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Emergency use authorization for Zika IgM test

April 24, 2017DiaSorin has received FDA emergency use authorization for the Liaison XL Zika Capture IgM assay, a fully automated serology assay for the detection of Zika virus infections.

“Leveraging over 40 years of infectious disease immunoassay product development and commercialization, we were able to develop a first-of-its-kind assay for Zika virus IgM detection,” John Walter, president of DiaSorin, said in a statement. “Using the proven Liaison XL platform along with an innovative assay format, utilizing the Zika NS1 antigen, DiaSorin was able to produce an assay that yields results in as little as 37 minutes after the specimen is placed on the platform.”

The Liaison XL Zika Capture IgM assay is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human sera collected from individuals meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria. Specimens used with the Liaison XL Zika Capture IgM Assay should be collected between eight days and 10 weeks after onset of symptoms or risk of exposure. The assay is intended for use in laboratories in the United States that are certified to perform high or moderate complexity tests, or by similarly qualified non-U.S. laboratories, consistent with the latest CDC testing algorithms for the diagnosis of Zika virus infection.

Funding for the Liaison XL Zika Capture IgM assay was provided by the U.S. Department of Health and Human Services, which granted DiaSorin a $2.6 million contract in the fall of 2016. The project is funded in whole or in part with federal funds from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, and the Biomedical Advanced Research and Development Authority.

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