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.

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While equipment-free visual interpretation is a benefit of lateral-flow assays, automating the reading of rapid diagnostic tests promotes proper test performance, interpretation and reporting of the results. We have created a target product profile that describes the minimal and optimal characteristics of various rapid diagnostic test readers. The product profile is intended to promote the development of effective, useful, sustainable rapid diagnostic test readers in support of health programmes worldwide. These readers may be custom hardware or software-only running on a general-purpose mobile device, for professional or lay use, and for medical or non-medical purposes. During the development of the product profile, the World Health Organization and FIND convened a development group of 40 leading scientists, experts, public health officials and regulators. We held a public consultation to which 27 individuals or organizations responded. The product profile calls for rapid diagnostic test readers that at minimum should: (i) interpret colorimetric tests with at least 95% agreement with expert visual interpretation; and (ii) automatically report results and associated data for the health programme. Optimally, readers should: (i) provide at least 98% agreement; (ii) operate with multiple models of rapid diagnostic tests; (iii) assist the user in performing each rapid diagnostic test according to the test instructions; and (iv) offer multiple configurations, operating modes and languages to suit the needs of diverse users, settings and health programmes.