Castro Maria Del Mar, Ismail Horeya M, Montenegro-Quiñonez Carlos Alberto, Reipold Elena Ivanova, Shilton Sonjelle, Denkinger Claudia, Yerlikaya Seda
Department of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany
German Center for Infection Research (DZIF), Partner Site Heidelberg, Heidelberg, Germany.
BMJ Open. 2025 Aug 6;15(8):e092774. doi: 10.1136/bmjopen-2024-092774.
Novel diagnostics, particularly point-of-care (POC) tests, play a crucial role in the early detection and management of infectious diseases, especially in resource-limited settings. Ensuring test performance and quality while minimising the risk of human error becomes more relevant when shifting testing tasks from highly controlled settings like centralised laboratories to people with minimal training. Applying usability and human factors engineering principles can reduce the challenges related to human errors. Despite existing frameworks and tools, the practical application of usability guidelines remains variable across different settings.
This scoping review protocol outlines a systematic investigation of current practices in assessing the usability of novel diagnostics, particularly POC tests for infectious diseases intended for use in low-income and middle-income countries. The review will analyse original research studies of all designs and product dossiers that report on the usability evaluation or validation of a diagnostic test for an infectious disease. A qualitative synthesis of the data extracted from the articles will be conducted. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols and the Joanna Briggs Institute guidelines for this scoping review.
No ethical approval is required because individual patient data will not be included. The findings will be disseminated through publication in a peer-reviewed journal.
新型诊断方法，尤其是即时检验（POC），在传染病的早期检测和管理中发挥着关键作用，特别是在资源有限的环境中。当检测任务从高度受控的环境（如集中实验室）转移到训练有限的人员手中时，确保检测性能和质量并将人为错误风险降至最低变得更加重要。应用可用性和人因工程学原理可以减少与人为错误相关的挑战。尽管有现有的框架和工具，但可用性指南的实际应用在不同环境中仍存在差异。
本范围综述方案概述了对评估新型诊断方法（特别是用于低收入和中等收入国家的传染病即时检验）可用性的当前实践进行系统调查。该综述将分析所有设计的原始研究以及报告传染病诊断测试可用性评估或验证的产品档案。将对从文章中提取的数据进行定性综合分析。本范围综述将遵循系统评价和Meta分析方案的首选报告项目以及乔安娜·布里格斯研究所的指南。
无需伦理批准，因为不会纳入个体患者数据。研究结果将通过在同行评审期刊上发表进行传播。
