Shaping regulation, improving transparency and consumer protection for health self-tests

Our researchers worked to address growing concerns about the safety, accuracy and regulation of direct-to-consumer self-tests (DTCTs), which are increasingly sold in supermarkets, pharmacies and online. These tests cover conditions including vitamin deficiency, cholesterol, menopause and bowel cancer, and often claim >98% accuracy. However, unlike pharmaceuticals, self-tests undergo far less rigorous scrutiny before entering the market.

This matters because patients and the public use these tests without medical support, meaning inaccurate or misleading results could delay treatment, create unnecessary anxiety, or generate avoidable NHS investigations.  

30 self-tests were evaluated and found that 87% raised concerns, with approximately 70% considered high risk because the probability of error was high or the potential harm was severe. Problems included poor instructions, inaccessible/misleading information, flawed equipment, unclear result interpretation, and requirements for laboratory equipment or PPE unsuitable for home use. Some manufacturers were unwilling to share supporting evidence, raising ethical and regulatory concerns.

Patient and public contributors also highlighted the need for clearer advice and reassurance that reliable tests, such as pregnancy tests, remain valuable.  

The work has achieved significant policy and regulatory impact. Findings published in the BMJ informed discussions with the Medicines and Healthcare products Regulatory Agency (MHRA), which investigated whether some DTCTs breached existing medical devices legislation. The Patient Safety Commissioner also explored risks posed by then prevailing regulation.

Importantly, the findings contributed to amendments by MHRA to the Devices Law on “Misleading or Unsubstantiated Claims”, creating a mechanism to remove tests from the market where evidence for safety, performance or intended use is inadequate. 

This work is shaping regulation, improving transparency and consumer protection. It provides a blueprint for regulators, consumer organisations and manufacturers to identify misleading claims and improve standards for self-testing devices – benefiting patients, protecting the NHS and supporting safer innovation within the UK diagnostics sector.