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Malaria

FDA Clears for Marketing First Quick Test for Malaria

Published in Medical Letter on the CDC and FDA, July 15th, 2007

The U.S. Food and Drug Administration has cleared for marketing the Binax NOW Malaria Test, the first authorized U.S. rapid test for malaria, a mosquito-borne disease caused by a parasite. The test is intended for laboratory use.

Standard laboratory tests for malaria require identifying parasites in a blood sample under a microscope, a difficult task that requires training and experience.

The Binax NOW test is significantly faster and easier to use. Results are available in 15 minutes after a few drops of whole blood are placed on a dipstick. The test can also differentiate the most dangerous malaria parasite, Plasmodium falciparum, from less...

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