This rotavirus antigen test kit is intended for the direct qualitative detection of the presence of rotavirus antigen in patient fecal samples. The test might be used as an aid for detecting patients with acute gastroenteritis infected with rotavirus. It is for professional use only.

Background:
Rotaviruses are the main cause of acute gastroenteritis and diarrhea, especially in children under the age of two years. Rotaviruses have been identified in almost 40% of the faces of children with gastroenteritis. Rotavirus is the cause of up to 50% of the hospitalized cases of diarrhea in infant and young children. If not treated, the infection may result in severe dehydration and disorders of body electrolyte balance. Therefore, it can be mortal in risk populations such as children, the elderly or immunosuppressed individuals. Rotavirus is transmitted by oral-fecal contact with an incubation period of 1-3 days. Characteristic symptoms include vomiting, hydrodiarrhoea for between 3 and 8 days, high temperature and stomach pains. A large amount of rotavirus particles is shed during infection.
Diagnosis of gastroenteritis with rotavirus infection can be established based on the detection of the virus particles by electron microscopy or the virus antigen by specific immunoassay methods.

For investigational use only. The performance characteristics of this product have not been established.