The ZIKV Detect 2.0 IgM Capture ELISA has been authorized for marketing by the Food and Drug Administration for detection of Zika virus immunoglobulin.
Previously, the product was authorized for emergency use only. After analyzing 807 blood samples, the FDA determined that the product was safe and effective for detecting the Zika virus.
“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 FDA Acting Commissioner Ned Sharpless. “Today's 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.”
Zika infection during pregnancy can cause neurological complications such as Guillian-Barre Syndrome and microcephaly (the abnormal smallness of the head of the baby). There was locally transmitted Zika virus in the United States in 2016 but no reports last year or this year.
The ZIKV Detect 2.0 IgM Capture ELISA must be used in conjunction with other criteria, such as the early onset of symptoms and history of residence or travel to an effected area.
