Direct-to-consumer fertility tests may provide users with access to information about their reproductive health without visiting a doctor, but new research has raised concerns about their safety and accuracy.
In two linked analyses, researchers at the University of Birmingham examined 30 diagnostic self-tests sold over the counter, including those for male fertility and menopause. Published in the BMJ this month, the first paper covered a review of the information provided on the tests to users. The second reported on the results of the researchers' investigation into claims about test accuracy. The researchers found that 60 percent posed high usability risks, and many lacked essential information about who should use them, how to interpret results, or what actions to take next.
'Self-tests have a clear potential to improve public health,' said Professor Jon Deeks, corresponding author of both papers, who led the research. 'But for them to be beneficial and not harmful, they must be proven to be accurate, easy to use, and supported by clear instructions.'
Only one of the three male fertility tests recommended use after one year of trying to conceive, consistent with UK guidance. The other two offered little context, making it unclear whether the tests were intended for screening, diagnosis, or general reassurance. Furthermore, male fertility tests typically measure sperm concentration or motility but neglect other clinically relevant factors like sperm morphology.
'More than half of couples with fertility problems are thought to have a male factor, but many men would not be abnormal by evidence of one of these tests,' Professor Jackson Kirkman-Brown, director of the Centre for Human Reproductive Science at the University of Birmingham, told the BMJ. 'There is no support or understanding of what they are looking at.'
The authors also reported that menopause self-tests, which detect levels of follicle-stimulating hormone (FSH) to determine fertility status, were among the four tests with most identified problems. UK guidelines do not recommend FSH testing to diagnose menopause in women over 45, yet some tests provided no indication of age-appropriate use. Other kits included instructions unsuitable for home use, such as freezing urine samples or using a centrifuge.
'There are significant risks to patients when poor quality tests are carried out inappropriately, with both false reassurance and unnecessary consequences for the NHS to repeat tests or take additional action,' Dr Bernie Croal, president of the Royal College of Pathologists told the BMJ.
While well-established self-tests like pregnancy tests are endorsed by the NHS, experts argue that newer tests often lack the regulatory oversight or clinical evidence required for safe use. However, as the at-home testing market grows – expected to reach revenue of £660 million by 2030 – some experts have called for urgent regulatory reform to protect users.
For example, in an BMJ editorial accompanying the papers, GPs and academic researchers, Dr Jessica Watson and Dr Margaret McCartney, concluded: 'Empowering individuals to take an active role in their health is an important goal, but if self-tests are to be sold directly to the public, they must be supported by high quality evidence, robust regulation, trustworthy public information, and clear pathways for interpretation and follow up.'
The Medicines and Healthcare products Regulatory Agency has said it is reviewing the evidence.
