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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.

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Oct
09
Sponsored by
PerkinElmer

As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.