INTENDED USE

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

SUMMARY

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 Norovirus Antigen Rapid Test Kit Norovirus GI + GII test is a qualitative lateral flow immunoassay for the detection of norovirus GI and GII antigens in human faeces samples. Antibodies against norovirus GI and GII antigens are pre-coated in the test line region of the membrane. During testing, the sample reacts with particles coated with antibodies against noroviruses GI and GII which are pre-dried on the test strip. The mixture migrates along the membrane by capillary action. In the case of a positive result specific antibodies present on the membrane react with the mixture of conjugates and generate one or two red coloured lines. A green coloured line should always appear in the control line region and serves as verification that sufficient volume of sample has been added, that membrane wicking has occured and as an internal control for reagents.