Davenport Clare, Richter Alex, Hillier Bethany, Scandrett Katie, Agarwal Ridhi, Baldwin Simon W, Kale Aditya U, Alderman Joseph, Macdonald Trystan, Deeks Jonathan J
Department of Applied Health Sciences, School of Health Sciences, College of Medicine and Health, University of Birmingham, Birmingham, UK.
NIHR Birmingham Biomedical Research Centre, Birmingham, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, Birmingham, UK.
BMJ. 2025 Jul 23;390:e085546. doi: 10.1136/bmj-2025-085546.
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.
Cross sectional review of information on self-test boxes and instructions for use leaflets.
Supermarkets, pharmacies, and health and wellbeing shops within a 10 mile radius of the University of Birmingham's campus at Edgbaston in 2023.
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.
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.
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.
回顾英国商业街店铺所售自测设备提供的信息，并评估基于使用、解读及检测后行动，这些信息对做出明智决策的适用性。
对自测盒及使用说明书上的信息进行横断面回顾。
2023年位于埃奇巴斯顿的伯明翰大学校园半径10英里范围内的超市、药店以及健康与养生商店。
关于检测预期用途、生物标志物及临床状况的信息、检测结果的解读、检测后行动的建议，以及预期用途和检测后建议与循证指南的一致性。
纳入了针对19种不同状况评估20种生物标志物的30项自测。少数盒子上有指导购买的信息：谁应该使用该检测以及何时使用（8/30，27%）、检测结果后的行动（7/30，23%）以及检测数值表现（10/30，33%）。从盒子上或使用说明书中提供的信息来看，21项（70%）自测被判定用于诊断，15项（50%）用于筛查，不过3/21（14%）未提供任何有关症状的信息，10/15（67%）未提供任何有关风险因素的信息以指导使用。如果结果呈阳性或异常，27项（90%）自测建议寻求医疗专业人员的后续跟进；如果检测结果为阴性或正常，14项（47%）有此建议。19种状况中有11种（58%）的检测使用在目标人群、检测频率、检测阈值或某种状况所需的调查方法中的一项或多项方面被判定与循证指南相悖。
当前自测市场无法支持消费者就其使用、检测结果解读及后续行动做出明智决策。在自测下游工作的临床医生在将检测结果纳入实践时可能会面临重大挑战。随着自测使用的持续增加，迫切需要加强监管监督，以保护公众和医疗系统不被滥用。
