Target product profile: developing in vitro diagnostics for low- and middle-income settings
Loading...
Date
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
World Health Organization
Abstract
Description
x, 38 p.
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. The publication defines acceptable and desirable characteristics across four testing contexts: instrument-free disposable tests in facilities without clinical laboratories; self-testing IVDs; instrument-based point-of-care technologies in facilities without clinical laboratories; and IVDs used in facilities with clinical laboratories. It covers operational requirements, test results, data and connectivity, quality, safety, regulatory considerations, training, maintenance and other product characteristics relevant to resource-limited settings. The profiles are generic and intended for adaptation to specific diseases, biomarkers, populations and use cases.
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. The publication defines acceptable and desirable characteristics across four testing contexts: instrument-free disposable tests in facilities without clinical laboratories; self-testing IVDs; instrument-based point-of-care technologies in facilities without clinical laboratories; and IVDs used in facilities with clinical laboratories. It covers operational requirements, test results, data and connectivity, quality, safety, regulatory considerations, training, maintenance and other product characteristics relevant to resource-limited settings. The profiles are generic and intended for adaptation to specific diseases, biomarkers, populations and use cases.