Viracor-IBT gets FDA emergency use authorisation of Zika Virus Real-time RT-PCR assay

21 July 2016 (Last Updated July 21st, 2016 18:30)

Eurofins Scientific’s subsidiary Viracor-IBT Laboratories (Viracor-IBT) has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Zika Virus Real-time RT-PCR assay.

Eurofins Scientific’s subsidiary Viracor-IBT Laboratories (Viracor-IBT) has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Zika Virus Real-time RT-PCR assay.

Viracor-IBT’s patented molecular Zika virus test is a real-time RT-PCR assay designed to detect the RNA from the Zika virus in human serum, plasma, or urine derived from individuals meeting Zika virus clinical and epidemiological criteria.

The epidemiological criteria considers staying or travelling in a place with a history of Zika outbreak or other epidemiologic criteria for which Zika virus testing may be indicated.

The Zika virus test incorporates sensitivity in its operation as it differentiates between the targeted virus and other members of the Flaviviridae family known to exhibit similar symptoms as that of Zika virus.

Eurofin CEO Dr Gilles Martin said: “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 authorised our assay.

“Viracor-IBT’s Zika test provides timely, accurate results and more testing options to doctors and patients.”

The Zika virus is carried by Aedes mosquitoes which cause symptoms such as mild fever, skin rash, conjunctivitis, muscle and joint pain, malaise or headache which last for two to seven days.

"Viracor-IBT’s Zika test provides timely, accurate results and more testing options to doctors and patients."

Infection of a pregnant woman can cause the fetus to develop microcephaly, which is an abnormal smallness of the head causing incomplete brain development.

According to the Centers for Disease Control and Prevention (CDC), the Zika virus can be detected by carrying out real-time reverse transcription-polymerase chain reaction (RT-PCR) on serum in the first week when a person starts displaying Zika virus disease symptoms.

Urine samples collected less than 14 days from Zika Virus infected patients are recommended for RT-PCR testing, when collected with a patient-matched serum or plasma specimen.


Image: Scans displaying normal-sized skull and microcephaly. Photo: courtesy of Ayacop / PLOS.