FDA Clears Test to Detect Norovirus Outbreaks

The first test that can be used for the preliminary identification of norovirus in outbreaks of acute gastroenteritis has been cleared for marketing by the Food and Drug Administration, the agency announced on Feb 23.

The test, 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," according to the FDA statement announcing the approval. The test should not be used to diagnose individual patients, because it is not sensitive enough to be used when a single person has symptoms, the statement added.

In a study that compared the performance of the Ridascreen test with the results of a norovirus reference standard for 609 fecal samples, results with the Ridascreen detected the norovirus in about two-thirds of the cases where it was present, so overall it was less sensitive than was the standard reference test in detecting norovirus. The study was conducted by the test’s manufacturer, R-Biopharm AG, Darmstadt, Germany.

"This test provides an avenue for early identification of norovirus," and early intervention can stop the spread of an outbreak, Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the statement.

Norovirus, the most common cause of acute gastroenteritis in the United States, is highly contagious, spreading rapidly by direct contact with an infected person, ingestion of contaminated food or liquids, or touching contaminated surfaces or objects, according to the Centers for Disease Control and Prevention. The virus can spread rapidly in nursing homes and other closed environments.

The first test that can be used for the preliminary identification of norovirus in outbreaks of acute gastroenteritis has been cleared for marketing by the Food and Drug Administration, the agency announced on Feb 23.

The test, 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," according to the FDA statement announcing the approval. The test should not be used to diagnose individual patients, because it is not sensitive enough to be used when a single person has symptoms, the statement added.

In a study that compared the performance of the Ridascreen test with the results of a norovirus reference standard for 609 fecal samples, results with the Ridascreen detected the norovirus in about two-thirds of the cases where it was present, so overall it was less sensitive than was the standard reference test in detecting norovirus. The study was conducted by the test’s manufacturer, R-Biopharm AG, Darmstadt, Germany.

"This test provides an avenue for early identification of norovirus," and early intervention can stop the spread of an outbreak, Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the statement.

Norovirus, the most common cause of acute gastroenteritis in the United States, is highly contagious, spreading rapidly by direct contact with an infected person, ingestion of contaminated food or liquids, or touching contaminated surfaces or objects, according to the Centers for Disease Control and Prevention. The virus can spread rapidly in nursing homes and other closed environments.

The first test that can be used for the preliminary identification of norovirus in outbreaks of acute gastroenteritis has been cleared for marketing by the Food and Drug Administration, the agency announced on Feb 23.

The test, 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," according to the FDA statement announcing the approval. The test should not be used to diagnose individual patients, because it is not sensitive enough to be used when a single person has symptoms, the statement added.

In a study that compared the performance of the Ridascreen test with the results of a norovirus reference standard for 609 fecal samples, results with the Ridascreen detected the norovirus in about two-thirds of the cases where it was present, so overall it was less sensitive than was the standard reference test in detecting norovirus. The study was conducted by the test’s manufacturer, R-Biopharm AG, Darmstadt, Germany.

"This test provides an avenue for early identification of norovirus," and early intervention can stop the spread of an outbreak, Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the statement.

Norovirus, the most common cause of acute gastroenteritis in the United States, is highly contagious, spreading rapidly by direct contact with an infected person, ingestion of contaminated food or liquids, or touching contaminated surfaces or objects, according to the Centers for Disease Control and Prevention. The virus can spread rapidly in nursing homes and other closed environments.