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%). 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.