The Alethia Malaria and Alethia Malaria PLUS DNA amplification assays, performed on the Alethia Incubator/Reader®, are qualitative in vitro diagnostic tests for the direct detection of Plasmodium sp. DNA in human venous EDTA whole blood specimens from individuals with signs and symptoms of malarial infection. Results from Alethia Malaria assays are intended to be used as an aid in the diagnosis of human malaria infection