Human Diagnostics Worldwide (HUMAN), EIKEN CHEMICAL CO., LTD. (EIKEN) and the Foundation for Innovative New Diagnostics (FIND) announced the launch of the first commercially available molecular diagnostic test for the detection of malaria caused by Plasmodium vivax parasites. Malaria-LAMP is a molecular test that works using loop-mediated isothermal amplification (LAMP), developed by EIKEN with exclusive distribution by HUMAN. FIND evaluated the prototype test in collaboration with the Hospital for Tropical Diseases in London, UK, and coordinated in-country clinical performance studies in Colombia and Peru.
Malaria is an urgent public health threat, with 2.5 billion people at risk globally. Of the five malaria species, P. vivax is geographically the most widespread form of disease. It accounts for more than half of all malaria cases outside sub-Saharan Africa, but control strategies to date have focused on Plasmodium falciparum. P. vivax malaria is not easy to detect, largely due to much lower densities of parasites in the blood compared with P. falciparum and, unlike P. falciparum, P. vivax parasites can lie dormant in the liver and cause relapses. However, the proportion of malaria due to P. vivax is increasing in many regions; in 2017, a total of about 7.5 million cases of P. vivax occurred worldwide.
To control malaria caused by P. vivax, sensitive and reliable tools are needed, especially in areas close to elimination. Different species require different treatment strategies, but while current diagnostic tests can identify P. falciparum, they are generally not able to differentiate between the various malaria species. There is currently no diagnostic that can effectively detect inactive parasites in the liver – which is why effective and highly sensitive blood-stage diagnosis is key.
Malaria-LAMP is a comprehensive molecular solution introduced for the diagnosis of malaria. The test can differentiate between Plasmodium pan species, P. falciparum and P. vivax, and has a sensitivity of 84–94 percent, a specificity of >92 percent and a limit of detection of 1–2 parasites/µL.