Home-based fertility and menopause blood tests unreliable

Unreliable direct-to-consumer fertility tests reporting hormone levels, were sold and processed in the UK for nearly 18 months after problems were initially identified.

An investigation by the BMJ has found that a private laboratory continued to process oestradiol tests for months after deeming them unreliable. These tests were sold to customers as an indicator of fertility levels in women. The story has raised wider concerns over the regulation of at-home medical tests sold direct to consumers.

Dr Bernie Croal, president of the Association for Clinical Biochemistry and Laboratory Medicine and Royal College of Pathologists, commented: 'Providers of testing need to be regulated or inspected to ensure what they are doing is valid and backed up by quality systems. Poor quality, unregulated laboratory services pose a significant risk to patients'.

Eurofins County Pathology laboratory, Guildford, continued to process blood samples for the female sex hormone oestradiol after finding the test inaccurate. Oestradiol, also known as E2, is a form of oestrogen that is commonly evaluated in relation to fertility and menopause.

Internal investigations by Eurofins showed that the home finger prick tests, which sample blood from capillary vessels, showed a 'negative bias' – the level of oestradiol detected in capillary blood samples was consistently lower compared with blood from veins, which is how blood would be sampled by a healthcare professional. This was compounded by the type of collection tube provided with the test. The findings were only reported to the online retailers selling the tests nearly a year later, in October 2022, and Eurofins continued to process returned tests until at least July 2023. Two other private laboratories which conduct the same test, and one retailer, ceased providing the tests as soon as concerns were raised.

Members of the medical community have expressed concern for patients over the lack of regulation for at-home fertility and menopause tests.

Dr Jessica Watson, a GP in Bristol who researches the use of clinical tests in primary care, commented: 'There is a risk that results might be misinterpreted or be misleading – and that could have implications for women if they believe that they are more or less fertile, for example, even if that just steers their decision making a little bit.'

She added: 'The whole field of home testing kits is progressing rapidly but it doesn't feel as if the frameworks for legislation are able to keep up.'

The investigation by the BMJ comes after a recent qualitative study published in JAMA Network, which showed three quarters of websites selling fertility hormone tests made misleading and inaccurate scientific claims (see BioNews 1204).