The BinaxNOW^® Malaria Test is a rapid laboratory test for the differential diagnosis of a malaria infection. The simple, three-step test provides results in 15 minutes, allowing for accurate treatment and improved patient outcomes.

Intended Use

The BinaxNOW^® 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.

Product Details

• Availability – US and International
• Sample type – Whole blood
• Time for test results – 15 minutes

Sensitivity

• 99.7% (Plasmodium falciparum)*
• 93.5% (Plasmodium vivax)*

Specificity

• 94.2% (Plasmodium falciparum)
• 99.8% (Plasmodium vivax)

*For parasitemia levels >5,000 (parasites/ųl). Please refer to the Product Insert for complete performance data as established in clinical trials.