FDA authorizes marketing of first Zika diagnostic

June 11, 2019

For the first time, the US Food and Drug Administration (FDA) has authorized marketing of a test to detect Zika virus immunoglobulin (IgM) antibodies in the bloodstream.

For the first time, the US Food and Drug Administration (FDA) has authorized marketing of a test to detect Zika virus immunoglobulin (IgM) antibodies in the bloodstream. Prior to this approval, Zika virus detection tests, including this one, had only been allowed under the FDA’s Emergency Use Authorization (EUA). 

The ZIKV Detect 2.0 IgM Capture ELISA is designed to identify IgM antibodies produced by the body’s immune system in response to a Zika infection. The FDA reviewed data from a clinical study of 807 test samples and a variety of analytical studies, which demonstrated the safety and effectiveness of the device.  

“[This] marketing authorization is a great demonstration of the FDA’s work to protect the public health in emergency response situations,” said FDA Acting Commissioner Ned Sharpless, MD. “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.” 

The device is for use only in patients with clinical signs and symptoms consistent with Zika virus infection and/or those who meet the epidemiological criteria for Zika risk (history or residence in or travel to a geographic region with active Zika transmission the time of travel). Test results are supposed to be used in conjunction with clinical observations, patient history, epidemiological information, and laboratory results. However, negative results may be seen in specimens collected before Day 4 after onset of symptoms or after the window of IgM closes, so negative results may not preclude the possibility of Zika virus infection, past or present. 

Prior to the marketing authorization for ZIKV Detect 2.0 IgM Capture ELISA, 18 available Zika tests had been approved for use under the EUA. Currently there are 18 active EUAs for Zika tests, four of which operate similarly to the ZIKV Detect 2.0 IgM Capture ELISA.  The FDA is communicating with those test manufacturers to gather information to determine whether these assays should have their EUAs revoked. The EUA for the ZIKV Detect 2.0 IgM Capture ELISA was revoked but the other 14 EUA holders are not impacted by the recent approval.