The US Food and Drug Administration (FDA) has announced approval of what it calls the first test for preliminary identification of norovirus, intended for use in outbreaks in which there is a likely transmission pathway.
The test, called the Ridascreen Norovirus 3rd Generation EIA assay, “is for use when a number of people have simultaneously contracted gastroenteritis and there is a clear avenue for virus transmission, such as a shared location or food,” the FDA said in a news release yesterday. The test is made by R-Biopharm AG of Darmstadt, Germany.
“This test provides an avenue for early identification of norovirus. Early intervention can halt the spread of an outbreak,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. The agency did not say how long the test takes to give a result.
The test is not sensitive enough for diagnosing norovirus infection in individual patients, the FDA said.