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DiaSorin Zika Assay Cleared by FDA

NEW YORK – The US Food and Drug Administration announced it has cleared DiaSorin's Liaison XL Zika Capture IgM Assay II for detecting Zika virus IgM antibodies.

DiaSorin's test had previously only been authorized for emergency use by the FDA. As a result of the marketing clearance, the Emergency Use Authorization granted in 2017 has been revoked.

The in vitro diagnostic test, an automated immunoassay leveraging chemiluminescence detection technology, can be used for the presumptive qualitative detection of the Zika virus IgM antibodies in human sera collected from individuals meeting the US Centers for Disease Control and Prevention's Zika virus clinical or epidemiological criteria.

Earlier this year, the FDA cleared two other tests for detecting Zika virus antibodies, the InBios ZIKV Detect 2.0 IgM Capture ELISA test and Siemens Healthineers' Advia Centaur Zika test.