FDA approves test for dengue virus infection

By Helen Albert

The first test that can detect the presence of the dengue virus itself rather than antibodies to the virus has been approved for use by the US Food and Drug Administration (FDA).

The test, known as the DENV-1-4 Real Time reverse transcription polymerase chain reaction (RT PCR) Assay, was developed by the Centers for Disease Control and Prevention (CDC) in the USA, and can be carried out using equipment and supplies that are currently used by many laboratories to diagnose influenza.

This approval follows last year's approval by the FDA of the first antibody-based diagnostic test for dengue virus - the DENV Detect immunoglobulin (Ig)-M Capture enzyme-linked immunosorbent assay (ELISA) test.

While this test is useful, the IgM antibody response to dengue is only detectable 3-5 days after the onset of fever, which means that a person infected with dengue can produce a negative result if tested too early.

"The need for the new dengue diagnostic test was high," commented Jorge Munoz-Jordan (CDC Dengue Branch, Fort Collins, Colorado) in a press statement.

"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."

The new test detects the presence of all four serotypes of the dengue virus within the first 7 days of dengue-like fever symptoms (acute phase of illness).

The CDC guidelines for the new test suggest that if the DENV-1-4 Real Time RT PCR Assay is negative at 1-5 days of fever then physicians should consider using the DENV Detect IgM Capture ELISA test to confirm their findings.

They also caution that if a patient is tested for the first time after experiencing dengue-like fever symptoms for 7 days or more then the DENV-1-4 Real Time RT PCR Assay is likely to produce a negative result regardless of their infection status.

The CDC emphasizes that, although there is no current vaccine or approved medical treatment for dengue, early treatment can significantly reduce the risk for death for patients infected with the virus. They hope that the new test will enable the earliest possible identification and treatment for many patients with dengue.

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