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The Binax NOW® Malaria Test is an in vitro immunochromatographic assay for the qualitative detection of Plasmodium antigens circulating in human venous and capillary EDTA whole blood of individuals with signs and symptoms of malarial infection. The test targets the histidine-rich protein II (HRPII) antigen specific to Plasmodium falciparum (P.f.) and a pan-malarial antigen, common to all four malaria species capable of infecting humans - P. falciparum, P. vivax (P.v.), P. ovale (P.o.), and P. malariae (P.m.). It is intended to aid in the rapid diagnosis of human malaria infections and to aid in the differential diagnosis of Plasmodium falciparum (P.f.) infections from other less virulent malarial infections. Negative results must be confirmed by thin / thick smear microscopy. The Binax NOW® Malaria Test is for the laboratory diagnosis of malaria in individuals with signs and symptoms consistent with malaria infection.

In vitro immunochromatographic immunoassay The Binax NOW® Malaria Test is an immunochromatographic membrane assay that uses monoclonal antibodies to detect Plasmodium falciparum antigen and pan-malarial antigen (an antigen shared by all Plasmodium species causing human malaria) in venous and capillary whole blood specimens. These antibodies, and a control antibody, are immobilized on a membrane support as three distinct lines and are combined with a sample pad, which is impregnated with visualizing particles conjugated to control and anti-malarial antibodies, to create a test strip. This test strip is mounted in a book-shaped. hinged test device, along with wash and absorbent pads, intended to aid in the clearing of the membrane when the device is closed. To perform the test, whole blood is applied to the sample pad. Malarial antigen present in the sample reacts to bind the anti-malaria conjugated antibody. Reagent A is added to the bottom of the test strip and allows the antigen-conjugate complexes to migrate along the test strip, where they are captured by the immobilized antibodies, forming the Test Line(s). Immobilized control antibody captures control conjugate, forming the Control Line. Once the blood sample has migrated the length of the test strip, the device is closed, allowing Reagent A that has been added to the wash pad to clear the test strip of excess blood. Test results are interpreted by the presence or absence of visually detectable pink-to-purple colored lines. A positive test result, read in 15 minutes, will include the detection of both a Test Line (or Test Lines) and a Control Line. A negative test result, read in 15 minutes, will produce only a Control Line, indicating that malarial antigens were not detected in the sample. Failure of the Control Line to appear, whether the Test Line(s) is present or not, indicates an invalid result.