NEW YORK (GenomeWeb) – The US Food and Drug Administration recently granted Emergency Use Authorization to DiaSorin's test for detecting the Zika virus.
The EUA was granted to DiaSorin's Liaison XL Zika Capture IgM assay for the presumptive qualitative detection of Zika virus in individuals meeting the Centers for Disease Control and Prevention's Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria. The in vitro diagnostic test is an automated immunoassay that leverages chemiluminescence detection technology to detect Zika virus IgM antibodies in human sera and other authorized specimen types.
Specimens used with the assay should be collected between eight days and 10 weeks after symptoms first appear or the risk of exposure, the FDA said.
The EUA is the second granted by the FDA this month for a Zika assay. The agency granted authorization to Nanobiosym for the Gene-Radar Zika virus test last week. That test detects Zika RNA in human serum meeting the Centers for Disease Control and Prevention's Zika virus clinical and/or epidemiological criteria.