Norovirus Antigen Rapid Test

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.

MATERIALS

Materials Provided

Materials Required but Not provided

TEST PROCEDURE

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

1. 1. 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.
2. 2. SPECIMEN PREPARATION:

Unscrew the cap of the specimen collection tube, then randomly stab the sampling rod into the stool specimen in at least 3 different sites to collect approximately of feces (equivalent to 1/4 of a pea). Hold the Specimen collection tubes with extraction buffer vertically, insert the sampling rod, squeeze the bottom of the tube. Mix stool specimen with the buffer thoroughly by shaking the bottle for a few seconds.

1. 3. 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.

Note: Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

As the test begins to work, color will migrate across the result area in the center of the device.

• 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 (+) :
  1. NorovirusGI 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. NorovirusGI 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. NorovirusGII 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). A negative result indicates no norovirus infection.
  • Invalid:No purple red band in quality control area (C). Indicates incorrect operation or deterioration of the test. In this case, read the instructions carefully again and retest with a new test. If the problem persists, you should immediately stop using the batch number and contact your local supplier.

  • LIMITATIONS OF THE TEST

    1. 1. The NorovirusAntigen Rapid Test is for professional in vitro diagnostic use, and should only be used for the qualitative detection of human Norovirus.
    2. 2. The test result should be used only to evaluate with patient With signs and symptoms of the disease. A definitive clinical diagnosis should only be made by the physician after all clinical and laboratory finding have been evaluated.
    3. 3. As with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (HAMA) in the specimen. Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain HAMA. Such specimens may cause false positive or false negative results.

    4. As all diagnostic tests, a confirmed diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.