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INTENDED USE

TheMalaria Gold Rapid Test is a lateral flow chromatographic

immunoassay for the simultaneous detection and differentiation of antibodies including IgG, IgM and IgA to Plasmodium falciparum (Pf) and vivax, ovale, and malariea (Pv.o.m) in human serum, plasma or whole blood. This device is intended to be used as a screening test and as an aid in the diagnosis of infection with Plasmodium. Any reactive specimen with the Malaria Gold Rapid Test must be confirmed with alternative testing method(s) and clinical findings.