Comprehensive molecular test introduced for diagnosis of malaria caused by P. vivax parasites

Human Diagnostics Worldwide (HUMAN), EIKEN CHEMICAL CO., LTD. (EIKEN) and the Foundation for Innovative New Diagnostics (FIND) announced today 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. The test was unveiled at the sixty-seventh annual meeting of the American Society of Tropical Medicine and Hygiene in November 2018.

Eliminating malaria is a global health priority, but without effective diagnostics it just cannot happen. P. vivax is challenging to diagnose, and this test represents an important new tool that can support elimination efforts.”

Catharina Boehme, CEO of FIND

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%, a specificity of >92% and a limit of detection of 1–2 parasites/µL.

We are pleased to be the exclusive distributor for EIKEN’s newly developed test for detecting P. vivax infections and to provide access to a reliable diagnosis through our worldwide network.”

Dr. Petra Rehberger, Vice President Marketing & Strategic Purchase at HUMAN