Direct-to-consumer self-tests sold in the UK in 2023: Cross sectional review of regulation and evidence of performance

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.