Malaria rapid diagnostic tests
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World Health Organization
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iv, 21 p.
This technical specifications document provides guidance for manufacturers seeking WHO prequalification of rapid diagnostic tests (RDTs) intended for the detection of Plasmodium antigens in blood for the diagnosis of symptomatic malaria infection. Developed within the WHO Technical Specifications Series for diagnostic assessment, the publication defines the analytical and clinical performance evidence required for product dossier submissions in accordance with the International Medical Device Regulators Forum Table of Contents format. It addresses intended use statements, specimen requirements, operational settings, analytical sensitivity and specificity, usability, stability, and clinical evaluation studies for malaria RDTs used in resource-limited settings. The document establishes minimum performance and study requirements for assays detecting Plasmodium falciparum, Plasmodium vivax and pan-specific malaria antigens, including considerations related to HRP2/3 gene deletions, point-of-care use, and testing by trained lay providers and health-care workers. Detailed requirements are presented for specimen validation, precision studies, limit of detection, interference and cross-reactivity testing, robustness, shelf-life studies, and clinical sensitivity and specificity assessments. The publication also references related WHO guidance and international standards relevant to the quality, safety and regulatory evaluation of malaria rapid diagnostic tests.
This technical specifications document provides guidance for manufacturers seeking WHO prequalification of rapid diagnostic tests (RDTs) intended for the detection of Plasmodium antigens in blood for the diagnosis of symptomatic malaria infection. Developed within the WHO Technical Specifications Series for diagnostic assessment, the publication defines the analytical and clinical performance evidence required for product dossier submissions in accordance with the International Medical Device Regulators Forum Table of Contents format. It addresses intended use statements, specimen requirements, operational settings, analytical sensitivity and specificity, usability, stability, and clinical evaluation studies for malaria RDTs used in resource-limited settings. The document establishes minimum performance and study requirements for assays detecting Plasmodium falciparum, Plasmodium vivax and pan-specific malaria antigens, including considerations related to HRP2/3 gene deletions, point-of-care use, and testing by trained lay providers and health-care workers. Detailed requirements are presented for specimen validation, precision studies, limit of detection, interference and cross-reactivity testing, robustness, shelf-life studies, and clinical sensitivity and specificity assessments. The publication also references related WHO guidance and international standards relevant to the quality, safety and regulatory evaluation of malaria rapid diagnostic tests.