The FDA has authorized marketing of the ZIKV Detect 2.0 IgM Capture ELISA to detect Zika virus immunoglobulin (IgM) antibodies in human blood.
This is great news for those trying to fight this illness, which can lead to severe brain damage to newborns whose mothers contracted the disease, which is often hard to diagnose.
The ZIKV Detect 2.0 IgM Capture ELISA is the first Zika diagnostic test FDA has allowed to be marketed in the U.S.; 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.
Read the release here:
https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-diagnostic-test-detecting-zika-virus-antibodies?utm_campaign=20190529%20MCMi&utm_medium=email&utm_source=Eloqua
May 2019