Tighter regulation needed for self-tests

Studies suggest that some commercially available health tests are inaccurate and unsuitable for public use, according to an analysis in The BMJ, and risk increasing workload for GPs and their teams.

Self-testing kits – including for male fertility, vitamin D deficiency, menopause and even cancer – are readily available in supermarkets and offer to provide consumers with simple, instantaneous answers to complex problems.

Availability of self-testing kits has expanded rapidly since the introduction of lateral flow tests during the COVID-19 pandemic, and the UK market for self-tests is expected to be worth £660m by 2030. But studies have raised serious concerns about their accuracy, clinical value, and regulation.

New evidence of risks

Researchers at the University of Birmingham assessed 30 tests for 19 different health conditions, bought locally in 2023, and found that 60% had at least one high risk usability problem. Despite claims of accuracy, supporting evidence was often unavailable or flawed, based largely on poorly designed laboratory studies. Study reports for only 12 of the 30 tests could be obtained, and many lacked robust data.

The tests, which have CE marks – a certification mark to signify that products have met essential European standards – are sold in major retailers such as Tesco and Superdrug and retail at £1.89 to £39.99. They require samples from a range of body fluids, including nasal and oropharyngeal secretions, capillary blood, urine, seminal fluid, vaginal secretions, and stool.

Many of the kits assessed had poorly written instructions that failed to clearly explain how to collect samples and interpret results, researchers found. Some had instructions clearly not suitable for home use, such as suggesting a centrifuge to clear a cloudy urine sample. Key information about test limitations was omitted, as were details about follow-up actions and when to seek medical advice. Packaging often featured bold diagnostic claims without adequate context or supporting detail.

Of the 30 tests, only eight provided information on the box about who should or should not use the test to guide purchasing decisions, only seven indicated the action that would follow the result, and only 10 provided quantitative information about the accuracy of the test.

Jon Deeks, professor of biostatistics at the University of Birmingham and corresponding author of the studies, says: ‘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.’

Nearly all tests recommended follow-up with a healthcare professional – and not only when results were positive. Fourteen of the 30 tests recommended seeking support if results were negative.

Professor Kamila Hawthorne, chair of the Royal College of General Practitioners, which has campaigned for greater transparency around these kits, says that there are ethical concerns about making money out of people without the necessary health literacy. ‘With the risk of false positives and negatives, and no offer of an interpretation of the results or aftercare, self-testing kits can mean patients experience a significant amount of stress and anxiety, prompting them to seek guidance from their GP to interpret any results. This not only negatively impacts patients, but it can also intensify the enormous pressures that GPs and their teams are currently under,’ Professor Hawthorne said. ‘Commercial self-testing kits should not default to NHS general practice as the provider for next steps and aftercare, unless the test was initiated in primary care or as part of a commissioned NHS service.’

Coombes R, et al. How safe are health tests on UK supermarket shelves? BMJ 2025;390:r1503. https://www.bmj.com/content/390/bmj.r1503