Target product profile – developing in vitro diagnostics for low- and middle-income settings

Overview

This target product profile provides a comprehensive set of generic characteristics to guide the development or adaptation of in vitro diagnostics (IVDs) for use in low- and middle-income settings. It addresses limitations in access to diagnostics and the challenges posed by products designed primarily for settings with greater infrastructure and resources. The document is intended to inform manufacturers during product design and research and development, support national and global programmes developing IVD-related guidance, and assist WHO technical units in preparing consistent biomarker- or disease-specific target product profiles.