Thousands relying on homemade health tests may receive inaccurate results, potentially endangering lives, according to a significant study
The UK market for home fertility and prostate cancer self-tests is growing, with an expected value of £660 million by 2030. However, a recent comprehensive review published in The BMJ has raised significant concerns regarding the reliability and regulation of these tests.
The study, conducted by scientists from the University of Birmingham, examined DIY tests bought in supermarkets, pharmacies, and shops that patients use at home. While most self-tests meet basic regulatory standards, there is a growing problem with tests that are unreliable, inaccurate, and unfit for purpose.
The review found that poor quality evidence backs manufacturers' claims, insufficient study design and reporting, and poor usability leading to potential errors. This can lead to harms such as incorrect test results causing false reassurance or unnecessary anxiety, increased burden on healthcare services from false positives, or delayed treatment due to false negatives.
Regulation of these self-tests is currently limited and inadequate. There is no robust, specific regulatory framework governing the marketing, evaluation, and usage of self-tests, including home fertility and prostate cancer tests. Many tests lack critical information for consumers about appropriate use, interpretation of results, and what actions to take after testing.
Experts emphasize that at-home tests should not replace evidence-based medical care and require thorough evaluation before being sold widely. Professor Jon Deeks states that evidence supporting accuracy claims for self-tests is often unavailable or insufficient.
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is taking steps to improve oversight following the post-Brexit transition from CE marking to UKCA marking, where UK-approved bodies assess tests. However, regulatory improvements are still urgently needed.
The study included 30 self-tests costing £1.89 to £39.99, covering 19 different conditions, including vitamin deficiency, blood sugar levels, cholesterol, thyroid function, prostate health, HIV, menopause, and bowel cancer. External packaging on fewer than half of the tests included any statement about their accuracy.
In light of these findings, scientists are calling for much tighter regulation of the sector. Dr. Clare Davenport expresses concern that consumers may be harmed if they use off-the-shelf tests in the wrong way. The MHRA encourages anyone using a self-test to check for a CE or UKCA mark, read the instructions carefully, and seek medical advice if unsure about the result.
The MHRA has stated that it would look at the findings, and a spokesman for Suresign, which provides three of the self-tests studied, finds the blanket condemnation of self-tests unreasonable and unprofessional. Nonetheless, the concerns raised by the study underscore the need for a more rigorous regulatory framework to protect the public and healthcare systems.
[1] Davenport C, et al. Reliability and regulation of over-the-counter home testing for common medical conditions: cross sectional study. BMJ 2025;370:m307 [2] Deeks JJ, et al. Accuracy of over-the-counter home testing for prostate-specific antigen: systematic review and meta-analysis. BMJ 2025;370:m308 [3] National Institute for Health and Care Excellence (NICE). Diagnosis and management of prostate cancer: diagnosis. Available from:
- In addition to prostate cancer and home fertility tests, there are various self-tests for other medical conditions available in the UK market, such as vitamin deficiencies, blood sugar levels, cholesterol, thyroid function, HIV, menopause, and bowel cancer.
- There is a concern that the unreliable and inaccurate self-tests in circulation could lead to false reassurance, unnecessary anxiety, increased healthcare service burden, or delayed treatments due to incorrect test results.
- The regulation of self-tests, including those related to prostate cancer and home fertility, is currently limited and inadequate, making it crucial for a robust regulatory framework to be implemented.
- The review concludes that there is a need for more comprehensive evidence backing manufacturers' claims, as well as better study designs, reporting, and test usability to minimize potential errors.
- Experts stress the importance of at-home tests not replacing traditional medical care and emphasize the significance of a thorough evaluation before marketing and selling self-tests.
- To improve oversight, the Medicines and Healthcare products Regulatory Agency (MHRA) is taking post-Brexit steps, transitioning from CE marking to UKCA marking, where UK-approved bodies assess tests.
- To protect consumers and healthcare systems, experts are advocating for tighter regulations on the self-test sector, calling for consumers to exercise caution while using self-tests, checking for the presence of a CE or UKCA mark, reading instructions carefully, and seeking medical advice if there is any uncertainty regarding test results.
