This publication is intended to help tuberculosis diagnostics researchers work more effectively with academics, officials and industry professionals. It offers a structure to guide those involved in diagnostic development through the different phases of development – from the discovery of new techniques and tools through to their delivery in previously neglected markets.
It is designed to help identify the most promising TB tests, to push them toward alignment with the needs and requirements of the areas where tuberculosis is most prevalent, and to help determine why some are held up in development. The blueprint also is intended to help boost coordination and collaboration across the diagnostic research and development landscape, while leading to greater success in advancing new tests by clarifying that landscape and the various development steps. Finally, considering the paucity of national regulations regarding the quality of diagnostics and the need for a strong evidence base to support health policy decisions, this blueprint seeks to inform and advance independent evaluation and assessment of the new tools’ likely impacts based on scientifically sound methodology, in addition to well-defined standards of practice for study design.
World Health Organization, Stop TB Dept, Geneva. ISBN: 978 92 4 159881 1. 151 pp.