A team from the University of Birmingham examined tests that people can buy in UK supermarkets, pharmacies and shops, and which they then use at home. They found the tests risked giving people the wrong result, could delay diagnosis, and most of them recommended follow-up with a doctor anyway, regardless of the result.
They said: “In the absence of guidance from healthcare professionals, individuals might use tests inappropriately or without a clear understanding of the implications of the results. False positive test results can lead to unnecessary anxiety, increased healthcare usage, and additional costs, whereas false negative test results may delay appropriate treatment or engagement with… screening programmes.
However, the team said that in the future, home tests could have great potential for patient care.
Professor Jon Deeks, from Birmingham university, said: “A plethora of new health self-tests have emerged in recent years and are available to buy from many high street supermarkets and pharmacies in the UK. While these kits have been approved for sale, they are not subject to the same stringent regulations as pharmaceutical products.
‘New world’ of self-testing
Professor Deeks said the UK is looking at a “new world” when it comes to self-testing, but there is more work to do to show claims made were robust.
In one example, he said the self-tests for prostate-specific antigen (PSA) levels, a marker of prostate health, were fixed at a certain concentration level. However, “if you’re age 70 you need to have your PSA done at a very different level to when you’re 20”, he said.
The UK has seen an explosion of at-home testing in recent years (Photo: Getty)The tests covered 19 different conditions, including vitamin deficiency, blood sugar levels, cholesterol, thyroid function, prostate health, HIV, menopause and bowel cancer.
Meanwhile, 90 per cent of the tests recommended a follow-up with a healthcare professional if test results were positive or abnormal, while 47 per cent recommended this if test results was negative.
However, the researchers said evidence supporting accuracy claims were largely unavailable or did not provide sufficient information for people likely to purchase the tests.
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Read MoreKevin McConway, emeritus professor of applied statistics at The Open University who was not involved in the research, said: “I think the findings of these new studies on self-tests for health conditions, available [at a cost] in supermarkets, high street chemists and online, are scary and concerning.
A spokesman for Suresign, which provides three of the self-tests studied, said: “We find this blanket condemnation of a small range of home tests available to be unreasonable and unprofessional, since they admit they are content with many of those examined.
“Our detailed responses to their questions were not fully reflected in their article. They have implicitly criticised the professionalism of notified bodies appointed by the MHRA, when we find them to be very exacting in their audits. We are content our tests give the public access to healthcare screening not easily available with the NHS at the present time.”
Joseph Burt, MHRA head of diagnostics and general medical devices, said it would review the evidence and “consider all allegations about device deficiencies”.
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