 |
 |
 |
|
 |
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
Consumer Update |
The first authorized U.S. rapid test for detecting malaria has been cleared for marketing by FDA. The Binax NOW Malaria Test is intended for laboratory use.
Malaria is a disease caused by a parasite that is carried by a type of mosquito. Standard laboratory tests for malaria require identifying the 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 blood are placed on a dipstick. The test can also distinguish the most dangerous malaria parasite, Plasmodium falciparum, from less dangerous ones. Results still need to be confirmed using standard microscopic evaluation.
"Since malaria is uncommon in the United States, clinicians and lab personnel may not be accustomed to diagnosing this disease," says Daniel Schultz, M.D., Director of FDA's Center for Devices and Radiological Health. "When used in combination with other laboratory tests, the Binax NOW test provides an additional tool to help them diagnose this disease faster in the United States."
The Binax NOW test was 95% accurate compared with standard microscopic diagnosis in a study outside the United States in areas where malaria is prevalent.
The Binax NOW test is manufactured by Binax Inc.of Scarborough, Maine, a subsidiary of Inverness Medical Innovations Inc.
Although malaria has been eliminated from the United States since the 1950s, it can still affect U.S. residents who travel or work in other countries. People infected with the parasites often experience:
Left untreated, people may develop severe complications and die.
According to the Centers for Disease Control and Prevention, there were more than 1,500 newly reported cases of malaria in the United States in 2005, including 7 deaths. Nearly all deaths can be prevented if the infection is diagnosed and treated early.
For more information on malaria, visit www.cdc.gov/malaria/.
Date Posted: June 27, 2007
