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Principle

The RSV Ag Rapid Test device (Swab) detects RSV antigens through visual interpretation of color development on the strip. RSV antibodies are immobilized on the test region of the membrane respectively. During testing, the extracted specimen reacts with anti- RSV antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient RSV antigens in the specimen, colored band will form at the according test region of the membrane. The presence of a colored band in the test region indicates a positive result for the particular viral antigens, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

Directions For Use

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 Strip with patient or control identification. For best results, the assay should be performed within one hour.
2. Gently mix Extraction reagent solution.
For bottle buffer: Add 5 drops (about 200ul) of the Extraction Solution into the Extraction tube.
For single buffer: transfer all buffer (about 200ul) into the extraction tube.
3. Place the patient swab specimen into the Extraction Tube. Roll the swab at least 10 times while pressing the swab against the bottom and side of the Extraction Tube. Roll the swab head against the inside of the Extraction Tube as you remove it. Try to release as much liquid as possible. Dispose of the used swab in accordance with your biohazard waste disposal protocol.
4. Put the strip into the extraction test tube and then start the timer.
5. As the test begins to work, color will migrate across the membrane. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.