FDA Clearance for InBios DENV Detect NS1 ELISA Test for Early Detection of Dengue Fever
InBios has 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. The NS1 antigen detection kit is useful to help differentiate from other flaviviruses that may cross react with dengue antibodies but not with the antigen.
In addition, InBios manufactures an FDA cleared IgM antibody detection ELISA kit (DENV Detect IgM Capture ELISA) which detects antibodies that appear later than NS1. Performing both tests in parallel can detect early or later stage suspected dengue.
Date Published: 9th October 2018
Source article link: InBios International Inc.