RAPID ADENO-ROTA VIRUS ANTIGEN COMBO TEST

Immunochromatographic rapid assay for the Detection of Adenovirus and Rotavirus Antigens in Human Stool Specimens

INTENDED USE:

Rapid Adeno/Rota Combo Test is an in vitro qualitative immunochromatographic assay for the rapid detection of adenovirus rotavirus antigens in human stool specimen. The test results are intended to aid in the diagnosis of rotavirus infection and to monitor the effectiveness of therapeutic treatment.

SPECIFICATION:

1)        Specimen: feces

2)        Format: panel

FEATURE:

1)        Simple: simply add specimen and dilution(if necessary) into sample well

2)        Rapid: results come out at 5-10 minutes

3)        Visually interpreted: don’t need any equipment

4)        Stable: more than 12 month period of validity

PACKING:

Cassette: 25 tests/box, 50 tests/box

PROCEDURE:

1)        Bring all materials and specimens to room temperature   (8 – 30^oC).

2)        Remove the test card from the sealed foil pouch.

3)        Hold the sample bottle upright with the tip point toward  the direction away from the test performer, snap off the tip.

4)        Hold the bottle in a vertical position over the sample well of the test card, deliver 3 drops ( 120 -150 μL ) of diluted stool sample to the sample well.

5)       Read the result between 5 - 10 minutes. A strong positive sample may show result earlier.

Note: Results after 10 minutes may not be accurate.

PRINCIPLE:

Rapid Adeno/Rota Combo Test is a sandwich solid phase immunochromatographic assay. To perform the test, an aliquot of diluted stool sample is added to the sample well of the test cassette. The sample flows through a pad containing antibodies against adenovirus and rotavirus coupled to red-colored colloidal gold. If the sample contains adenovirus or rotavirus antigens, the antigen will bind to the antibody coated on the colloidal gold particles to form antigen-antibody-gold complexes. These complexes move on the nitrocellulose membrane by capillary action toward the test line region on which adenovirus and rotavirus specific antibodies are immobilized separately. As the complexes reach the test line, they will bind to the antibody corresponding to the virus on the membrane to form of a line. A red control line will always appear in the result window to indicate that the test has been correctly performed and the test device functions properly. If virus is not present or lower than the detection limit of the test, only the control line will be visible. If the control line dose not developed, the test is invalid.