Foundation for Innovative Diagnostics (FIND), Geneva, Switzerland.
Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
PLoS One. 2020 Jan 29;15(1):e0228311. doi: 10.1371/journal.pone.0228311. eCollection 2020.
The essential role of rapid diagnostic tests (RDTs) in disease control is compromised every time a test is not performed correctly or its result is not reported accurately and promptly. A mobile app that utilizes the camera and connectivity of a common smartphone can fill this role of supporting the test's proper execution and the automatic transmission of results. In a consensus process with 51 expert participants representing the needs of clinical users, healthcare programs, health information systems, surveillance systems, and global public health stakeholders, we developed a Target Product Profile describing the minimal and optimal characteristics of such an app. We collected feedback over two rounds and refined the characteristics to arrive at a preferred agreement level of greater than 75%, with an average of 92% agreement (range: 79-100%). As per this feedback, such an app should be compatible with many RDTs and mobile devices without needing accessories. The app should assist the user with RDT-specific instructions, include checks to facilitate quality control of the testing process and suggest results with ≥ 95% accuracy across common lighting conditions while allowing the user to determine the final result. Data from the app must be under the control of the health program that operates it, and the app should support at least one of the common data exchange formats HL7, FHIR, ASTM or JSON. The Target Product Profile also lays out the minimum data security and privacy requirements for the app.
每次快速诊断检测（RDT）的检测不正确或检测结果不准确或不及时报告时，都会影响到疾病控制中 RDT 的重要作用。一款利用普通智能手机的摄像头和连接功能的移动应用程序可以填补这一空白，支持检测的正确执行和结果的自动传输。我们与 51 名代表临床用户、医疗保健项目、健康信息系统、监测系统和全球公共卫生利益相关者需求的专家参与者进行了共识流程，制定了一个目标产品档案，描述了此类应用程序的最小和最佳特征。我们通过两轮收集了反馈信息，并对这些特征进行了细化，达成了超过 75%的首选协议水平，平均协议水平为 92%（范围：79-100%）。根据这一反馈，此类应用程序应与许多 RDT 和移动设备兼容，而无需使用配件。该应用程序应能为用户提供特定于 RDT 的说明，包括检查以促进检测过程的质量控制，并在常见照明条件下建议准确率≥95%的结果，同时允许用户确定最终结果。应用程序的数据必须由操作它的卫生项目控制，该应用程序应至少支持 HL7、FHIR、ASTM 或 JSON 等常见数据交换格式之一。目标产品档案还为应用程序规定了最低的数据安全性和隐私要求。
