Medical professionals have strongly criticised the government’s proposed rollout of finger prick coronavirus tests to the public, saying that such screening must be supervised by healthcare specialists.
Doctors and industry trade bodies warned that Covid-19 antibody tests, which screen for whether someone has recovered from the disease, were not appropriate for use by the public.
The government has touted the rollout of finger prick antibody tests, which could potentially give results to people at home based on blood samples within 15 minutes, as a key part of its efforts to tackle coronavirus and end the nationwide lockdown.
Last month, Public Health England, the agency responsible for dealing with public health emergencies, said the government had ordered 3.5m of these tests and that they could be available within weeks for sale to the public through retailers such as Amazon and Boots.
However, while several Covid-19 antibody tests are being trialled by researchers at Oxford university, none has been formally endorsed by PHE for use by hospital doctors and general practitioners.
Additional regulatory approval would then be required if the tests were to be sold for use by the public.
The Medicines and Healthcare products Regulatory Agency, the UK medicines regulator, said it knew of no antibody tests that were approved for public use.
PHE statements about the prospect of at-home antibody tests are “hyperbolic and inaccurate”, said Eoghan Macsweeney, co-founder of CityDoc, a network of private GP practices.
“Healthcare professionals will have to supervise interpretation of these results,” he added. “It’s not a simple process, it’s easy to do the test wrong.”
Doris-Ann Williams, chief executive of the British In Vitro Diagnostic Association, a trade body, said the fast rollout of at-home antibody tests was “really unlikely and BIVDA believe it would be unwise”.
Screening should be done by healthcare professionals “and not by individuals for themselves and their families”, she added.
There are broad concerns about the accuracy of antibody tests for coronavirus.
The Institute of Biomedical Science, the professional body for biomedical scientists in the UK, on Friday said there were “huge issues surrounding the reliability of point of care antibody tests”.
One in 10 people who test positive “will be ‘false positives’ and will not have immunity”, added the IBS.
Matt Hancock, health secretary, on Thursday last week said the government was working with nine companies to get an effective antibody test approved. He admitted that several tests had failed to produce accurate results.
Scientists have stressed that antibody tests will be most useful for gauging whether the population has acquired resistance to coronavirus.
It is “the key thing we need”, said Robin May, professor of infectious diseases at Birmingham university.
But to do this, widespread testing and data collection will be necessary. If tests were done by individuals at home, it is not clear how people would report their results.
“PHE is not providing any guidance [about how reporting would work],” said Brigette Bard, chief executive of BioSure, which developed the first HIV at-home tests to use blood that were approved by regulators.
In HIV antibody tests, it is standard practice for people whose results are positive to do second, confirmatory ones. Whether this will be required for Covid-19 antibody tests is unclear.
PHE directed questions by the Financial Times to the Department of Health and Social Care for Health, which declined to comment.
Some scientists have warned that selling antibody tests to the public is likely to be a poor use of scarce resources, and suggested that the initial focus should be on National Health Service staff.
“One can only begin to imagine the dramas that will unfold from putting a small amount of kits, relative to the population, into the hands of the public,” said Saul Khan, executive director of Rapidward, an Australian non-profit organisation selling Covid-19 antibody tests.
“Now is not the time for half measures. Now is the time to do things the right way.”
