FDA approves quick malaria test
June 27, 2007The U.S. Food and Drug Administration has approved the Binax NOW Malaria Test, the first rapid test authorized for laboratory use in the United States.
Standard laboratory tests for malaria require identifying parasites in a blood sample under a microscope -- a difficult task requiring training and experience.
The FDA said the new test is significantly faster and easier to use, producing results 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 virulent malaria parasites. Results, however, still need to be confirmed using standard microscopic evaluation, the FDA noted.
Malaria was eliminated in the United States during the 1950s but citizens can become infected while traveling in other countries. There were 1,528 new U.S. cases of malaria reported during 2005, including seven deaths. The FDA said nearly all deaths can be prevented if the infection is diagnosed and treated early.
FDA scientists found the Binax NOW test was 95 percent accurate compared with standard microscopic diagnosis in a multi-center study.
The test is manufactured by Binax Inc., a subsidiary of Inverness Medical Innovations Inc.
Copyright 2007 by United Press International
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