Hillier Bethany, Deeks Jonathan J, Alderman Joseph, Kale Aditya U, Macdonald Trystan, Baldwin Simon W, Scandrett Katie, Agarwal Ridhi, Richter Alex, Davenport Clare
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:e085547. doi: 10.1136/bmj-2025-085547.
To review the evidence base, clinical performance claims, and usability and safety of self-tests available for sale on the UK high street.
Cross sectional review of self-tests-regulation, evidence of performance, usability, and safety.
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.
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.
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.
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.
回顾英国商业街在售的自检产品的证据基础、临床性能声明以及可用性和安全性。
对自检产品的监管、性能证据、可用性和安全性进行横断面审查。
2023年，从伯明翰大学埃奇巴斯顿校区半径10英里范围内的超市、药店以及健康与养生商店中识别出相关检测产品。
总结自检产品的准确性声明、用于得出准确性测量结果的样本以及监管要求。评估了对设备和说明书在人体工程学、可用性和安全性方面的担忧，包括可解释性和可读性。总结了临床和非专业人士研究报告的详细信息（人群、样本量、参考或对照检测、检测过程），并使用诊断研究质量评估2（QUADAS - 2）工具对方法进行评估。
识别出35种自检产品（获取到30种），这些产品使用了7种不同的样本类型，并检测20种不同的生物标志物。24/30的检测产品在使用说明书中给出了准确性声明：19种产品声明了准确性，17种声明了敏感性，16种声明了特异性。53%（10/19）的检测产品在准确性方面声明≥98%，41%（7/17）在敏感性方面，63%（10/16）在特异性方面。在使用说明书中报告了参考标准的情况下，29%（5/17）的产品将自检产品与类似的快速检测进行了准确性评估。在可用性或安全性方面，18/30的自检产品至少存在一个高风险问题，11个是由于设备问题，10个是由于采样过程，15个是由于说明书或解释。获取到9套临床和非专业人士研究报告（涵盖12种检测产品）。在所有文档（9份临床研究报告和6份非专业人士研究报告）以及QUADAS - 2领域中，73%因报告不佳被评为存在偏倚风险不明，58%因研究设计不当被评为存在高适用性担忧。临床研究报告中参与者描述尤其不足。即使在非专业人士研究报告中，呈现的人口统计学信息也很少（最多4项）。一些人群不能代表目标用户，使用了不恰当的参考标准和阈值，且很少提及盲法。
本次调查强调需要加强监管监督并制定更清晰的标准，以确保英国市场上自检产品的安全性和可靠性。对其人体工程学和可用性的担忧可能导致检测错误。制造商不愿公开研究文档引发了伦理问题。此外，现有文档中研究设计和报告不充分，阻碍了评估支持自检产品使用的证据基础的能力。随着自检产品的可及性和使用持续增加，迫切需要加强监管监督以保护公众免受性能不佳的诊断自检产品的影响。
