InBios has announced that it received an Emergency Use Authorization (EUA) from the 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-US 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.
Wendy Bagnato, Senior Marketing Manager of InBios said, "One of the challenges with developing a serology kit for Zika is the likelihood of cross reactivity with other flaviviruses such as dengue. This can be a particular problem for patients living in or returning from areas where both Zika and dengue (or other flaviviruses) are endemic, making it difficult to determine the status of the patient. InBios’ kit has been designed to differentiate between the possibility of Zika virus and other flaviviruses, thus providing an important diagnostic tool for clinicians."
Bagnato continued, "We are very pleased to be able to offer this high quality kit in time to fill the critical demand in the US and its territories. We are acutely aware of the devastating effect this disease is having on pregnant women and believe this test will aid clinicians to diagnosis Zika virus infection faster."
