This rapid test for Detection of Norovirus antigen (Colloidal Gold) is an in vitro immunoassay for the qualitative determination of the detection of Norovirus in human feces specimens in one step and is used as an auxiliary diagnostic reagent for the early diagnosis of acute viral gastroenteritis. It quickly diagnoses the pathogen for a disease.
Norovirus (NoV) belongs to the family Calicivirus. It is mainly transmitted through the contaminated water, food, etc, and is also transmitted by the contact or aerosol formed by pollutants. It has been recognized as the primary pathogen causing viral diarrhea and gastroenteritis in adults in Europe and the United States and is the second pathogen to rotavirus in children with viral diarrhea. In the outbreak of non-bacterial gastroenteritis, Norovirus occupies an important position, 30% to 50% of aseptic gastroenteritis is related to it, and 90% of viral gastroenteritis caused by food is because of this virus. Norovirus is mainly divided into five genomes (GI, GII, GIII, GIV and GV). The main infections are GI, GII and GIV, the Norovirus of GII genome is the most common strain in the world. There are three methods for clinical or laboratory diagnosis of this infection, such as electron microscopy, molecular biology and immunological detection.
PRINCIPLES OF THE ASSAY
This test kit uses a colloidal gold immunochromatography assay, the colloidal gold-labeled goat-anti-mouse IgG is coated on the C-line and mouse anti-Norovirus monoclonal antibody (GII-2) and mouse anti-Norovirus on nitrocellulose membrane. Monoclonal antibody (GI-2); a gold-labeled mouse-anti-norovirus antibody (GII-1) and a mouse anti-Norovirus monoclonal antibody (GI-1) are simultaneously immobilized on a gold standard pad. When a positive sample is detected, the Norovirus antigen (GII) and/or Norovirus antigen (GI) in the sample and the mouse-anti-Norovirus antibody (GII-1) and/or the mouse anti-Norovirus single moves on the gold pad. The cloned antibody (GI-1) binds to form a complex and moves along the membrane by chromatography. At the detection line, a sandwich complex is formed with the pre-coated antibody and color is developed by binding to the goat-anti-mouse IgG antibody at the quality control C-line, and the negative sample is only developed at the quality control line.
20 x1 tests Norovirus Rapid Test Cassette
Each box contains as below:
Test card: 20 tests
Sample diluents: 20 bottle × 1 ml.
Manual: 1 copy
The components in different batches and of different varieties of kits should not be mixed.
The collected samples are tested within 3 months and are stored at -20 °C. If saving for more than 3 months then store at-70 ° C. If transportation is required, it should be carried out at low temperatures. The samples to be preserved should be treated aseptically during the collection and storage. Thoroughly thaw before use and return it to room temperature before testing.
If the test kit is kept in the refrigerator, return it to the room temperature before use.
Unscrew the cap and remove the picking screw, take the sample (about 100mg), place it in the picker with the sample diluents and tighten the cap.
Shake and mix well, and screw the top cap.
Place the test card on a flat surface; vertically and slowly add 2 to 3 drops of the mixed sample (about 80μl) at the center of the test card loading end.
5 to 15 minutes of interpretation and after15 minutes the interpretation is invalid.
INTERPRETATION OF RESULTS
Only C-line color development: negative;
C line, II line color development: Norovirus antigen (GII) positive;
C line, I line color development: Norovirus antigen (GI) positive;
C line, II line, I line color development: Norovirus antigen (GII) and Norovirus antigen (GI) are positive at the same time;
Only R line or A line color development: invalid;
C line, R line, A line is not colored: invalid
Only detect Norovirus antigen (GII) and Norovirus antigen (GI) in the stool samples.
This test kit cannot be used as a quantitative detection reagent.
Any positive results needed to be determined after contacting the clinical information.
All highly sensitive immunoassay systems are inevitably non-specific and may cause biological false positives.
Used for in vitro diagnostic only
After the kit is opened, store it at a dry place and try to use it within 9 weeks. Do not mix the components of different batches;
The product itself will not cause bio-safety problems, but the tested reagents and samples should be treated as infectious substances
Excessive collection of stool samples or thick samples may cause the diluted sample to clog the test strips. Please take the diluted sample after standing or centrifuge to take the supernatant for testing
The sample added to the test strip should not be in large quantity; otherwise it will cause erroneous results.
Storage and stability
Store at 4 to 30 ° C in the dark and dry condition and the shelf life is of 24months. Do not use the kit beyond its expiry date.