Target product profile for readers of rapid diagnostic tests

Abstract

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.