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FDA approves marketing of first Zika virus antibody test :

May 23, 2019

The first test for Zika virus antibodies was granted the green light to hit the market Thursday.

The ZIKV Detect 2.0 IgM Capture ELISA from InBios International Inc. previously was being used under the Food and Drug Administration’s (FDA’s) Emergency Use Authorization (EUA), but the agency now will allow broad use.

“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,” FDA Acting Commissioner Ned Sharpless, M.D., said in a news release.

Zika is a Flavivirus transmitted primarily by Aedes mosquitoes but also can be spread through sex, blood transfusions and from a mother to her unborn child.

Roughly 80% of infections are believed to be asymptomatic, but Zika can cause microcephaly and other neurologic abnormalities in infants who contract it in utero.

The Zika test approved Thursday is for use in patients with Zika symptoms (fever, rash, joint pain and conjunctivitis) or who have lived in or traveled to an area with active Zika transmission.

Zika spread throughout the Americas in 2015 and 2016, infecting thousands, but has since slowed. No local transmission was reported in the continental U.S. in 2018 or 2019. Last year, there were 72 Zika cases in travelers returning to the continental U.S. and 148 cases in residents of U.S. territories. This year, only one case has been reported in the U.S.

The Centers for Disease Control and Prevention still recommends that pregnant women and couples who may want to become pregnant take precautions if they are traveling to certain areas.

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