- © 2007 Canadian Medical Association
The first rapid malaria test approved by the US Food and Drug Administration is now on the market, intended for laboratory use.
The FDA approved Binax NOW on June 13, calling it “significantly faster and easier to use” than existing methods of diagnosing malaria, says spokesperson Karen Riley. “Having test results sooner will help minimize delays in treating patients and prevent unnecessary medical treatment,” she told CMAJ in an email interview. “The test is able to differentiate Plasmodium falciparum infections from other less virulent malarial infections.”
Other rapid malaria tests are marketed, but this is the first with FDA approval. The standard laboratory diagnosis of malaria involves microscopic identification of malaria parasites in blood. This method requires trained and experienced technicians. The Binax NOW test requires only a few drops of whole blood on a dipstick and can yield results in 15 minutes.
“Clinical sensitivity and specificity of the Binax NOW(r) test when compared to microscopy was 95% and 94%, respectively for Plasmodium falciparum infected samples,” says Riley. Negative results, however, should be “confirmed by microscopy.”
Manufacturer Binax Inc. says the test sells for US$10–$29, depending on where in the world it is being purchased. It will be particularly useful in North America, says Davidson H. Hamer, associate professor of International Health and Medicine at the Boston University Schools of Public Health and Medicine. “Since there is substantial evidence that many hospitals in the US and Canada do not have microscopists with a high level of technical skill to read and interpret malaria blood smears, the availability of a rapid diagnostic test provides an alternative approach to the rapid and correct diagnosis of malaria.”