FDA approves DENV Detect NS1 Elisa Kit tp detect Dengue virus. InBios
The FDA has granted 510(k) clearance to InBios� DENV Detect NS1 Elisa Kit, used for detection of the dengue virus in patients.The antigen detection assay is used for presumptive clinical laboratory diagnosis of the Dengue virus and has not been cleared for testing blood or plasma donors. The kit uses samples collected from patients within the first week of showing symptoms of dengue fever or dengue hemorrhagic fever to detect the presence of the dengue virus.
The DENV Detect NS1 ELISA is for the early detection of Dengue virus (DENV) NS1 antigen in human serum. This test is for the presumptive clinical laboratory diagnosis of Dengue virus infection. This assay is intended for use in patients with clinical symptoms consistent with either dengue fever or dengue hemorrhagic fever. Samples collected from patients within seven (7) days after the onset of clinical symptoms should be evaluated with this assay (day 0 � day 7). Negative results obtained with this test do not preclude the diagnosis of dengue and should not be used as the sole basis for treatment or other patient management decision.
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