1st U.S. Test to Diagnose Dengue Fever Approved

MONDAY, April 11 (HealthDay News) — The first test to help diagnose people with symptoms of the mosquito-borne virus dengue fever has been approved by the U.S. Food and Drug Administration.

As many as 100 million people globally are believed infected each year with the virus, transmitted by Aedes mosquitoes, the FDA said in a news release. Symptoms include high fever, severe headache and pain behind the eyes, pain in the joints, muscles and bones, rash, and easy bleeding and bruising.

Most cases in the continental United States can be traced to people returning from Latin America, the Caribbean and Southeast Asia. It’s also common in Puerto Rico and the Virgin Islands. Recent dengue outbreaks have been reported in Hawaii, Texas and Florida, the FDA said.

The DENV Detect IgM Capture ELISA test detects dengue antibodies in the blood. The test is based on technology developed by the U.S. Centers for Disease Control and Prevention, and is manufactured by Inbios Inc., of Seattle.

The test should not be used in people who do not have any symptoms of dengue fever, the FDA warned. There are no FDA-approved vaccines to prevent the infection or medicines approved specifically to treat it, the agency said.

More information

The CDC has more about dengue fever.