New CDC test for dengue approved by FDA

ATLANTA — A diagnostic test designed to detect the presence of dengue virus in people with symptoms of dengue fever or dengue hemorrhagic fever has been approved by the Food and Drug Administration, the Centers for Disease Control and Prevention announced Thursday.

The test, called the CDC DENV-1-4 Real Time RT PCR Assay, has been authorized by the Food and Drug Administration for use in the United States and can be performed using equipment and supplies many public health labs already use to diagnose influenza. The new test will help diagnose dengue within the first seven days after symptoms of the illness appear (which is when most people are likely to see a healthcare professional and the dengue virus is likely to be present in their blood). The test can identify all four dengue virus types. CDC officials said this marks the first FDA-approved molecular test for dengue that detects evidence of the virus itself.

"The need for the new dengue diagnostic test was high," said Jorge L. Munoz-Jordan, chief of the molecular diagnostics and research at the CDC dengue branch. "Patients will be diagnosed sooner than before, and public health laboratories will have a clearer picture of the true number of dengue cases. Dengue is now a reportable disease in the United States, and the availability of state-of-the-art dengue diagnostics will improve patient management and the public health response to dengue."


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