A test that could aid in the early identification of norovirus, a leading cause of foodborne disease outbreaks, has been approved for use in the U.S., the Food and Drug Administration announced Wednesday.
Developed by R-Biopharm AG, a German company, the “Ridascreen Norovirus 3rd Generation EIA” test could be used when a large number of people–for instance, guests at a banquet–have come down with gastroenteritis.
In such a circumstance, quick test results might help to initiate hygiene measures to get ahead of the highly contagious virus. This is the first test FDA has cleared for diagnosis of norovirus infections, and having it available locally may mean more rapid preliminary identification of norovirus as the cause of an outbreak.
“Early intervention can halt the spread of an outbreak,” said Dr. Jeffrey Shuren, J.D., director of FDA’s Center for Devices and Radiological Health, in the agency’s news release.
Although the R-Biopharm AG website says the test is reliable for sporadic cases as well as outbreaks, the FDA said it is not sensitive enough to diagnose individual patients, and should not be used when only one person has symptoms.
To gain approval, the manufacturer demonstrated that the Ridascreen test could detect norovirus across stool samples about 2/3 of the time, good enough for preliminary identification, the FDA decided.
The FDA said it reviewed Ridascreen via the “de novo pathway,” a streamlined, alternative path to win approval for innovative devices that are lower risk and may not require premarket approval (PMA), the regular (and sometimes lengthy) process used to evaluate whether Class III medical devices are safe and effective.
Norovirus, though typically not as severe as illnesses caused by Salmonella or E. coli O157:H7, can make people feel extremely ill with vomiting and diarrhea for one or two days, and they can remain contagious for as many as three days after their symptoms disappear.
Norovirus is the most common cause of acute gastroenteritis in the United States, estimated to be responsible for nearly 60 percent of foodborne illnesses.
It’s also highly contagious. Eating contaminated food or drinking beverages, person-to-person contact, or even touching contaminated surfaces can cause infection, which can spread rapidly. In recent months, 69 people became ill with norovirus at a charity auction in Florida, 37 students fell ill at a University of Michigan sorority house and 150 wedding guests were stricken with norovirus at a reception in Ontario, Canada.
In the U.S., norovirus is not yet a nationally notifiable condition because testing for it has not been generally not available in hospital labs and doctors’ offices.
Next month, the Centers for Disease Control and Prevention will be updating its management and disease prevention guidelines for norovirus outbreaks. The guidelines, according to the FDA news release, will likely “reflect substantial advances made in norovirus epidemiology, immunology, diagnostic methods and infection control.”