Many home diagnostic kits sold in supermarkets and pharmacies are unfit for purpose and could provide misleading results, according to new research. Scientists at the University of Birmingham reviewed 30 tests covering 19 conditions, including high cholesterol, vitamin deficiency, fertility, prostate health, HIV and bowel cancer.
The two linked studies, published in the British Medical Journal (BMJ), rated 60% of the tests as “high risk” because of concerns about equipment, sampling processes or instructions. Only eight stated who the tests were suitable for, and fewer than half provided any information about accuracy; much of the evidence for those claims was not publicly available or was of low quality.
Dr Clare Davenport, an associate clinical professor at the University of Birmingham and co-lead author, questioned the value of tests that advise users to consult their GP regardless of the result: “This begs the question: ‘What’s the point of doing the test in the first place?’” She added that the tests are not endorsed by the NHS and that evidence for their benefit is lacking, unlike well-established self-tests such as pregnancy kits.
The studies call for tighter regulation by the Medicines and Healthcare products Regulatory Agency (MHRA). Professor Jon Deeks, co-lead author, said self-tests have potential to improve public health but must be proven accurate, easy to use and supported by clear instructions. Joseph Burt of the MHRA said the agency would review the evidence and has strengthened post-market surveillance powers, while overhauling medical device regulations to improve safety and transparency.
Professor Kamila Hawthorne, chair of the Royal College of GPs, warned that false results cause stress and anxiety, prompting patients to seek GP help. She said these tests should not default to NHS general practice for aftercare unless initiated by a GP or commissioned NHS service.
