The US Food and Drug Administration (FDA) has authorized marketing of ZIKV Detect 2.0 IgM Capture ELISA, a diagnostic test to detect Zika virus immunoglobulin (IgM) antibodies in human blood.
The FDA has authorized InBios International to market the ZIKV Detect 2.0 IgM Capture ELISA to market in the US. The diagnostic test is the first Zika diagnostic testFDA has allowed to be marketed in the US.
FDA said that in the past, it authorized the ZIKV Detect 2.0 IgM Capture ELISA, only for emergency use under the its Emergency Use Authorization (EUA) authority.
FDA acting commissioner Ned Sharpless said: “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.
“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.”
The Zika virus is primarily spread through the bite of an infected Aedes species mosquito, while people infected with Zika virus infection mostly experience no symptoms.Yet, the virus is capable ofposing serious public health risks.
Zika virus infection is linked with neurological complications including Guillain-Barré Syndrome along with microcephaly and other complications during pregnancy.The adverse outcomes associated with Zika virus infection have increased the importance of diagnostic tests for Zika virus.
The ZIKV Detect 2.0 IgM Capture ELISA identifies the antibodies/proteins produced by the body’s immune system when exposed to the Zika virus infection for the tests and production of IgM antibodies is considered an early immune response.
The FDA said that it has reviewed data from a clinical study involving 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.