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GUIDE-DTCTs

Guidance for the Regulation, Evaluation, Marketing and Monitoring of DTCTs.

Direct To Consumer Tests (DTCTs) have the potential for significant positive impacts on individuals, populations and the health economy through increasing autonomy, acceptability and expediating diagnoses. However, DTCTs also have considerable potential to cause harm.

In the absence of UK guidance or regulation DTCTs may exploit the worried well, deviate from evidence-based testing guidance and worsen existing NHS capacity issues as consumers seek support with test interpretation from healthcare professionals.

Great Britain (GB) is in a period of transition from EU regulations towards the development of GB specific medical devices regulation. This creates an opportunity to develop new regulation and policy to avoid the potential harm and financial burden to the public and NHS of the current DTCT landscape.

GUIDE-DTCTs is an 18-month project funded by Cancer Research UK (CRUK). The project will convene a multidisciplinary stakeholder group representing the medical and pharmaceutical professions, regulatory bodies, manufacturers, retailers, policy makers and the public. The stakeholder group will oversee a programme of research to develop evidence requirements for risk classification of DTCTs, standards for labelling, including reporting of tests claims, instructions for use at the point of sale and interpretation of test results. Proposed evidence requirements and standards will feed into the development of new regulation policies.

Better regulation for self-test health kits | University of Birmingham

Transcript

During the pandemic, we all got used to using lateral flow tests. Since then, a wider range of diagnostic and screening tests have become available for us to buy in supermarkets and pharmacies. But how useful are those tests?

I'm Clare Davenport. I'm an Associate Clinical Professor at the University of Birmingham and a Consultant in Public Health. I work in a research team that specialises in looking at the harms and benefits of medical tests. These new diagnostic and screening tests cover conditions such as vitamin deficiency, testing for the menopause and cancer. They've all been approved for sale and carry a regulator CE mark. But what consumers may not be aware of is that they haven't gone through the same stringent regulation and evaluation as pharmaceuticals.

What our research has done is questioned the usability, safety and accuracy of these new tests. These are tests that require a blood finger prick sample or mouth swab. Results are available quickly to be seen by consumers. Don't have to be sent off to a laboratory.

Whilst these tests may be attractive because they're convenient and they offer privacy, we have concerns about how suitable and safe they are for use without the health professionals input. For example, in some of the tests that we looked at, the instructions for use for very difficult to follow. Sometimes it was not possible to tell what a positive or negative test result was. And for a lot of the tests where we were required to take a finger-prick blood sample, we were not able to do this.

Consumers should be cautious when using these tests. Our research demonstrates the need for more stringent regulation and clearer standards to ensure the safety and effectiveness of tests bought over the counter. 

Publications

Direct-to-consumer self-tests sold in the UK in 2023: cross sectional review of regulation and evidence of performance, The BMJ, 2025 (B. Hillier)

Direct-to-consumer self-tests sold in the UK in 2023: cross sectional review of information on intended use, instructions for use, and post-test decision making, The BMJ, 2025 (C. Davenport)

 

Contact us

For more information about the project and other queries please email dtct@contacts.bham.ac.uk.

Alternatively, please register your interest directly on our online expression of interest form.

  • Funding

    GUIDE-DTCTs is funded by Cancer Research UK.