The US Food and Drug Administration (FDA) has permitted marketing of Ridascreen Norovirus 3rd Generation EIA assay, the first test for preliminary identification of norovirus.
The Ridascreen test is indicated for use when a number of people have simultaneously contracted gastroenteritis and there is clear pathway for virus transmission, such as food.
The test is not sensitive enough when only one person has symptoms and should not be used for screening individual patients.
The manufacturer conducted a study, in which the Ridascreen test results where compared to the results of a norovirus reference standard for 609 faecal samples.
The study results showed that Ridascreen test was less sensitive than standard reference tests, and was able to detect norovirus across samples about 2/3 of the time it was present.
The FDA reviewed Ridascreen via the de novo pathway, an alternative path to market for devices that are lower risk and may not require premarket approval (PMA).
Since these products are of new type, they may not be cleared in a 510(k) premarket notification.
Ridascreen is made by Germany-based R-Biopharm.