Off-the-shelf health tests for issues such as high cholesterol, vitamin deficiency, fertility and prostate problems may not be fit for purpose, new research has found.
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.
The researchers called for much tighter regulation of the sector, adding the NHS may face additional demand after people self-test.
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.
“Test errors can stem from inherent limitations in the accuracy of the test, as well as user-related issues such as sampling errors, incorrect processing, and difficulties in interpreting the results.”
However, the team said that in the future, home tests could have great potential for patient care.
The Medicines and Healthcare products Regulatory Agency (MHRA), which regulates medical products, said it would assess the findings.
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.
“Our recent research raises concerns about the suitability, accuracy and usability of many of the self-testing products available that require users to sample, test and interpret results themselves. In some cases, it is unclear how accuracy claims are supported, and there is no requirement of manufacturers to share the evidence behind these claims.”
‘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.
He said much of the literature contained with tests was “not easy to understand”, while some of the results could lead to a “wrong diagnosis”.
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)Self-testing is becoming increasingly popular, and the UK market for self-tests is expected to reach £660m by 2030. Overall, 30 self-tests costing £1.89 to £39.99 were included in the study, published in the BMJ.
The tests covered 19 different conditions, including vitamin deficiency, blood sugar levels, cholesterol, thyroid function, prostate health, HIV, menopause and bowel cancer.
Researchers said only eight of the 30 tests provided information about who should or should not use the test, while four specified the presence of symptoms. External packaging on fewer than half of the tests (14) included any statement about their accuracy.
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.
Accuracy claims were made for 24 of the tests, including in pamphlets, and most (58 per cent) claimed a performance of at least 98 per cent accuracy, sensitivity or specificity.
However, the researchers said evidence supporting accuracy claims were largely unavailable or did not provide sufficient information for people likely to purchase the tests.
Professor Deeks said: “Current regulations for the use of self-testing kits in a commercial setting are not adequately protecting consumers.”
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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.
“I’m certainly not saying that tests like this should be banned, or even radically discouraged. The authors of these research papers aren’t saying that either… These studies make it clear that users of many self-tests aren’t given easy access to relevant information, and that the regulation isn’t appropriate at present.”
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.
“This is not a clinical approach to a highly scientific subject. They also did not confirm that the clinical studies related to our tests were supplied to them, as confirmed to us by the BMJ.
“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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