2025-07-24 バーミンガム大学
<関連情報>
- https://www.birmingham.ac.uk/news/2025/strict-regulations-needed-to-address-off-the-shelf-health-test-concerns
- https://www.bmj.com/content/390/bmj-2025-085547
- https://www.bmj.com/content/390/bmj-2025-085546
2023年にイギリスで販売された消費者向け自己検査キット:規制と性能の証拠に関する横断的レビュー Direct-to-consumer self-tests sold in the UK in 2023: cross sectional review of regulation and evidence of performance
Bethany Hillier, medical statistician;Jonathan J Deeks, professor of biostatistics;Joseph Alderman, clinical research fellow;Aditya U Kale, clinical research fellow;Trystan Macdonald, clinical research fellow;Simon W Baldwin, medical statistician;Katie Scandrett, medical statistician;Ridhi Agarwal, medical statistician;Alex Richter, professor of immunology;Clare Davenport, associate clinical professor
The BMJ Published: 23 July 2025
DOI:https://doi.org/10.1136/bmj-2025-085547
Abstract
Objectives To review the evidence base, clinical performance claims, and usability and safety of self-tests available for sale on the UK high street.
Design Cross sectional review of self-tests—regulation, evidence of performance, usability, and safety.
Setting Tests were identified from supermarkets, pharmacies, and health and wellbeing shops within a 10 mile radius of the University of Birmingham Edgbaston Campus in 2023.
Main outcome measures Accuracy claims of self-tests, samples used to derive accuracy measures, and regulatory requirements were summarised. Ergonomics, usability and safety concerns about the equipment and instructions, including interpretability and readability, were evaluated. Details of clinical and lay person study reports (population, sample size, reference or comparator tests, test process) were summarised, and methods were assessed using the Quality Assessment of Diagnostic Studies 2 (QUADAS-2) tool.
Results Thirty five self-tests were identified (30 obtained), which used seven different sample types and tested for 20 different biomarkers. Accuracy claims were made in instructions for use documents for 24/30 tests: accuracy for 19, sensitivity for 17, and specificity for 16. Performance claims of ≥98% were made on accuracy for 53% (10/19) of tests, 41% (7/17) on sensitivity, and 63% (10/16) on specificity. Where reference standards were reported in instructions for use documents, 29% (5/17) evaluated the accuracy of self-tests against similar rapid tests. For usability or safety, 18/30 self-tests had at least one high risk concern, 11 because of equipment, 10 because of the sampling process, and 15 owing to instructions or interpretation. Nine sets of clinical and lay person study reports were obtained (covering 12 tests). Across documents (nine clinical study reports and six lay person study reports) and QUADAS-2 domains, 73% were rated as having unclear risk of bias owing to poor reporting, and 58% were rated as having high applicability concerns because of inappropriate study designs. Participant descriptions were particularly inadequate in clinical study reports. Even within lay person study reports, few demographics (up to four) were presented. Some populations were unrepresentative of the intended user, inappropriate reference standards and thresholds were used, and mentions of blinding were scarce.
Conclusions This investigation highlights the need for improved regulatory oversight and clearer standards to ensure the safety and reliability of self-tests available on the UK market. Concerns about their ergonomics and usability might lead to test errors. Manufacturers’ unwillingness to provide public access to study documents raises ethical concerns. Additionally, inadequate study design and reporting in available documentation hinders the ability to assess the evidence base supporting the use of self-tests. As the availability and use of self-tests continues to rise, improved regulatory oversight is urgently needed to protect the public from the effects of poor performing diagnostic self-tests.
2023年にイギリスで販売された消費者向け自己検査キット:意図した使用目的、使用方法、検査後の意思決定に関する情報の横断的レビュー 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
Clare Davenport, associate clinical professor;Alex Richter, professor of immunology;Bethany Hillier, medical statistician;Katie Scandrett, medical statistician;Ridhi Agarwal, medical statistician;Simon W Baldwin, medical statistician;Aditya U Kale, clinical research fellow;Joseph Alderman, clinical research fellow;Trystan Macdonald, clinical research fellow;Jonathan J Deeks, professor of biostatistics
The BMJ Published: 23 July 2025
DOI:https://doi.org/10.1136/bmj-2025-085546
Abstract
Objectives To 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.
Design Cross sectional review of information on self-test boxes and instructions for use leaflets.
Setting Supermarkets, pharmacies, and health and wellbeing shops within a 10 mile radius of the University of Birmingham’s campus at Edgbaston in 2023.
Main outcome measures Information 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.
Results 30 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.
Conclusions The 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.
