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
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%
