ArticleBMJ (Clinical research ed.)2025
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.
Article in BMJ (Clinical research ed.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- Direct-to-consumer self-tests sold in the UK in 2023: cross sectional review of regulation and evidence of performance.BMJ (Clinical research ed.) · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo review the information provided for self-test devices sold in high street shops in the UK and to assess their suitability for informed decision making based on use, interpretation, and post-test actions.
designCross sectional review of information on self-test boxes and instructions for use leaflets.
settingSupermarkets, pharmacies, and health and wellbeing shops within a 10 mile radius of the University of Birmingham's campus at Edgbaston in 2023.
main outcome measuresInformation on intended use of test, biomarker and clinical condition, interpretation of test results, recommendations for post-test actions, and coherence of intended use and post-test recommendations with evidence based guidance.
results30 self-tests assessing 20 biomarkers for 19 different conditions were included. Information to guide purchase was present on a few boxes: who should use the test and when (8/30, 27%), action after the test result (7/30, 23%), and numerical test performance (10/30, 33%). From the information provided either on the box or within the instructions for use leaflets, 21 (70%) self-tests were judged to be used for diagnosis and 15 (50%) to be used for screening, although 3/21 (14%) did not provide any information about symptoms and 10/15 (67%) did not provide any information about risk factors to guide use. 27 (90%) self-tests recommended follow-up with a healthcare professional if results were positive or abnormal, and 14 (47%) if test results were negative or normal. Use of tests for 11 of 19 (58%) conditions was judged contrary to evidence based guidance in one or more of the intended population, frequency of testing, test threshold, or investigative approach required for a condition.
conclusionsThe current market for self-tests does not support consumer informed decisions about their use, interpretation of test results, and subsequent actions. Clinicians working downstream of self-tests are likely to face important challenges in incorporating the results in practice. As the use of self-tests continues to increase, improved regulatory oversight is urgently needed to protect the public and healthcare systems from misuse.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.