FDA OKs marketing of first Zika virus antibodies Dx

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The FDA reviewed data from a clinical study of 807 test samples and a variety of analytical studies, which demonstrated that the ZIKV Detect 2.0 IgM Capture ELISA was safe and effective at identifying IgM antibodies against Zika virus in blood. In samples from patients collected seven days or later after onset of symptoms, the InBios Zika kit correctly identified greater than 90 percent of patients confirmed positive for Zika IgM and greater than 96 percent of patients confirmed negative.

This test is not authorized by the FDA for testing blood or plasma donors.

InBios, 206-344-5821