Zika ELITe MGB® Kit U.S. and ELITe InGenius, the fully automated sample-to-result system, has joined the fight against the Zika virus.
In December, ELITechGroup received Emergency Use Authorizat
ion (EUA) from the U.S. Food and Drug Administration (FDA) for the Zika ELITe MGB Kit U.S. used in combination with ELITe InGenius.
Zika ELITe MGB Kit U.S. used in combination with ELITe InGenius, is an easier and faster molecular solution for ZIKA testing in comparison to other EUA assays issues from the FDA.
Using ELITechGroup Molecular Diagnostics proprietary industry-leading MGB technology, this high-performance real-time PCR assay targets a highly conserved region of Zika virus.
ELITe InGenius integrates all the steps of Zika virus detection: from sample preparation, to results analysis including PCR set-up, reverse transcription, and real-time PCR amplification.
The full automation of the ELITe InGenius system optimizes the Zika testing workflow and reduces hands-on time to few minutes. Up to 12 reactions are performed in less than 3 hours. “This Emergency Use Authorization demonstrates our commitment to become an IVD solution provider in molecular diagnostics, leveraging on the ELITe InGenius system and the MGB technology, and is also a step forward in our expansion strategy into the U.S. market,” said ELITechGroup CEO Christoph Gauer.
For more information about Zika ELITe MGB Kit U.S., ELITe InGenius and other ELITechGroup solutions, visit the ELITechGroup website.
The Zika ELITe MGB Kit U.S. is for use only under Emergency Use Authorization (EUA) in CLIA-certified High Complexity Laboratories in the United States. The Zika ELITe MGB Kit U.S. has not been FDA cleared or approved. It is only authorized for use for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection.”
