Zika Test Receives FDA Authorisation
News Jul 21, 2016
Viracor-IBT Laboratories, Inc., a subsidiary of Eurofins, has announced that it received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Zika Virus Real-time RT-PCR assay. Viracor-IBT will perform this assay under CLIA/CAP regulations for High Complexity Clinical Laboratories. The assay has been approved by the New York State Department of Health (NYSDOH). The proprietary molecular Zika virus test is a real-time RT-PCR assay intended for the qualitative detection of RNA from Zika virus in human serum, plasma, or urine (collected alongside a patient-matched serum or plasma specimen) collected from individuals meeting Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated).
Viracor-IBT’s Zika Virus Real-time RT-PCR has excellent sensitivity and does not cross-react with other viruses in the Flaviviridae family (including dengue virus, Japanese encephalitis virus, West Nile virus and St. Louis encephalitis virus) or with other viruses known to cause similar clinical symptoms such as chikungunya virus. According to 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 real-time reverse transcription-polymerase chain reaction (RT-PCR) on serum. Additionally, 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.
Dr. Gilles Martin, Eurofins’ CEO 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’s Zika test provides timely, accurate results and more testing options to doctors and patients.”
Zika virus is primarily spread through mosquitos and can also be spread by some forms of sexual contact. Zika virus has been linked to microcephaly in newborns and is at the forefront of concern for emerging infectious diseases. The Zika virus outbreak in South America has potential to further reach North America with the onset of the mosquito season, and Viracor-IBT will be prepared to assist patients by providing a fast turnaround time (within 8-12 hours of specimen receipt) on test results.
“Viracor-IBT has a proven history of developing and validating highly sensitive, accurate assays in response to emerging public health needs, like Zika virus. In 2009, Viracor-IBT was one of the first laboratories to market with the H1N1 Influenza A RT-PCR assay. We are committed to developing high quality infectious disease assays that help our clients help more patients,” said Steve Kleiboeker, PhD, HCLD/TS/CC (ABB), Vice President of Research and Development, Viracor-IBT.
Viracor-IBT’s PCR assay development goes above and beyond “traditional” real-time PCR and RT-PCR design in that redundancy is present in the assay to account for the full range of viral serotypes, genotypes or isolates that may be infecting patients. With this expert approach to assay design, a problematic viral genomic polymorphism on one target will not result in inaccurate quantification or false positive results. Like all other EUA authorizations, the Zika Virus Real-time RT-PCR test has not been FDA cleared or approved and 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.