Rapid Test for Respiratory Virus RSV and Norovirus Antigens Detection

Norovirus Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Genegroup 1 and Genegroup 2 noroviruses antigens in human stool specimen. The test results are intended to aid in the diagnosis of Norovirus infection for children and adults with the symptoms of suspected gastroenteritis caused by the Norovirus. 

Norovirus Antigen Rapid Test  HNV029G

SUMMARY

This kit is used for qualitative detection of norovirus antigen (GI) and norovirus antigen (GII) in human faeces in vitro.Norovirus (NoV), also known as Norovirus, belongs to the calicidae family.The particles were 20-hedral symmetric in shape with a diameter of 27-35nm and without capsula. Norovirus is one of the main pathogens causing non-bacterial acute gastroenteritis at present. This virus is highly infectious.mainly transmitted through contaminated water, food and other ways,contact transmission or aerosol formed by pollutants. It is the secondpathogen that causes viral diarrhea in children after rotavirus, and it breaksout collectively in crowded places. Norovirus is mainly divided into fivegenomes (GI, GII, GII, GIV and GV), which mainly infect people with GI, GIIand GIV, among which the norovirus of GII genome is the most commonvirus strain worldwide.

MATERIALS

PRINCIPLE

Using the principle of colloidal gold immunochromatography, this kit is coated with goat anti-mouse IgG polyclonal antibody (C-line), mouse anti-norovirus monoclonal antibody (GI-2), and mouse anti-norovirusmonoclonal antibody (GII-2) on a nitrate cellulose membrane in sequence.Mouse monoclonal antibody against norovirus (GI-1) and mouse monoclonaantibody against norovirus (GII-1) labeled with colloidal gold were both fixedon the gold plate. When a positive sample is tested, the norovirus antigen (GI)and/or norovirus antigen (GII) in the sample combine with the mouse monoclonal antibody against norovirus (GI-1) and/or mouse monoclonal antibody against norovirus (GII-1) on the gold pad to form a complex that ismoved along the membrane by chromatography. After the test line, it forms sandwich complex with the pre-coated antibody to coagulate for color development, and binds with goat anti-mouse IgG polyclonal antibody at thequality control line for color development, and negative samplesColor display only at the quality control line.

Relative Sensitivity: 93.55% (95%CI: 88.46%～96.86%)

Relative Specificity: 99.25% (95%CI: 97.33%～99.91%)

Accuracy: 97.16% (95%CI: 95.10%～98.53%)

Positive (+):1. Norovirus GI and Norovirus GII Positive: Three purple red bands appear. One is located in the detection area (T1), one is located in the detection area (T2), the other is located in the quality control area (C).

2.Norovirus GI Positive: Two purple red bands appear. One is located in the detection area (T1), the other is located in the quality control area (C).

3.Norovirus GII Positive: Two purple red bands appear. One is located in the detection area (T2) and the other is located in the quality control area(C). A positive result indicates norovirus infection.Note: The purple red band in the detection area (T1/T2) can show the phenomenon of dark and light color. However, during the specified observation time, regardless of the color of the band, even very weak band should be interpreted as a positive result.

Negative (-) : Only a purple red band appears in the quality control area(C). No purple red bands were found in the detection area (T1 or T2). Anegative result indicates no norovirus infection.

Invalid: No purple red band in quality control area (C) Indicatesincorrect operation or deterioration of the test. In this case, read theinstructions carefully again and retest with a new test. If the problempersists, you should immediately stop using the batch number andcontact your local supplier.