NAIROBI, Kenya – Home health test kits sold across UK supermarkets and high streets may be giving consumers misleading or inaccurate results due to poor regulation and lack of vital information, two new studies published in the British Medical Journal (BMJ) have revealed.
Researchers from the University of Birmingham analysed 30 self-testing kits commonly used to screen for conditions such as bowel cancer, thyroid dysfunction, HIV, vitamin deficiencies, and menopause.
They found that the majority lacked clear guidance on how to interpret results or what steps users should take next — raising major public health concerns.
Of the kits examined — which cost between £1.89 and £39.99 — fewer than half provided any details on accuracy, and only one in four included advice on what to do after obtaining a result.
Alarmingly, nearly half of the tests advised users to consult a healthcare professional regardless of the outcome, potentially adding further strain to NHS services.
“High Risk” Products with Limited Oversight
The researchers categorised 60% of the kits as “high risk” due to concerns over safety, misleading claims, and insufficient clinical guidance.
“Self-tests have a clear potential to improve public health,” said lead researcher Prof Jon Deeks. “But for them to be beneficial and not harmful, they must be proven to be accurate, easy to use, and supported by clear instructions.”
While some kits boasted accuracy claims of more than 98%, the BMJ says that many of these figures were not backed by publicly available evidence. Currently, UK manufacturers are not legally required to publish clinical performance data.
The report adds that the growing availability of direct-to-consumer diagnostic tests based on ability to pay — not clinical need — could exacerbate health inequalities and exploit vulnerable groups.
Regulator Responds to Growing Market
The UK self-testing market is projected to grow rapidly, with revenues expected to hit £660 million by 2030.
In response to the research, the UK’s medical device regulator — the Medicines and Healthcare products Regulatory Agency (MHRA) — has pledged to strengthen oversight and improve transparency.
“We’re exploring new transparency measures, such as requiring published summaries of clinical evidence,” said Joseph Burt, head of diagnostics and general medical devices at MHRA. “We strongly encourage anyone using a self-test to check for a CE or UKCA mark, read instructions carefully, and seek medical advice if unsure about results.”
The Royal College of Pathologists also weighed in, warning that poor-quality tests could lead to false reassurance or trigger unnecessary and costly NHS interventions.
While self-tests like pregnancy kits and COVID-19 lateral flow tests — both widely trusted — were not included in the Birmingham study, experts argue that the newer, less regulated offerings now flooding the market must meet the same standards of safety and effectiveness.
