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Binaxnow Malaria Test | Clia Waived Rapid Testing

Inverness Medical Innovations, Inc.

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Inverness Medical Innovations, Inc. Inverness Medical Logo
Inverness Medical Innovations, Inc. Inverness Medical Logo
The BinaxNOW® Malaria Test is a rapid field or 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.

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The BinaxNOW® Malaria Test is a rapid field or 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 a rapid immunodiagnostic assay for the differentiating detection of circulating Plasmodium falciparum (P.f.) antigen and the antigen common to all to Pan malarial species: Plasmodium vivax (P.v.), Plasmodium ovale (P.o.), and Plasmodium malariae (P.m.) in whole blood.

This product is CE Marked.
This product has been cleared for sale in the US by the FDA

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 trial.


Catalog Number
US Only
665-000 (12 test kit)
665-025 (25 test kit)

International
660-000 (25 Test kit)
Product Information


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