The U.S. Food and Drug Administration has cleared ZIKV Detect 2.0 IgM Capture ELISA for detecting Zika virus immunoglobulin (IgM) antibodies in human blood.
This is the first diagnostic test for Zika the FDA has allowed to be marketed in the US., reports FDA. Previously, diagnostic 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,” said Ned Sharpless, MD, FDA Acting Commissioner in the press 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 said.
The Zika virus is spread primarily through the bite of an infected Aedes species mosquito. While many people with Zika virus infection experience no symptoms, the virus can pose potentially serious risks to the public health.
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 relevance of having diagnostic tests available.
The ZIKV Detect 2.0 IgM Capture ELISA is designed to identify proteins (antibodies) produced by the body’s immune system when it tests for Zika virus infection in the blood. IgM antibodies indicate an early immune response.
The FDA reviewed data from a clinical study of 807 test samples and a variety of analytical studies, which demonstrated that the ZIKV Detect 2.0 IgM Capture ELISA was safe and effective at identifying IgM antibodies against Zika virus in blood.
The ZIKV Detect 2.0 IgM Capture ELISA is for use only in patients with clinical signs and symptoms consistent with Zika virus infection, and/or who meet the CDC’s Zika virus epidemiological criteria, such as history of residence in or travel to a geographic region with active Zika transmission at the time of travel, says FDA.
Results of this test are intended to be used along with clinical observations, patient history, epidemiological information and other laboratory evidence to make patient management decisions. Negative results may be seen in specimens collected before day four 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 test is not authorized by the FDA for testing blood or plasma donors.
The FDA granted marketing authorization of the ZIKV Detect 2.0 IgM Capture ELISA to InBios International, Inc.