FDA Awards Ninth EUA for Zika Dx

The FDA granted an Emergency Use Authorization for InBios International's Zika diagnostic to confirm the presence of Zika virus antibodies.

The ZIKV Detect IgM Capture ELISA detects Zika virus IgM antibodies in human sera collected from individuals with clinical signs and symptoms associated with Zika virus infection.

Confirmation of the presence of anti-Zika IgM antibodies or other flavivirus IgM antibodies requires additional testing. — Tamra Sami