FDA permits marketing of Zika diagnostic test


A Zika virus test initially authorized only for emergency use has now been approved for use in nonemergency situations, according to a statement from the Food and Drug Administration.

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The ZIKV Detect 2.0 IgM Capture ELISA (enzyme-linked immunosorbent assay) is now authorized for use in patients with clinical signs and symptoms consistent with Zika virus infection, as well as those who meet the Centers for Disease Control and Prevention epidemiologic criteria, including residence in or travel to a region deemed high risk because of active Zika transmission.

The test is designed to identify Zika antibodies in the blood, and the FDA cited a review of clinical trial data and analytic data to support the test’s safety and effectiveness.

“Results of this test are intended to be used in conjunction with clinical observations, patient history, epidemiological information, and other laboratory evidence to make patient management decisions,” the FDA stated.

The ZIKV Detect 2.0 IgM Capture ELISA, initially approved in 2016, had been authorized by the FDA only for emergency use, along with other tests for detecting Zika virus, under the under the FDA’s Emergency Use Authorization (EUA) authority.

The FDA granted marketing authorization to test manufacturer InBios International.

The FDA is communicating with four EUA holders to gather information to evaluate whether the FDA should revoke the EUAs for these specific tests. The marketing authorization of ZIKV Detect 2.0 IgM Capture ELISA does not impact the availability of the other 14 Zika nucleic acid diagnostics available under EUAs.

The Zika virus, typically transmitted by an infected mosquito, is especially a risk for pregnant women as the fetus may experience neurologic complications and microcephaly as a result of infection.

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