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LabCorp launches RealStar Zika virus test in US

MDBR Staff Writer Published 07 June 2016

Laboratory Corporation of America Holdings (LabCorp) has launched the RealStar Zika virus test in the US.

Zika

The test, which was created by altona Diagnostics, secured emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for the qualitative identification of Zika virus RNA in serum or urine.

It will be used to diagnose Zika virus infection in individuals meeting clinical or epidemiological criteria for infection risk established by the Centers for Disease Control and Prevention (CDC).

The test is claimed to be only clinically appropriate in symptomatic individuals during approximately the first seven days after the onset of symptoms.

The serum and urine samples will be tested concurrently for better diagnostic accuracy.

The company intends to provide serological testing for Zika virus when there is an FDA approved for emergency use product available to commercial labs.

Zika virus, which will primarily spread through mosquito bites and sexual contact, was identified in 618 individuals in the US as of 1 June this year.

LabCorp chairman and CEO David King said: "The Zika virus is a serious public health threat, and many people are concerned about the risk it presents to them and their families.

"Offering this new Zika virus test aligns with LabCorp's strategy to deliver world-class diagnostics that provide physicians and patients with information they need to achieve better health outcomes."

LabCorp Diagnostics chief scientific officer Marcia Eisenberg said: "Public health officials anticipate that the U.S. will become an area of active Zika virus transmission this year."


Image: Space-fill drawing of the outside of one Zika virus particle, and a cross-section through another as it interacts with a cell. Photo: courtesy of David Goodwill.