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FDA Issues EUA for Siemens Zika Test

NEW YORK (360Dx) – The US Food and Drug Administration this week issued an emergency use authorization for Siemens Healthcare Diagnostics' Advia Centaur Zika test.

The EUA was issued for the test for the qualitative detection of Zika virus IgM antibodies in human serum and plasma collected from individuals who meet the Zika virus clinical criteria of the US Centers for Disease Control and Prevention, and/or CDC's Zika virus epidemiological criteria, the FDA said. The authorization also is for the test to be done in CLIA-certified laboratories.

According to the FDA, if the Siemens test indicates an individual may be infected with Zika, additional testing to confirm the presence of anti-Zika IgM antibodies is required.

The agency said that the test is the fourth Zika serological assay available under EUA. Last month, the FDA granted EUA to Zika assays from Thermo Fisher Scientific and Columbia University