Diagnostic target product profiles for trachoma surveillance
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World Health Organization
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v, 14 p.
This publication presents target product profiles (TPPs) for diagnostic tools intended to support trachoma surveillance within programmes for the elimination of trachoma as a public health problem. Developed by WHO in collaboration with the Diagnostic Technical Advisory Group for Neglected Tropical Diseases and its trachoma subgroup, the document outlines the minimum and ideal characteristics required for diagnostics that detect evidence of past or present Chlamydia trachomatis infection. The publication responds to challenges associated with current surveillance methods, including limitations in the sensitivity and specificity of clinical grading, particularly in post-mass drug administration settings and areas with unusual epidemiological patterns. The document describes the epidemiology of trachoma, current public health strategies for elimination, and the role of diagnostic testing in surveillance and programmatic decision-making. It defines target product profiles for field-based and laboratory-based tests across three epidemiological contexts: newly suspected endemic areas, post-intervention surveillance, and settings with persistent or recrudescent disease transmission. Detailed specifications are provided for intended use, performance characteristics, operational requirements, sample types, infrastructure needs, quality control, cost considerations and regulatory aspects, with the aim of guiding diagnostic developers and supporting countries in strengthening trachoma surveillance activities.
This publication presents target product profiles (TPPs) for diagnostic tools intended to support trachoma surveillance within programmes for the elimination of trachoma as a public health problem. Developed by WHO in collaboration with the Diagnostic Technical Advisory Group for Neglected Tropical Diseases and its trachoma subgroup, the document outlines the minimum and ideal characteristics required for diagnostics that detect evidence of past or present Chlamydia trachomatis infection. The publication responds to challenges associated with current surveillance methods, including limitations in the sensitivity and specificity of clinical grading, particularly in post-mass drug administration settings and areas with unusual epidemiological patterns. The document describes the epidemiology of trachoma, current public health strategies for elimination, and the role of diagnostic testing in surveillance and programmatic decision-making. It defines target product profiles for field-based and laboratory-based tests across three epidemiological contexts: newly suspected endemic areas, post-intervention surveillance, and settings with persistent or recrudescent disease transmission. Detailed specifications are provided for intended use, performance characteristics, operational requirements, sample types, infrastructure needs, quality control, cost considerations and regulatory aspects, with the aim of guiding diagnostic developers and supporting countries in strengthening trachoma surveillance activities.