Dengue Assay Kit gets approved by FDA

Dengue is usually transmitted by the mosquito Aedes aegypti, and rarely by Aedes albopictus. Dengue is currently endemic in more than 110 countries.
It causes high grade fever, headache, severe body pain, rashes and sometimes bleeding from various places in its severest form.
It is therefore, called as Break-bone fever or Dengue haemorrhagic fever. There is no approved vaccine or definite treatment. Treatment is symptomatic and supportive only.
Antibody to it appears after 4-5days of infection and so a diagnostic blood test using the antibody within that period may be negative.
Definitive diagnosis now rests on cell culture and viral isolation

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Dengue Fever Assay Gets FDA Marketing Nod

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 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 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.





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