On Aug. 19, 2016, InBios announced that it had received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its ZIKV Detect™ IgM Capture ELISA. The product is intended for the presumptive detection of Zika virus IgM antibodies in human sera collected from individuals meeting CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria. This important diagnostic test kit contains all the necessary reagents to perform this assay and obtain results in four hours or less. Additional testing is required to confirm positive results from this assay.

The ZIKV Detect™ IgM Capture ELISA is not cleared or approved by the FDA. It is now available for use in laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories, as a part of a multi-test CDC recommended testing algorithm. As one of the conditions of authorization outlined by FDA, InBios will report any suspected false negative results of which it becomes aware to the FDA.

This test has been authorized only for the diagnosis of Zika virus infection and not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.