The U.S. Food and Drug Administration May 23 authorized marketing of a diagnostic test for detecting Zika virus antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA is the first Zika diagnostic test the 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—were authorized only for emergency use. The ZIKV Detect 2.0 IgM Capture ELISA – for use only in patients with clinical signs and symptoms consistent with Zika virus infection, and/or who meet the Centers for Disease Control and Prevention’s Zika virus epidemiological criteria – is designed to identify antibodies produced by the body's immune system in the blood. IgM antibodies indicate an early immune response. 

Related News Articles

Headline
The Senate last night voted 85-7 to pass an $857 billion spending package, which includes bills that would fund the departments of Health and Human Services,…
Headline
About 14% of babies age one or older who were born in U.S. territories to pregnant women infected with Zika virus since 2016 have at least one health problem…
Headline
The Food and Drug Administration has issued final guidance revising its recommendations for testing donated whole blood and blood components for Zika virus.
Headline
Illnesses from mosquito, tick and flea bites more than tripled in the United States between 2004 and 2016 to more than 96,000 a year.
Headline
Birth defects associated with Zika virus infection during pregnancy increased 21% in the last half of 2016 in Puerto Rico and portions of Florida and Texas…
Headline
The Centers for Disease Control and Prevention last week issued