FDA Clears First Zika Blood Test for Routine Use

Megan Brooks

May 23, 2019

The US Food and Drug Administration (FDA) has cleared the ZIKV Detect 2.0 IgM Capture ELISA (InBios International Inc) for routine use in detecting Zika virus immunoglobulin (IgM) antibodies in human blood.

This the first diagnostic test for Zika the FDA has allowed to be marketed in the US. Previously, tests for detecting Zika virus IgM antibodies — including the ZIKV Detect 2.0 IgM Capture ELISA — had been authorized only for emergency use under the FDA's emergency use authorization (EUA) authority.

"At the onset of the Zika virus outbreak, when little was known about the disease or how to diagnose it, the FDA worked quickly with manufacturers to encourage the development of diagnostic tests and ensure they were available using our emergency use authorities," FDA Acting Commissioner Ned Sharpless, MD, explains in a news release.

"[This] marketing authorization is a great demonstration of the FDA's work to protect the public health in emergency response situations. We ensured there were tests made available quickly under EUA, but we continued to work with diagnostic manufacturers to take the next step of ensuring products were FDA reviewed for safety and effectiveness and authorized under our traditional premarket authorities," he notes.

The Zika virus is spread to people primarily through the bite of an infected Aedes species mosquito. Zika virus infection has been linked to neurologic complications (eg, Guillain-Barré Syndrome), as well as microcephaly and other poor outcomes associated with Zika virus infection during pregnancy, increasing the importance of having diagnostic tests available, the FDA says.

The FDA reviewed data from a clinical study of 807 test samples and a variety of analytical studies, which showed that the ZIKV Detect 2.0 IgM Capture ELISA was safe and effective at identifying IgM antibodies against Zika virus in blood.

The test should only be used in patients with clinical signs and symptoms consistent with Zika virus infection, and/or who meet Centers for Disease Control and Prevention (CDC) Zika virus epidemiologic criteria, such as history of residence in, or travel to, a geographic region with active Zika transmission at the time of travel.

Results of the test should be used in conjunction with clinical observations, patient history, epidemiologic information and other laboratory evidence to make patient management decisions, the FDA advised.  Negative results may be seen in specimens collected before day 4 after the onset of symptoms or after the window of detectable IgM closes, and therefore do not preclude the possibility of Zika virus infection, past or present, the agency notes. This test should not be used to test blood or plasma donors for Zika.

The ZIKV Detect 2.0 IgM Capture ELISA was reviewed through the de novo premarket pathway, a regulatory pathway for some low- to moderate-risk devices of a new type. Along with this marketing authorization, the FDA is establishing "special controls" designed to provide a "reasonable assurance of safety and effectiveness for tests of this type," the agency said.

This approval does not impact the availability of the 14 other Zika nucleic acid diagnostics available under EUAs, the FDA said.

Although there were some cases of local Zika mosquito-borne virus transmission in the continental US in 2016, the CDC reports that no new cases were reported in 2018 or thus far in 2019.

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