Diagnostic Norovirus Antigen Rapid Test Cassette 5-15mins For Stool Feces Sample

Norovirus Antigen Rapid Diagnostic Test Cassette Stool Feces Sample

This Norovirus Antigen Rapid Test kit is used for qualitative detection of norovirus antigen (GI) and Norovirus antigen (GII) in human stool.

For professional use only.

For in vitro diagnostic use only.

INTRODUCTION

Norovirus (NoV), also known as norovirus, belongs to the calciviruses family and is mainly transmitted through contaminated water, food, contact or aerosols formed by pollutants. It has been recognized by European and American countries as the primary pathogen causing viral diarrhea and gastroenteritis in adults, and the second pathogen causing viral diarrhea in children, second only to rotavirus. Norovirus plays an important role in the outbreak of non-bacterial gastroenteritis, which is associated with 30% to 50% of the aseptic gastroenteritis, and 90% of the viral gastroenteritis caused by food is caused by norovirus ". Norovirus is mainly divided into 5 genomes (GI, GII, GIII, GIV and GV), mainly infecting people are GI, GII and GIV, among which norovirus of GII genome is the most common virus strain worldwide 5.6. Clinical or laboratory diagnosis of norovirus infection mainly includes electron microscopy, molecular biology and immunological detection methods. This kit AIDS in the diagnosis of acute viral gastroenteritis, for the rapid diagnosis of the disease to determine the pathogen in time, avoid hospitals or hospitals

PRINCIPLE

This kit is coated with goat anti-mouse IgG polyclonal antibody (C) on nitrocellulose membrane using colloidal gold immunochromatography Line), mouse anti-norovirus monoclonal antibody (GII-2) and mouse anti-norovirus monoclonal antibody (GI-2): Colloidal gold labeled mouse anti-norovirus monoclonal antibody (GII-1) and mouse anti-norovirus monoclonal antibody (G1-1) were fixed on gold label pad. When a positive sample is tested, the norovirus antigen (GII) and/or Norovirus antigen (GI) in the sample combine with the mouse anti-norovirus monoclonal antibody (GII-1) and/or mouse anti-norovirus monoclonal antibody (GI-1) on the gold pad to form a complex that is moved along the membrane by chromatography. After passing the test line, it forms a sandwich complex with the pre-coated antibody to coagulate and develop color, and combines with goat anti-mouse IgG polyclonal antibody at the quality control line to develop color, while negative samples only develop color at the quality control line.

MAIN CONTENTS

• Rapid Test.
• Specimens dilution tube with buffer
• Disposable pipettes
• Instruction for use.

PRECAUTIONS

• For professional in vitro diagnostic use only. Do not use after expiration date.
• Do not eat, drink or smoke in the area where the specimens or kits are handled.
• Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing and follow the standard procedures for proper disposal of specimens.
• Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are being tested.
• Humidity and temperature can adversely affect results.
• The used test should be discarded according to local regulations.

SRORAGE

Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C).

The test is stable through the expiration date printed on the sealed pouch.

The test must remain in the sealed pouch until use.

DO NOT FREEZE.

Do not use beyond the expiration date.

SAMPLE COLLECTION AND STORAGE

Collect stool specimens as soon as possible after symptom onset. If not detected immediately, they can be stored at 2-8 ℃ for 2 days. Long-term storage needs to be frozen at -20℃, which can be stored for 3 years. Aseptic operation should be paid attention to in the collection and storage process of the preserved species, and they should be thawed thoroughly before use and returned to room temperature for testing. When repeated freezing and thawing samples are required, the amount of freezing and thawing shall not exceed 3 times.

OPERATION

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.

1. Add 0.5ml diluent in test tube.

2. Add proper amount of stool sample (about 50mg for solid and 50mL for liquid) into the test tube, so that the concentration is about 5-10%.

3. Mix well.

4. Take 2~3 drops of mixed samples (about 80pL) with an eyedropper and add them to the adding place at the lower end of the indicator arrow of the detection bar for 5~15 minutes for interpretation. The interpretation is invalid after 15 minutes.

INTERPRETATION

QUALITY CONTROL

• Internal procedural controls are included in the test. A colored band appearing in the control region (C) is considered an internal positive procedural control, confirming sufficient specimen volume and correct procedural technique.
• External controls are not supplied with this kit. It is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

PERFORMANCE CHARACTERISTICS

1. It can meet the enterprise standard when verifying with enterprise reference products. P1-P3 was GI positive, P4-P6 was GII positive, P7-P10 was both GI and GII positive; Coincidence rate of negative reference materials: 10 corporate reference materials were negative for Norovirus antigen (GI) and GII; Precision: precision corporate reference product (n=10) is both positive for Norovirus antigen (GI) and norovirus antigen (GII), and has the lowest detection limit for both chromaticity: Minimum detection limit for serial dilution corporate reference product (GI and GII are both positive), and the positive end point should not be less than 1:8 dilution.

2. Staphylococcus aureus (≤4.0x109cfu /mL), diarrheagenic EScherichia coli (≤3.2× 108cfu /mL), Salmonella enteritis (≤2.8x109 cfu /mL), astrovirus (S/C value < 12.32), rotavirus (S/C value≤10.86), adenovirus (≤2.1x1010pfu /mL), Zharu Disease (≤3.0x106pfu /mL), Coxsackie B virus IgM antibody (S/C value ≤10.75), echovirus IgM antibody (S/C value ≤ 10.45), EV71 IgM antibody (S/C value ≤10.48) will not affect the test results of this kit.

3. Containing anaerobic bacteria (≤2.5x108cfu /mL), Enterococcus (≤4.5x108 cfu /mL), Aerobacillus (≤3.9x108 cfu /mL), bifidobacteria (≤3.3x108 cfu /mL), blood (RBC≤7.0x1012/L), leukocyte (WBC ≤12.0x109/L), mucus (mucin ≤ 1.00g/L) will not affect the test results of the kit.

4.HOOK effect: high concentration of strong positive samples can be detected clinically, and the results are not negative; After strong positive samples were diluted, the positive NoV antigen was attenuated and no HOOK effect was observed.

Pelase contact Dewei person for detailed information.