Malaria Rapid Diagnostic Test Products: Suggested Use of Terms, Requirements and Preferences for Labelling and Instructions for Use. Geneva: World Health Organization; 2017
(2017; 39 pages)

Abstract

Rapid diagnostic tests (RDTs) largely account for the scale-up of malaria diagnosis in endemic settings. However, diversity in terminology, labelling and the instructions for use (IFU) limits their interchangeability and user friendliness. Uniform, easy to follow and consistent terminology and labelling, aligned with international standards and appropriate for the level of the end user’s education and training, is crucial. This document is intended as a reference for malaria RDT manufacturers and follows on from the consensus building efforts of a 2014 Roll Back Malaria Partnership stakeholder consultation and special taskforce to harmonize terms and abbreviations as well as specifications for labelling of box, device packaging, cassettes, buffer bottle and accessories. Specifically, this reference indicates if WHO considers these specifications are requirements based on international standards or preferences based on the outcome of consultations with country programme implementers, experts in RDT implementation, IVD regulatory experts and manufacturers. These requirements and preferences are aligned with those of the WHO Prequalification (PQ) of IVDs programme and compliance will be monitored through the dossier and laboratory evaluation components of the WHO PQ process.

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