Guidance on control materials for antigen detecting malaria RDTs: tools for preparation and validation

Overview

This document includes a work plan and possible strategies (annexes 1-5) to prepare and validate appropriate controls for monitoring the state of malaria rapid diagnostic tests (RDTs) and demonstrates why the approach described herein is necessary. It is based on HRP2 antigens, but the situation is identical for other antigens.

This document provides guidance specifically for product developers and manufacturers.