Current malaria reference materials used to calibrate RDTs and evaluate their performance and quality are made from frozen blood samples, which can make them difficult to prepare, characterise and transport.

About the standard

The lyophilised WHO IS preparation (NIBSC product code 16/376) for the evaluation of performance and sensitivity of malaria antigen detection tests has been established at 1000 International Units of the P. falciparum antigens HRP-2 and pLDH per ampoule.

Prepared using P. falciparum cell cultures, the standard will be used worldwide to assure the quality and harmonization of existing malaria detection tests and support the development of better, more sensitive RDTs in future.

A collaborative study involving 13 laboratories worldwide confirmed the suitability of this IS for the detection of HRP2 and pLDH using a variety of RDTs and enzyme-linked immunosorbent assays (ELISA).

Building confidence in diagnosis

"Our new WHO IS aims to address some of the challenges with malaria RDTs and adds to our growing collection of diagnostic malaria standards for P. falciparum"
 
Dr Paul Bowyer, Principal Scientist at NIBSC

Ensuring that rapid diagnostic tests are reliable and accurate is key for their continued use. Dr Paul Bowyer, Principal Scientist at NIBSC, comments:

"Rapid diagnostic tests are widely used to diagnose malaria, as they are easy to use, even in remote areas. However, the ongoing development of new tests and the variability in results and performance of existing ones means that steps need to be taken to make sure that those using them are confident in their accuracy and ability to correctly diagnose the condition."

"This new WHO IS aims to address some of these challenges and adds to our growing collection of diagnostic malaria standards for P. falciparum, including DNA and serum standards."

"Following the success of this project, we will continue to work with FIND to produce a portfolio of standards for Plasmodium vivax, the second most common malaria parasite, to support the diagnosis of this species as well."

This project was also supported by funding from the Bill & Melinda Gates Foundation, the UK and Australian Governments.