The Diagnostic Kit for Malaria Pf/Pv Antigen is a lateral flow chromatographic immunoassay for the qualitative detection of Plasmodium falciparum specific histidine-rich protein-II (Pf HRP-II) and malaria pLDH specific lactate in whole blood. This assay provides only a preliminary qualitative test result. The device is intended to be used as a screening test and as an aid in the diagnosis of infection. Any reactive specimen with the Diagnostic Kit for Malaria Pf/Pv Antigen must be confirmed with alternative testing methods and clinical findings.