Product Specification

Rapid Test for Detection of Norovirus antigen(Colloidal Gold)

Name and Intended Use

Bioneovan Norovirus Antigen Rapid Detection Kit (Colloidal Gold) is an in vitro immunoassay method for the one-step qualitative determination of norovirus in human fecal specimens. As an auxiliary diagnosis for acute viral gastroenteritis, it can quickly diagnose disease pathogens, avoid hospital or community transmission, and reduce unnecessary antibiotic treatment.

Summary

Norovirus (NoV), also known as Norovirus, belongs to the Caliciviridae family. It is primarily transmitted through contaminated water, food, etc., via contact with pollutants or aerosol transmission. Recognized as the primary pathogen causing viral diarrhea and gastroenteritis in adults in Europe and the United States, Norovirus is the second most common pathogen responsible for viral diarrhea in children, following rotavirus. In outbreaks of non-bacterial gastroenteritis, Norovirus holds a significant position, with 30% to 50% of aseptic gastroenteritis cases being associated with it, and 90% of foodborne viral gastroenteritis being caused by the virus [4]. Norovirus is mainly classified into five genogroups (GI, GII, GIII, GIV, and GV). The primary infections are attributed to GI, GII, and GIV. Among them, the GII genogroup of Norovirus is the most prevalent strain globally. Clinical or laboratory diagnosis of Norovirus infection involves three methods, including electron microscopy, molecular biology, and immunological detection.

Principle of the Assay

The reagent kit utilizes the principle of colloidal gold immunochromatography. Goat anti-mouse IgG antibody (line C), mouse monoclonal antibody against Norovirus (GII-2), and mouse monoclonal antibody against Norovirus (GI-2) are successively coated on a nitrocellulose membrane. Mouse anti-Norovirus antibody (GII-1) and mouse monoclonal antibody against Norovirus (GI-1) are simultaneously fixed on the gold standard pad. When a positive sample is detected, the Norovirus antigen (GII) and/or Norovirus antigen (GI) in the sample bind to the mouse anti-Norovirus antibody (GII-1) and/or mouse monoclonal antibody against Norovirus (GI-1) on the gold pad to form a complex, which migrates along the membrane under chromatography. The sandwich complex is formed with the pre-coated antibody at the detection line, and coloration occurs by binding with the goat anti-mouse IgG antibody at the quality control line. Negative samples only show coloration at the quality control line.

Materials Provided

20 tests Norovirus rapid test Cassette

Each box contains as below:

1. Test card: 20 tests

2. Sample dilution: 1ml /bottle × 20

3. Instruction manual: 1 piece

The components in different batches and different varieties of kits may not be mixed.

Sample Collection and Preservation

Samples collected should be tested within a three-month timeframe and stored at -20°C. If preservation exceeds three months, they should be stored at -70°C. Transportation, if necessary, must be conducted under low temperature conditions. Aseptic procedures should be followed during both collection and storage of fecal samples. Thaw thoroughly before use and allow them to return to room temperature prior to testing.

Test Procedure

If the kit is kept in the refrigerator, return the kit to room temperature before use.

1. Unscrew the cap, remove the picking screw, take the sample from the feces (about 100mg), place it in the picker with the sample diluent, and tighten the cap.

2. Shake and mix, and screw the top cap of the toilet.

3. Place the test card on a flat surface, vertically and slowly add 2-3 drops of the mixed sample (about 80 μl) to the center of the test card loading end.

5-15 minutes of interpretation. After 15 minutes, the interpretation is invalid.

Precautions

1. This kit is exclusively intended for in vitro diagnostic purposes.
2. Once opened, store the kit in a dry environment and endeavor to use it within 9 weeks. Do not mix components from different batches.
3. While the product itself does not present biosafety risks, handle tested reagents and samples as infectious substances.
4. Overly abundant or excessively thick stool samples may lead to sample dilution issues, potentially obstructing test strips. Prioritize collecting the supernatant after allowing the sample to stand or centrifuge.
5. Avoid adding an excessive volume of sample to the test strip, as it may yield erroneous results.

Storage and Stability

Sealed at 4-30 ° C in the dark & dry condition.

Certificate:

CE approval

Product Pictures