Methods manual for laboratory quality control testing of malaria RDTs

Overview

This manual is intended primarily for internal use by laboratories implementing WHO-recognized malaria RDT lot testing procedures. It details a protocol for the production and use of quality control samples for quality control testing of malaria RDTs.

The manual describes a system for quality control designed to:

• qualitatively assess the suitability for field use of malaria RDTs designed to detect malaria parasite antigens in order to determine their suitability for use in diagnosis;
• provide quality control samples that are stable when transported and stored;
• provide transparency and consistency in the production and use of the quality control samples; and
• use technology and methods suitable for application in most national-level or regional-level laboratory facilities in malaria-endemic regions. 

This manual includes standard operating procedures for related areas (e.g. microscopy, laboratory practices), that are necessary to develop an adequate laboratory environment for malaria RDT quality control.