At a meeting jointly organized by the Roll Back Malaria Partnership and the Institute of Tropical Medicine in Antwerp, manufacturers and implementers of rapid diagnostic tests (RDTs), used to diagnose malaria at the point of care, agreed on a set of required features for RDTs in an effort to improve use and boost the scale up of malaria testing.
Manufacturers, donors and regulatory experts, including from the World Health Organization (WHO) and the Global Fund, as well as country implementers, assessed the interchangeability and user friendliness of nearly 60 different RDTs on the market, and generated a prioritized a list of RDT requirements to meet country needs.
John Oluoch Nyamuni of the Ministry of Health in Kenya said: “With easily identifiable, interchangeable and user friendly RDTs we can dramatically increase the testing of malaria – which will result in more rational administration of antimalarial medicines. This makes our malaria control budgets go much further. Harmonization will also help countries to buy a quality product.”
Currently RDTs vary in diagnostic performance, manner of use, and price. Countries prefer to stay with the same RDT rather than go through the costly exercise of retraining thousands of health workers, or run the risk of error in the manipulation of the test, which can detect malaria parasites in a tiny drop of blood. This can result in a stagnant market which does not attract the development of improved quality products.
According to the World Malaria Report launched this week by the World Health Organization, the numbers of procured rapid diagnostic tests is increasing, as is the reported rate of diagnostic testing in the public sector in the African Region, which increased from 37% in 2010 to 61% in 2012, and from 44% to 64% globally.
Most of the increase in testing in the African Region is due to increased use of RDTs, which accounted for 40% of all cases tested in the region in 2012.
However, millions of people with suspected malaria still do not receive a diagnostic test, and many people with confirmed infections do not receive appropriate malaria treatments. “This latest move to harmonize rapid diagnostic tests will help all countries to implement the WHO recommendations to “test, treat and track” malaria – and build the trust of health workers in the accuracy of the malaria test results,” said RBM Executive Director Dr. Fatoumata Nafo who addressed the gathering. “By bringing together manufacturers, technical experts and end users, we can improve these lifesaving tools, improve market flexibility and advance the scale up of malaria diagnosis and treatment.”
Over the past one and a half years, an international group of researchers coordinated by Prof. Jan Jacobs of the Institute of Tropical Medicine in Antwerp assessed similarities and differences between commercially available RDTs. The research was commissioned by the Roll Back Malaria Partnership. “We found that many of the shortcomings, such as confusing names, unclear and non-consistent labeling and terminology, variations in design and test procedures can be overcome in the short term. Field observations show that even small things like the readability of the test instructions can make the difference between a correct and a failed test,” said Prof. Jacobs. “Harmonization will also benefit manufacturers. History shows that harmonization boosts business and market, while a level playing field protects producers from unfair competition from cheaper but substandard products,” he added.
The efforts to harmonize RDTs will help to accelerate the implementation of universal diagnostic testing in the public and private sectors, reduce the global requirements for antimalarial treatment and advance progress towards the Roll Back Malaria Partnership goal of near-zero malaria deaths by 2015.