Concerns Mount Over Accuracy of At-Home Health Tests as Study Calls for Stricter Regulation

Published: 24 July ‘2025. The English Chronicle Online.

As the popularity of at-home health tests continues to rise among UK consumers seeking privacy, convenience, and swift results, new research has raised serious concerns over their reliability, safety, and the regulatory framework governing them. Two comprehensive studies, published in the British Medical Journal (BMJ), warn that many of these widely available self-diagnostic kits offer incomplete or misleading information, and in some cases, may pose significant risks to public health.

Researchers from the University of Birmingham analysed 30 over-the-counter health kits, ranging in price from £1.89 to £39.99, during 2023. These kits are designed to detect a variety of health conditions, including bowel cancer, vitamin deficiencies, thyroid disorders, HIV, and menopause-related changes. While the appeal of direct-to-consumer tests has grown steadily—especially following the normalisation of home-based Covid-19 testing—the study revealed alarming gaps in the quality and transparency of many products currently on the market.

One of the study’s most critical findings was the lack of essential guidance for users. Fewer than half of the test kits reviewed provided any indication of their accuracy, and only a quarter offered clear instructions on interpreting results or next steps following a positive or negative outcome. Strikingly, nearly 50% of the tests advised users to consult a healthcare professional regardless of the result—a recommendation that could inadvertently increase strain on NHS services already under pressure.

Professor Jon Deeks, who led the Birmingham study, stressed that while self-tests have the potential to revolutionise personal healthcare and reach underserved communities, they must be held to a high standard. “Self-tests have a clear potential to improve public health,” he said. “However, for them to be beneficial and not harmful, they must be proven to be accurate, easy to use, and supported by clear instructions.”

The British self-test market is booming, with forecasts suggesting it will reach revenues of £660 million by 2030. However, with this growth comes a heightened responsibility to ensure consumers are not misled. The BMJ article notes that many self-testing kits are currently marketed based on what people are willing or able to pay rather than clinical necessity, which risks deepening health inequalities and exploiting vulnerable populations.

While some test kits claim accuracy rates of over 98%, the researchers found that manufacturers rarely made the supporting clinical data publicly available. At present, companies are not legally obliged to publish performance evidence, though both the BMJ and the Royal College of General Practitioners are urging for greater openness and transparency in the industry.

Bernie Croal, President of the Royal College of Pathologists, echoed these concerns, warning that poor-quality testing can lead to “false reassurance” or “unnecessary consequences” for both individuals and public health services.

In response to the findings, the UK’s medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), confirmed it is reviewing the research and planning to overhaul safety standards for self-tests. Joseph Burt, Head of Diagnostics and General Medical Devices at MHRA, said the agency is considering new transparency measures, including requiring manufacturers to publish summaries of clinical evidence. He also urged the public to check for CE or UKCA markings when purchasing test kits and to consult medical professionals when in doubt.

Despite not being included in the Birmingham study, pregnancy tests and Covid-19 lateral flow kits—both long-established staples of self-testing—illustrate how home diagnostics can be successfully integrated into mainstream healthcare. However, the studies suggest that the newer wave of at-home kits, particularly those addressing more complex medical issues, require far more rigorous oversight.

Ultimately, while self-tests may offer autonomy, speed, and privacy, the findings make it clear that these benefits must not come at the expense of public safety. The urgent call from researchers and clinicians alike is for a regulatory environment that ensures every self-test on the shelf is not only accessible, but also accurate, transparent, and clinically sound.