IBMS responds to BMJ DIY test kits studies

The IBMS welcomes the publication of new research in the British Medical Journal (BMJ), which evaluated a wide range of over‑the‑counter self‑testing kits for conditions including vitamin deficiencies, hormonal imbalances and prostate health. The findings raise urgent concerns about the safety, reliability and regulation of these tests.

Unsubstantiated claims and weak evidence base

The BMJ study found that many commercially available kits make bold claims about their accuracy, often without sufficient clinical validation. In over half of the tests reviewed, there was no published data to support the reliability of results. This lack of transparency puts public trust at risk.

High risk of misleading results

A significant number of the tests were categorised as high risk due to issues with sampling procedures, unclear instructions, or inadequately explained results. These limitations increase the likelihood of misinterpretation, leading to unnecessary anxiety or inappropriate action by the user.

Impact on public health and NHS services

The studies also raised concerns about the burden these tests may place on health services. Users are often advised to contact their GP regardless of the result, potentially creating additional pressure on already stretched primary care services. The BBC’s recent reporting on DIY test kits further highlighted these risks and the need for greater regulation.

A Consistent Call for Caution

In response to the increasing availability of at-home PSA tests, the IBMS has previously raised these concerns - 'At home PSA tests' statement on 5 March 2025. At the time, we stressed that while direct-to-consumer testing may offer benefits such as increasing awareness or prompting earlier healthcare engagement, it must not compromise clinical effectiveness or patient safety.

Those warnings are now echoed in the BMJ’s findings and further validate our position: unregulated private testing can lead to confusion, false reassurance, and unnecessary strain on NHS services.

IBMS recommendations

Stronger regulation and higher quality standards

• Regulatory bodies such as the MHRA must enforce stricter oversight of at-home test manufacturers to ensure products are clinically valid, accurate and safe.

• There should be clearer restrictions on how tests are marketed—particularly in relation to cancer risk and diagnostic capability.

Public education and clinical guidance

• Public understanding of the differences between NHS laboratory testing and consumer kits must be improved.

• Men concerned about prostate cancer, for instance, should be encouraged to consult a GP, rather than rely on private PSA tests.

• Healthcare professionals should be supported in managing the downstream consequences of misleading or inconclusive test results.

Integrated testing pathways

• Where private testing is available, results must be safely integrated into NHS care to avoid duplication and ensure appropriate follow-up.

• Collaboration between public health bodies, private providers and regulators is essential to develop clear pathways and protect patient safety.

David Wells, IBMS Chief Executive stated: 

The BMJ study adds weight to our previously stated concerns about the risks of unregulated at-home diagnostic testing. While wider access to testing can be a positive development, it must be underpinned by robust evidence, strong regulation and clear public guidance.

The IBMS renews its call for urgent action to ensure that home testing supports early diagnosis and better outcomes—without undermining public confidence, clinical standards or NHS capacity.