INTENDED USE

The Rotavirus and Norovirus Antigen Rapid Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of Rotavirus and Norovirus in human Fecal Specimen. It is suitable for the auxiliary diagnosis of Rotavirus and Norovirus infection.

SUMMARY

Diarrhea is one of the principle causes of childhood morbidity and mortality worldwide, resulting in 2.5 million deaths annually. Rotavirus infection is the leading cause of severe diarrhea in infants and children under the age of five, accounting for 40%-60% of acute gastroenteritis and causing an estimated 500,000 childhood deaths each year. By the age of five, nearly every child in the world has been infected with rotavirus at least once. With subsequent infections, a broad, heterotypic antibody response is elicited; therefore, adults are rarely affected.
To date seven groups of rotaviruses (groups A-G) have been isolated and characterized. Group A rotavirus, the most common rotavirus, causes more than 90% of all Rotavirus infections in humans. Rotavirus is transmitted primarily by the fecal-oral route, directly from person to person. Virus titers in stool reach a maximum shortly after the onset of illness, then decline. The incubation period of a rotavirus infection is usually one to three days and it is followed by gastroenteritis with an average duration of three to seven days. Symptoms of the disease range from mild, watery diarrhea to severe diarrhea with fever and vomiting.
Diagnosis of an infection with rotavirus can be made following diagnosis of gastroenteritis as the cause of severe diarrhea in children. Recently, specific diagnosis of an infection with rotavirus has become available through the detection of virus antigen in stool by immunoassay methods such as latex agglutination assay, EIA, and lateral flow chromatographic immunoassay.
Norovirus are the leading cause of epidemic gastroenteritis,including foodborne outbreak,in the united states. Noroviruses belong to the family Caliciviridae and can be grouped into five genogroups(GI through GV),which are further divided into at least 34 genotyoes. Genotypes GI,GII and GIV infect humans,causing gastroenteritis,whereas GIII and GV typically infect animals.
The symptoms of Norovirus related diseases are those typical of gastroenteritis,that is,vomiting,watery diarrhea and abdominal cramps. Vomiting is a characteristic symptom in the majority of Norovirus infections(64% of adults and 81% od children). Other symptoms such as general malaise,low grade fever,nausea and fatigue are also present in over 90%of cases.The incubation period of the disease is generally between 12 and 48 hours,while infection lasts between 12 and 60 hours.Infection may also be asymptomatic,and thus contribute to the spread of the virus in the community.As a rule,the disease does not have serious consequences,and most patients recover within 1-2 days without complications. Debilitated patients and persons with weaker immune system such as children,elderly or chronic patients may be affected by more serious forms of disease. Specially,dehydration may represent a serious complication for children,the elderly and persons with a precarious metabolic balance or cardio circulatory instability.

PRINCIPLE

The Rotavirus and Norovirus Antigen Rapid Test Kit is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing mouse anti-Rotavirus antibody, mouse anti-Norovirus GI antibody and mouse anti-Norovirus GII antibody conjugated with colloid gold and rabbit IgG-gold conjugates,2) a nitrocellulose membrane strip containing three test bands (T1, T2 and T3 bands) and a control band (C band). The T1 band is coated with antibody for the Rotavirus,T2 band is coated with antibody for the Norovirus GII, T3 band is coated with antibody for the Norovirus GI,and the C band is pre-coated with goat anti rabbit IgG.When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette.