Adapted from https://www.bmj.com/content/bmj/390/bmj.r1503.full.pdf
On the shelves of supermarkets and pharmacies across the UK, self-testing kits now sit alongside everyday health products. These range from male fertility checks and menopause indicators to vitamin deficiency and even cancer-related tests. The promise is straightforward: simple answers in the comfort of one’s home. Yet experts caution that the reality is far more complex, with risks of misinterpretation and unintended consequences.
Professor Jackson Kirkman-Brown, director of the Centre for Human Reproductive Science at the University of Birmingham, highlights the ease with which these products can be accessed. “Why is it that a 15 year old can walk in and buy one of these tests? There is no support or understanding of what they are looking at.” His concern reflects the central issue: without professional guidance, the results can easily be misleading.
In the case of male fertility kits, the tests often measure sperm count or motility but fail to assess other critical aspects such as sperm morphology. Clinics, by contrast, carry out broader examinations and consider partner factors. “More than half of couples with fertility problems are thought to have a male factor, but many men would not be abnormal by evidence of one of these tests,” Kirkman-Brown explains. A “normal” result can create false reassurance, while an “abnormal” one may cause needless anxiety and unnecessary interventions.
The rapid expansion of this market has been striking. Spurred on by public familiarity with lateral flow devices during the covid-19 pandemic, the UK self-test industry is expected to grow to £660m by 2030. Yet recent studies in The BMJ have raised serious concerns about accuracy, clinical relevance, and the adequacy of regulation.
Researchers from the University of Birmingham assessed 30 tests for 19 different conditions, purchased locally in 2023. They discovered that 60% carried at least one high-risk usability issue. Despite bold claims, the evidence underpinning these tests was often unavailable, incomplete, or based on flawed studies. Reports were retrievable for only 12 of the 30 products, and even those lacked robust detail.
The products, carrying the CE mark to show compliance with European safety standards, are available at retailers including Tesco and Superdrug, with prices ranging from £1.89 to £39.99. They require samples from a variety of bodily fluids, including urine, blood, saliva, stool, and even seminal or vaginal secretions. Yet many instructions were confusing, incomplete, or impractical for home use. One test required a centrifuge to process a cloudy urine sample, while others gave unrealistic guidance on freezing specimens to −20°C. In another case, instructions printed directly on a faecal sample sling became illegible during use.
Professor Jon Deeks, professor of biostatistics at the University of Birmingham, led the research. He argues that the public deserves better transparency. “Our 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.”
Attempts to obtain detailed study reports from manufacturers were largely unsuccessful. Many companies either declined to release information, citing commercial confidentiality, or failed to respond. Legally, they are not obliged to share data, but as Deeks notes, this leaves consumers making health decisions in the absence of verifiable evidence.
Concerns extend beyond usability to broader health system implications. Professor 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,” he told The BMJ.
For some specialists, the risks are particularly acute. Professor Kristien Boelaert, professor of endocrinology at the University of Birmingham and a consultant endocrinologist, described thyroid self-tests as “dangerous”. She emphasised the risk of false reassurance and called for centralised regulation to prevent unsuitable products reaching the market.
Calls for regulatory reform are growing. Dr Clare Davenport, clinical associate professor at the University of Birmingham, believes there should be a tiered approach. “The same consideration given to pharmaceuticals should be given to self-testing where some, such as pregnancy tests, could be sold over the counter and others that carry greater risk of misuse are sold only with the support of a pharmacist.”
Unlike medicines, which must undergo rigorous clinical trials and regulatory approval, self-tests are currently subject to lighter checks by European “notified bodies”, which award CE marks. This means that multiple branded kits sold in the UK often originate from just a handful of manufacturers. Although they appear to represent a wide market, many are simply rebranded versions of the same products.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has confirmed that CE-marked tests will be recognised in Great Britain until 2030. New post-market surveillance rules, introduced this month, will require manufacturers to monitor the use of these products and report significant incidents. However, questions remain over whether these measures will provide sufficient protection for patients.
Self-testing kits undoubtedly offer convenience and accessibility. For some conditions, they may provide a useful first step towards seeking care. But the evidence presented by Birmingham researchers underscores a crucial point: without accurate information, clear guidance, and robust regulation, the risks may outweigh the benefits.
