New Rapid Test for Malaria

FDA recently cleared for marketing a rapid test for malaria, called Binax NOW, that can produce results in 15 minutes. Standard tests take far more time and require identifying parasites in a blood sample using microscopy.

The new product can differentiate Plasmodium falciparum, which is the most dangerous malaria parasite, from the other three Plasmodium species that can infect humans. Negative results with the Binax NOW test will still need to be confirmed using microscopy.

The test should help to minimize delays in treating patients who have malaria, and prevent unnecessary treatment in patients with malaria symptoms who do not have the disease. It could be an important diagnostic tool in parts of the world where malaria is endemic and where there are not enough qualified personnel to read microscopic smears. U.S. physicians will be able to use the test in returning travelers with signs or symptoms of malaria.

The Binax NOW test was compared to microscopy in over 4,000 blood samples taken from patients with malaria-like symptoms in areas of the world where malaria is endemic. In these studies, the sensitivity of the rapid test was 95 percent, and its specificity was 94 percent.

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Tags:

• Malaria
• Test
• FDA
• Binax
• NOW