FDA OKs Test for Dengue Fever

April 13, 2011 -- The FDA has approved a test to diagnose people with dengue fever, a sometimes deadly viral illness spread by mosquitoes.

The virus is transmitted by an infected mosquito. Most cases in the continental U.S. can be traced to people returning from the Caribbean, Latin America, and Southeast Asia, the FDA says in a statement.

About 100 million people are infected by the virus each year worldwide, according to the CDC.

The disease is common in the Virgin Islands and Puerto Rico, but outbreaks have also have been reported in Florida, Texas, and Hawaii.

The new test is being manufactured by Seattle-based Inbios Inc. The test, known as the DENV Detect IgM Capture ELISA, finds dengue fever antibodies in the blood of patients who have symptoms of the infection.

The symptoms of dengue fever include high fever; severe headache; pain behind the eyes; pain in the joints, muscles, and bones; rash; easy bruising; and mild bleeding of the nose or gums.

The test will be available for use in clinical laboratories.

“Cases of fever or dengue hemorrhagic fever can be potentially fatal for people who do not recognize the symptoms,” says Albert Gutierrez, PhD of the FDA’s Center for Devices and Radiological Health. “This test will now aid health care professionals in their efforts to more effectively diagnose dengue.”

Who Should Get the New Test

The FDA says people who think they might have dengue fever should contact a health care professional immediately. Currently there are no FDA-licensed vaccines to prevent dengue fever and no medicines have been approved specifically to treat the infection.

The FDA says the test should not be used in people who show no signs or symptoms of dengue fever. It says diagnostic testing is complicated by the fact that an antibody response to dengue virus infection is not detected until three to five days after the onset of fever, which can result in a negative test even if the person has dengue fever.

The FDA says the new test may have a positive result when a person has a closely related virus, such as the virus that causes West Nile disease. But in most testing situations in the U.S., the FDA says, a positive test result in a person with signs or symptoms of dengue fever should be considered presumptive evidence of the disease.