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Viracor-IBT gets FDA EUA status for Zika Virus RT-PCR assay

MDBR Staff Writer Published 21 July 2016

Eurofins Scientific subsidiary Viracor-IBT Laboratories has received emergency use authorization (EUA) status from the US Food and Drug Administration (FDA) for its Zika Virus real-time reverse transcription-polymerase chain reaction (RT-PCR) assay.

Approved by the New York State Department of Health (NYSDOH), the assay will be performed under CLIA/CAP regulations for high complexity clinical laboratories. 

Viracor-IBT’s Zika virus assay will be used for the qualitative detection of RNA from Zika virus in human serum, plasma or urine collected from individuals meeting Zika virus clinical criteria and epidemiological criteria.

The assay does not cross-react with other viruses in the Flaviviridae family, comprising of dengue virus, Japanese encephalitis virus, West Nile virus and St. Louis encephalitis virus.

As per the Centers for Disease Control and Prevention (CDC), during the first week after onset of symptoms, Zika virus disease can often be diagnosed by performing RT-PCR on serum.

In addition, urine samples collected less than 14 days after onset of symptoms are recommended for RT-PCR testing, when collected alongside a patient-matched serum or plasma specimen.

Eurofins Scientific CEO Gilles Martin said: "As a leader and trusted laboratory partner specialized in and dedicated to improving patient care through innovative infectious disease testing, Viracor-IBT is thrilled to be one of the first commercial laboratories to offer the Zika RT-PCR test to hospitals and health systems, and we are pleased that the FDA recently authorized our assay. 

Viracor-IBT research and development vice president Steve Kleiboeker said: "Viracor-IBT has a proven history of developing and validating highly sensitive, accurate assays in response to emerging public health needs, like Zika virus.”