FDA allows marketing of first test to diagnose dengue fever

The U.S. Food and Drug Administration has allowed the marketing of the first test to help diagnose people with symptoms of dengue fever or dengue hemorrhagic fever, a major cause of illness in the tropics.

The DENV Detect IgM Capture ELISA test can detect antibodies to dengue virus in blood samples from patients who have symptoms and signs of dengue. The test will be available for use in clinical laboratories. It can assist in the diagnosis and subsequently the patient care and management of dengue.

Dengue testing is complicated by the fact that an IgM antibody response to dengue virus is not detectable until three to five days after the onset of fever. There is no FDA-cleared or approved test that directly detects the dengue virus.

“Cases of dengue fever or dengue hemorrhagic fever can be potentially fatal for people who do not recognize the symptoms,” Alberto Gutierrez, director of the Office of In Vitro Diagnostics Device Evaluation and Safety in FDA’s Center for Devices and Radiological Health, said. “This test will now aid health care professionals in their effort to more effectively diagnose dengue.”

The dengue virus spreads to humans by infected Aedes mosquitoes. As many as 100 million people worldwide are infected by the virus each year. Symptoms include high fever, severe pain behind the eyes, severe headache, joint pain, rash, muscle and bone pain, easy bruising and mild bleeding involving the gums or nose.

Most dengue cases reported in the continental United States occur in people returning from travels to tourist destinations in the Caribbean, Latin America and Southeast Asia. Dengue is endemic in the Virgin Islands and Puerto Rico.