests sold to the public in Britain showed that almost a third had inaccurate and incomplete information.
It comes after researchers found that large numbers of people suffering from coronavirus could be misdiagnosed as Covid free.
The Oxford University study of more than 9,000 health care workers found that a significant number of people had received negative test results, despite the fact that they had probably already contracted Covid-19.
ANTIBODY TESTING IN THE UK: A TIMELINE
March 19: Boris Johnson promised to make antibody tests ‘as simple as a pregnancy test’ available for people to use at home.
March 25: Sharon Peacock, public health in the UK, said the UK had purchased 3.5 million antibody tests and evaluated them with a view to making them available ‘within days’.
March 30: UK testing companies including BioSure and SureScreen said they had been approached by the government and said their services might be needed but heard nothing more.
April: In early April, the Department of Health said that PHE already had 800 blood samples to test for antibodies.
April 2: Health Secretary Matt Hancock claimed that the antibody test used on those samples at Porton Down was ‘ultra-high accuracy’, but data were never released to do so.
April 3: Universities and private labs caused outrage when they revealed that the government had rejected their offers to help with swab tests, to check who was currently suffering from the disease.
April 5: Professor Sir John Bell, of the University of Oxford, published a blog entitled ‘Trouble in testing land’, and found that no tests he had seen so far were any good. He said it takes at least a month to make one.
April 8: Professor Bell accused PHE of not being helpful and not providing enough blood samples to analyze tests with, in leaked emails seen by The Telegraph.
April 16: The New York Times reported that Britain had spent £ 16.5 million on antibody tests that it no longer wanted to use.
April 18: PHE professor John Newton warned people not to try to buy or use antibody tests that have not been approved by the government, saying ‘they could endanger you, your family, or others’.
April 20: Professor Derrick Crook, of John Radcliffe Hospital in Oxford, published a study which showed that none of the antibody tests purchased by the government were good enough to use.
April 24: Chief Medical Officer for England, Professor Chris Whitty, told MPs in the Science and Technology Committee that currently available antibody tests were good enough for population monitoring but not good enough for diagnosis.
May 1: Mologic, a British company that received £ 1 million from the government in March, revealed the early results of its anti-code test. It’s 98 percent specific and 96 percent sensitive – below the MHRA’s standard of 98/98.
May 14: The approval of Roche’s antibody test by PHE goes public, claiming that it is a ‘game changer’ and is 100 per cent accurate.
May 15: The approval of Abbott’s coronavirus test is revealed in the Daily Mail, with more claims of near-perfect accuracy and reports of millions being bought directly by Britain.
May 21: Matt Hancock announces on TV the early results of anti-hook studies being done in the UK. He said they suggest that 17 per cent of people in London had the disease, along with five per cent somewhere in the country.
May 25: The UK’s first government-supplied antibody tests are available for health workers.
May 28: Office for National Statistics publishes its first data for antibody testing. It found 60 positive results in a pool of 885 samples in England, suggesting a national infection rate of 6.78 per cent (3.7 million people).
May 29: PHE published evaluation of a third antibody test, conducted by Ortho Clinical Diagnostics, to no fanfare. It was found that 77.4 per cent are sensitive and 99.7 per cent specific.
June 4: PHE publishes the most comprehensive anti-antibody survey to date, of nearly 8,000 blood test results, suggesting that 8.5 percent of the population already has Covid-19.
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