Immuno's Rapid SARS CoV-2 Rotavirus Antigen Test

Rotavirus Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human Rotavirus antigen 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. 

Rotavirus Antigen Rapid Test

Principle

Rotavirus Antigen Rapid 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 rotavirus coupled to red-colored colloidal gold. If the sample contains 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 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.

Components

TEST PROCEDURE

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

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. SPECIMEN PREPARATION

Unscrew the sample bottle, use the attached applicator stick attached on the cap to transfer small piece of stool (4-6 mm in diameter; approximately 50 mg – 200 mg) into the Assay Buffer Tube. For liquid or semi-solid stools, add 100 microliters of stool to the vial with an appropriate pipette. Replace the stick in the bottle and tighten securely. Mix stool sample with the buffer thoroughly by shaking the bottle for a few seconds.

3. ASSAY PROCEDURE

3.1 Hold the Assay Buffer Tube upright with the tip point toward the direction away from the test performer, snap off the tip.

3.2. 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 (S) and start the timer.

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.

3.3. 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: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

NOTE:

1. The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

COMPANY INTRODUCTION

Hangzhou Immuno Biotech Co.,Ltd is the original organization in Immuno Group. The team of Hangzhou Immuno Biotech has developed a series of proteins and rapid test kits for the in vitro diagnostic industry in early stage. Gradually, IMMUNO was well known as a good R&D partner and good supplier of veterinary rapid test products. With great patience and continuous investment in design and development of IVD relative reagents and test kits, we got several encouraging achievements in the past year, especially in veterinary diagnostic field.