INTENDED USE
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.

TEST PROCEDURE
Bring tests, specimens, and/or controls to room temperature (10-30°C) before use.

- Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results the assay should be performed within one hour.
- SPECIMEN PREPARATION:
- ASSAY PROCEDURE:Tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. Leave the tube alone for 2 minutes; Remove the small lid at the top; Hold the bottle in a vertical position over the sample well of the test card, deliver 3 drops (about 90μl) of diluted stool sample to the sample well (S) and start the timer.
- Wait for the colored band(s) to appear. Read the result between 5-10 minutes. A strong positive sample may show result earlier. Do not interpret the result after 10 minutes. As the test begins to work, color will migrate across the result area in the center of the device.
INTERPRETATION OF RESULTS
-Positive: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
-Negative: Only one colored band appears, in the control region (C).No apparent colored band appears in the test region (T).
-Invalid: No control line (C) appears
PERFORMANCE CHARACTERISTICS
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%)
COMPANY PROFILE
Hangzhou lmmuno Biotech Co., Ltd is the original organization in lmmuno Group, which has engaged in this industry for more than 10 years. The team of Hangzhou lmmuno Biotech has developed a series of proteins and rapid test kits for the in vitro diagnostic industry in early stage.In the past few years we focused on the human medical diagnostic field which mainly cover the following directions: rapid tests for vector-borne diseases(VBDs), rapid tests for sexually transmitted diseases (STDs), rapid tests for respiratory system diseases, rapid tests for digestive system diseases and rapid test for drug of abuse. For now, we are paying more attention to the diagnosis of neglected tropical diseases (NTDs). With strong R&D ability we are capable to develop and produce test kits for customers in a short time, and our product quality is ahead of similar products in the market.

