NEW YORK (360Dx) – InBios International said Tuesday that the US Food and Drug Administration has granted 510(k) clearance for its DENV Detect NS1 ELISA, an antigen detection assay that provides a presumptive diagnosis of dengue virus before IgM antibodies are present in a patient.
The test is performed on serum samples taken from patients within the first seven days of their presenting with clinical symptoms that are consistent with either dengue fever or dengue hemorrhagic fever.
Dengue is transmitted through the bite of an infected Aedes aegypti mosquito, which is also responsible for transmission of other flaviviruses such as West Nile, chikungunya, and Zika virus.
According to World Health Organization estimates, between 50 and 100 million dengue infections occur annually in more than 100 endemic countries.
InBios said that in prospectively collected archived clinical specimens, its NS1 kit correctly identified 86.6 percent of patients with specimens confirmed positive for dengue NS1 antigen and 97.8 percent of patients with specimens confirmed negative.
The NS1 antigen detection kit is useful in helping differentiate dengue from other flaviviruses that may cross react with dengue antibodies but not with the antigen, InBios said.
InBios Chief Scientific Officer Syamal Raychaudhuri said in a statement that with this latest clearance and product release, InBios offers "a full suite of FDA cleared assays for presumptive diagnosis of both acute and convalescent stages of dengue fever.”
The firm also manufactures an FDA cleared IgM antibody detection ELISA kit, the DENV Detect IgM Capture ELISA, that detects antibodies that appear later than the NS1 antigen.
In December 2016, InBios announced that it had received 510(k) clearance for an antibody-based test that detects Chagas disease.