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.