FDA Okays First Dengue Fever Test
The FDA has cleared the first test to diagnose patients with signs and symptoms of dengue fever.
The test, known as the DENV Detect IgM Capture ELISA, looks for dengue virus antibodies in blood samples of patients who are symptomatic for the fever.
There are no tests currently cleared or approved by the FDA for direct detection of dengue virus.
The new test's clearance was made possible through an alternate marketing path known as the de novo pathway, which allows for marketing of new devices that are low to moderate risk in use and that may not require premarket approval, an FDA statement said.
The test should not be used on patients who are asymptomatic, the statement said.
The agency warned that test results can be complicated by the IgM antibody response to dengue virus, which doesn't occur until three to five days after the fever's onset, meaning that the test may show a negative result despite infection.
The test may also react to related viruses -- such as that responsible for West Nile disease -- but in U.S. testing results, patients that showed signs of dengue should be considered to show presumptive evidence of dengue, according to the agency.
The test is made by Inbios, of Seattle.
April 15, 2011