Cassette

Product Name:
One Step Rotavirus & Adenovirus Antigen Test 
Accessories:
Instruction for use, feces collection tube
Principle of Test:
Immunochromatographic assay
Product Performance
Rotavirus: Specificity : 99.4%, Sensitivity: 98.4%

Adenovirus:Specificity : 99.2%, Sensitivity: 97.5%

 INTENDED USE

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 gastro-enteritis, especially in children less than 2 years old. Its discovery in 1973 and its association with infantile gastro-enteritis represented a very important advance in the study of gastro-enteritis not caused by acute bacterial infection. Rotavirus is transmitted by oral-faecal contact with an incubation period of 1-3 days etc. In the case of hospitalised 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 gastro-enteritis in children (10-15%). This virus may also cause respiratory diseases and, depending on the serotype, also diarrhoea, conjunctivitis, cystitis,etc. At least 47 serotypes of RV/ADV have been described, all sharing a common hexon antigen.Serotypes 40 and 41 are the ones associated with gastro-enteritis, whose main symptom is diarrhoea thatmay last between 9 and 12 days associated with temperature and vomits.

 

TEST PROCEDURE

1. Bring the pouched test device to room temperature (15-30℃) prior to testing. 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. Please see “SPECIMEN COLLECTION AND STORAGE”.

4. Shake the sample collection tube well.

5. Holding the sample collection tube upright, carefully unscrew the top cap of collection tube.

6. Squeeze 2 drops of the specimen solution in the sample well.

7. Read results between 5-10 minutes. Do not read the result after 10 minutes.

  

 

INTERPRETATION OF RESULTS

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 having been detected.Three distinct red lines appear,this indicates positive test result and RV and ADV antigens having been detected.

Negative: Only one red line appears in the control region(C). This indicates a negative test results 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, please contact your local distributor.