On Sept. 11, 2018, the U.S. Food and Drug Administration (FDA) had announced that it had received 510k marketing clearance from the FDA for its DENV Detect NS1 ELISA. This antigen detection assay provides presumptive diagnosis of dengue virus from serum samples taken from patients within the first seven days of clinical symptoms consistent with either dengue fever or dengue hemorrhagic fever, before IgM antibodies are present.

The InBios NS1 assay is highly sensitive and specific. In prospectively collected archived clinical specimens, the NS1 kit correctly identified 86.6% of patients confirmed positive for dengue NS1 antigen and 97.8% of negative confirmed patient specimens.