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 is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing recombinant antigen conjugated with colloid gold (monoclonal mouse anti-Norovirus GI and GII antibody conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing test band (T bands) and a control band (C band). The T band is pre-coated with monoclonal mouse anti-Norovirus GI and GII antibody for the detection of Norovirus GI and GII antigen, 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. Norovirus if present in the specimen will bind to the monoclonal mouse anti-Norovirus GI and GII antibody conjugates. The immunocomplex is then captured on the membrane by the pre-coated mouse anti-Norovirus GI and GII antibody, forming a burgundy colored T band, indicating a Norovirus antigen positive test result.

Absence of test band (T) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the test bands. Otherwise, the test result is invalid, and the specimen must be retested with another device.