Malaria rapid diagnostic test products: Suggested use of terms, requirements and preferences for labelling and instructions for use

Overview

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 limits their interchangeability and userfriendliness. 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: it 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, in vitro diagnostics (IVD) regulatory experts and manufacturers. These requirements and preferences are aligned with those of the WHO Prequalification (PQ) of IVDs programme.