Influenza A Rapid Test Dipstick (ONLY FOR PROFESSIONAL USE, NOT FOR PUBLIC USE)

【SUMMARY】
The Influenza A Rapid Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A nucleoprotein antigens in nasopharyngeal swab and nasal aspirate samples. The test strip is composed of the following parts: namely sample pad, reagent pad, reaction membrane, and absorbing pad. The reagent pad contains the colloidal-gold conjugated with the monoclonal antibodies against Influenza virus A; the reaction membrane contains the secondary antibodies for virus A, and the polyclonal antibodies against the mouse globulin, which are pre-immobilized on the membrane. The whole

strip is fixed inside a plastic plate. When the sample is added into the sample window, conjugates dried in the reagent pad are solubilized and migrate along with the sample. If influenza A is present in the sample, a complex formed between the anti- influenza A conjugate and the virus will be captured by the specific anti-influenza A monoclonal coated on the Test Region (T). Results appear at 15 minutes in the form of a red line that develops on the membrane.
To serve as a procedural control, a red line will always appear in the control region(C) indicating that proper volume of sample has been added and membrane wicking has occurred.

【DIRECTIONS FOR USE】
Allow the test, specimen, extraction buffer to equilibrate to room temperature (15-30°C) prior to testing.
1. Remove the test dipstick from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed immediately after opening the foil pouch.
2. Place the Extraction Tube in the workstation. Hold the extraction reagent bottle upside down vertically. Squeeze the bottle and let the solution drop into the extraction tube freely without touching the edge of the tube. Add 10 drops of solution (Approx. 400μl) to the Extraction Tube. See illustration 1.
3. Place the swab specimen in the Extraction Tube. Rotate the swab for approximately 10 seconds while pressing the head against the inside of the tube to release the antigen in the swab. See illustration 2.
4. Remove the swab while squeezing the swab head against the inside of the Extraction Tube as you remove it to expel as much liquid as possible from the swab. Discard the swab in accordance with your biohazard waste disposal protocol. See illustration 3.
5. With arrows pointing down, place the dipstick into the tube of solution and then start the timer. If the procedure is followed correctly, the liquid should be below the maximum line (MAX) on the test dipstick. See the illustration 4.
6. Wait for the colored line(s) to appear. Read the result at 15 minutes. Do not interpret the result after 20minutes.