FDA permits marketing of first test for most common cause of gastroenteritis outbreaks

The U.S. Food and Drug Administration allowed marketing of the first test for the preliminary identification of norovirus.

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.

Norovirus is a leading cause of food-borne disease outbreaks in the United States.

Acute gastroenteritis is an inflammation of the stomach and intestine that can cause diarrhea, vomiting and stomach pain. Norovirus contamination usually occurs in settings where there is close group contact, such as cruise ships, hospitals, long-term care facilities, and schools or child-care centers. It is a highly contagious virus that spreads rapidly through direct person-to-person contact, contaminated food or water, and by touching contaminated surfaces.

“This test provides an avenue for early identification of norovirus,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Early intervention can halt the spread of an outbreak.”

The test is not sensitive enough for use when only a single person has symptoms and should not be used for diagnosing individual patients.

The manufacturer demonstrated the performance of the Ridascreen test by comparing results of it to the results of a norovirus reference standard for 609 fecal samples. When the fecal samples were tested with Ridascreen, overall results on average were less sensitive than those of standard reference tests, detecting norovirus across samples about 2/3 of the time it was present.

The FDA reviewed data for Ridascreen via the de novo pathway, an alternative path to market for devices that are lower risk and may not require premarket approval (PMA), but are of a new type, and therefore may not be able to be cleared in a '510(k)' premarket notification.

In March, the U.S. Centers for Disease Control and Prevention will be updating management and disease prevention guidelines for norovirus outbreaks. These guidelines will likely reflect substantial advances made in norovirus epidemiology, immunology, diagnostic methods and infection control.

Ridascreen is made by R-Biopharm AG, located in Darmstadt, Germany.

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FDA, CDC, and States Investigating Norovirus Illnesses Linked to Oysters

The U.S. Food and Drug Administration is advising consumers to avoid eating oysters harvested from the San Antonio Bay on or after Nov. 16 due to reports of norovirus-associated illnesses in some people who had consumed oysters harvested from this area, which is located on the Gulf of Texas.

The FDA, along with the Centers for Disease Control and Prevention (CDC) and the states of North Carolina, South Carolina and Texas, are investigating about a dozen reports of norovirus-related illnesses from South Carolina and North Carolina consumers who ate oysters recently harvested from the San Antonio Bay.

Consumers who purchased oysters on or after Nov. 16 that have a label showing they came from San Antonio Bay are advised to dispose of the oysters and not eat them. At restaurants, consumers can ask about the source of oysters offered as menu items. Restaurant operators and retailers should not serve or offer for sale oysters subject to this advisory. Restaurant operators and retailers who are unsure of the source of oysters on hand should check with their suppliers to determine where the oysters were harvested. No other seafood is affected by this advisory.

The Texas Department of State Health Services has ordered a recall of all oysters harvested from the San Antonio Bay between Nov. 16 and Nov. 25.

Noroviruses are a group of viruses that cause gastroenteritis. Symptoms of illness associated with norovirus include nausea, vomiting, diarrhea and stomach cramping. Affected individuals often experience low-grade fever, chills, headache, muscle aches and a general sense of tiredness. Most people show symptoms within 48 hours of exposure to the virus. The illness typically lasts one to two days. Norovirus typically is not life-threatening and does not generally cause long-term effects.

Consumers who ate oyster products on or after Nov.16 and have experienced symptoms of norovirus are encouraged to contact their health care provider and local health department.

The implicated oyster beds in the San Antonio Bay were closed by the Texas Department of Health Services on Nov. 26, 2009, and remain closed.

The FDA and CDC will continue working with health officials in the affected states to track any additional cases of norovirus illness.

Persons with weakened immune systems, including those affected by AIDS, and persons with chronic alcohol abuse, liver, stomach or blood disorders, cancer, diabetes or kidney disease should avoid raw oyster consumption altogether, regardless of where the oysters are harvested.

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