Dengue Fever Assay Gets FDA Marketing Nod

Neil Osterweil

April 11, 2011

April 11, 2011 — An antibody test for dengue fever/dengue hemorrhagic fever has received marketing approval, the US Food and Drug Administration (FDA) announced on Friday.

The DENV Detect IgM capture enzyme-linked immunosorbent assay is the first test approved to aid in the diagnosis of dengue fever, a mosquito-borne viral infection that is most commonly seen in the United States among travelers returning from Latin America, the Caribbean, and Southeast Asia. The disease is endemic in Puerto Rico, the Virgin Islands, and US territorial islands in the Pacific.

Dengue outbreaks have recently been reported in Florida, Hawaii, and Texas, according to the US Centers for Disease Control and Prevention.

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

Dengue is also known as "break-bone" fever for its tendency to cause severe myalgia and bone pain. The disease has an acute onset that generally follows milder symptoms, including headache, fever, exhaustion, lymphadenopathy, and rash. A triad of fever, rash, and headache accompanied by other pains is suggestive of dengue infection.

The newly approved assay detects antibodies to dengue virus in blood samples from patients with signs and symptoms of infection. The test will be available to clinical laboratories.

The FDA cautions that the assay is not a direct test for the arbovirus strains that cause dengue. Instead, it detects an IgM antibody response that is not detectable until 3 to 5 days after the onset of fever. In addition, the test may cross-react with similar viruses, such as West Nile viruses.

"However, in most patient testing situations found in the United States, a positive test result in a patient with signs or symptoms consistent with dengue should be considered presumptive evidence of dengue," the agency states.

More information is available on the FDA Web site.

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