One-Step Rotavirus (RV) & Adenovirus (ADV) Antigen Test

Instructions for use 

Feces collection tube

Immunochromatographic assay

The RV/ADV Antigen Test Device is a sandwich lateral flow chromatographic immunoassay for the qualitative detection of RV/ADV antigen in feces.

Rotavirus (RV) is the primary causative agent of acute gastroenteritis, especially in children under 2 years old. Its discovery in 1973 and its association with infantile gastroenteritis represented a significant advance in the study of gastroenteritis not caused by acute bacterial infection. Rotavirus is transmitted by oral-fecal contact with an incubation period of 1-3 days etc. In the case of hospitalized children with acute enteritis, up to 50% of the samples examined are rotavirus positive.

The RV/ADV (ADV) is the second most common cause of viral gastroenteritis in children (10-15%). This virus may also cause respiratory diseases and, depending on the serotype, also diarrhea, conjunctivitis, cystitis, etc. At least 47 serotypes of RV/ADV have been described, all sharing a common hexon antigen. Serotypes 40 and 41 are associated with gastroenteritis, whose primary symptom is diarrhea that may last between 9 and 12 days and is associated with temperature and vomits.

Test Procedure:

1. Before testing, bring the pouched test device to room temperature (15-30℃). Do not open the pouch until ready to perform the assay.
2. Remove the test device from the sealed pouch. Lay it on a flat, clean, and dry surface.
3. Specimen collection.
4. Shake the sample collection tube well.
5. Holding the sample collection tube upright, carefully unscrew the top cap of the collection tube.
6. Squeeze two (2) drops of the specimen solution in the sample well.
7. Read the result between 5-10 minutes. Do not read the result after 10 minutes.

• Positive: Two distinct red lines appear, one in the test region T1 or T2 and another one in the control region(C). This indicates a positive test result, and RV or ADV antigens have been detected. Three distinct red lines indicate a positive test result, and RV and ADV antigens have been detected.
• Negative: Only one red line appears in the control region(C). This indicates a negative test result and no RV/ADV antigens having been detected.
• Invalid: If the control line fails to appear, the test result is invalid regardless of the presence or absence of the test line. (NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, contact your local distributor.)