The 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.Alethia Malaria assays utilize loop-mediated isothermal DNA amplification (LAMP) technology to detect Plasmodium sp. DNA by targeting segments of the Plasmodium genome. Alethia Malaria assays do not distinguish between Plasmodium species.Alethia Malaria PLUS is intended for use in hospital, reference or state laboratory settings. The device is not intended for nonlaboratory point-of-care use.
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple species of Plasmodium (malaria parasites) in a clinical specimen, using a nucleic acid technique (NAT).
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