Novel Malaria Test Sets a New Gold Standard for Diagnosis

Malaria is no longer only a disease of sub-Saharan Africa and southern Asia. Increasing numbers of people emigrating from countries where malaria is endemic have resulted in a higher incidence in Europe and the Middle East. The proportion of imported malaria cases has increased during the last few years from 14% to 86% in more recent studies.

The diagnosis of malaria in most developing countries has relied on parasites being identified by examining under the microscope a drop of the patient's blood, spread out as a "blood smear" on a microscope slide by a specialist. The introduction of rapid diagnostic tests (RDTs) has the potential to significantly improve management of malaria infections, especially in remote areas with limited access to good quality microscopy services, but their sensitivity has been questioned.

The recently CE Marked, illumigene Malaria (Meridian Bioscience; Cincinnati, OH, USA) is a novel, highly accurate test that targets a region of the Plasmodium genome that is conserved across P. falciparum, P. vivax, P. ovale, P. malariae, and P. knowlesi. Results from illumigene Malaria assays are intended to be used as an aid in the diagnosis of human malaria infection. The test does not require specialized laboratory equipment. The test demonstrated 100% sensitivity, but more importantly, it also detected infected patients that were missed by conventional methods for the identification of malaria. The illumigene Malaria, is a novel, highly accurate test developed by Meridian with the technical assistance of the Centers for Disease Control and Prevention (CDC; Atlanta, GA, USA) and Cheikh Anta Diop University (Dakar, Senegal).

The test is up to 80,000 times more sensitive at detecting the malaria parasite than conventional tests, potentially revolutionizing malaria diagnosis and establishing a new gold standard. Using innovative molecular Loop mediated isothermal amplification (LAMP) technology, illumigene results are available in less than one hour, and the test is easy to use as it does not rely on high-level technical expertise. This is a major step forward for people with malaria, as faster and more accurate diagnoses should lead to prompt treatment and better outcomes. The illumigene Malaria DNA amplification assay is performed on the illumipro-10, for the direct detection of Plasmodium spp. DNA in human venous EDTA whole blood specimens from individuals with signs and symptoms of malarial infection.

The illumigene Malaria molecular test uses LAMP technology to amplify DNA and detect the presence of the malaria parasite. LAMP technology is isothermal, therefore can be used at room temperature without the need to heat reagents or the material being tested, unlike some rapid diagnostic tests currently used in malaria which use polymerase chain reaction (PCR) technology and illumigene Malaria does not require refrigeration. illumigene Malaria will be distributed in the European, Middle Eastern and African regions by Meridian Bioscience Europe (Milan, Italy) and in additional international markets by the Company’s global distribution network.

Related Links:
Meridian Bioscience 
Centers for Disease Control and Prevention 
Meridian Bioscience Europe