High street self-tests for bowel cancer and menopause may be unfit for purpose, researchers warn

Independent

a day ago

High street self-tests for vitamin deficiencies, menopause and bowel cancer may not be fit for purpose, researchers have warned.
There are many products available to UK customers without the need for a doctor's appointment. But concerns have been raised about the quality, appropriateness and safety of these kits, with doctors warning they could be 'dangerous' and cause 'false reassurance'.
The researchers called for much tighter regulation of the sector, warning the NHS may face additional demand after people self-test.
The market for self-tests is booming and is expected to reach a projected revenue of £660m by 2030 in the UK.
To put these readily available health checks to the test, researchers at the University of Birmingham reviewed 30 self-tests bought from local supermarkets, pharmacies and health and wellbeing shops.
The findings published in the BMJ on Wednesday show that most self-tests lack essential information about who should use them, how to interpret the results, and what actions to take next.
Researchers looked at tests that covered 19 conditions including vitamin D deficiency, blood sugar, thyroid function, prostate health, HIV, menopause and bowel cancer.
However, out of the 30 tests, less than half made any statement about accuracy, and only eight had information on the box about who should or should not use the test. Just seven of the at-home tests told users what to do after getting their results.
Just 16 tests explicitly stated they were for screening, diagnosis, or monitoring, while nine did not indicate the symptoms or risk factors for their use. However, nearly all tests (27 out of 30) recommended follow-up with a healthcare professional if results were positive or abnormal, and 14 regardless of the result.
Around half (14) claimed an accuracy of 98 per cent, but study authors highlighted that the evidence to back these claims was either not publicly available or was of low quality, which they said raised ethical concerns.
Researchers also said 18 of the tests were 'high risk' due to the quality of the testing equipment, sampling process, or instructions and interpretation of the results.
The authors acknowledge that the study sample was restricted to the Birmingham area and that their assessments were limited by the lack of access and poor reporting of documentation provided by manufacturers. However, they say this is a robust, reliable evaluation of self-tests available to the UK public.
Kristien Boelaert, professor of endocrinology at the University of Birmingham and a consultant endocrinologist, said: 'I actually think it's dangerous. I would like there to be central UK-wide regulation... that prevents these things from coming on the market. I think the biggest potential harm is a false reassurance that, if it's not positive, everything is fine.'
Joseph Burt, head of diagnostics and general medical devices at the Medicines and Healthcare products Regulatory Agency (MHRA), said it would review the evidence and 'consider all allegations about device deficiencies'.
He added: 'We have strengthened post-market surveillance powers to monitor and act on concerns. These require manufacturers to actively monitor their products and report significant incidents to us, including for CE-marked self-tests.
'We're overhauling the medical device regulations to further strengthen standards for safety, usability and clinical performance, and we're exploring new transparency measures such as requiring published summaries of clinical evidence.
'In the meantime, we strongly encourage anyone using a self-test to check for a CE or UKCA mark, read the instructions carefully, and seek medical advice if they're unsure about their result.'
Bernie Croal, president of the Royal College of Pathologists, warned of the knock-on effects for the NHS: 'There are significant risks to patients when poor quality tests are carried out inappropriately, with both false reassurance and unnecessary consequences for the NHS to repeat tests or take additional action.'
Since the initial sample in 2023, researchers have continued to track the booming self-test market. A repeat search of the same geographical area in December 2024 identified 63 tests, twice as many as the previous year.
'There is an urgent need for coherent guidance and improved regulation to protect both individuals and healthcare systems from misuse and misinformation,' researchers concluded.
Irwin Armstrong, founder and CEO of CIGA Healthcare and Suresign, which provides three of the numerous self-tests studied, criticised the BMJ study.
He 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 [that] our tests give the public access to healthcare screening not easily available with the NHS at the present time.'
Mr Armstrong added: 'Suresign tests are intended to be used as screening tests and not for taking medical decisions. They are not intended to replace tests carried out by professionals. Currently, it is difficult to get an appointment with a GP and therefore, these tests provide information to enable users to actively seek a medical opinion if necessary.'