Allow the test, specimen, extraction buffer to equilibrate to room temperature (15-30°C) prior to testing.
1. Remove the test device from the sealed foil pouch and use it as soon as possible.
Place the test device on a clean and level surface. Best results will be obtained if the assay is performed immediately after opening the foil pouch.
2. Take out one extraction tube with buffer, pull off the sealed aluminum foil on the extraction tube and place extraction tube in the tube stand or in the hole in the box.
3. Place the sterilized swab specimen in the sample extraction buffer. Rotate the swab for approximately 10 seconds while pressing the head against the inside of the tube to release the antigen in the swab.
4. Remove the sterilized swab while squeezing the sterilized swab head against the inside of Buffer as you remove it to expel as much liquid as possible from the swab. Discard the sterilized swab in accordance with your biohazard waste disposal protocol.
5. Screw on and tighten the Nozzle with Filter onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the sample extraction buffer. See illustration 4.
6. Add 3 drops of the solution (approx.80ul) to each sample well and then start the timer. Read the result at 15~20 minutes. Don’t interpret the result after 20 minutes.
7. Please dispose the test materials which put in a closed plastic bag with the household trash. If there are local regulations, please follow them. 8. Wash hands thoroughly after test completion
POSITIVE SARS-Cov-2: Two red lines appear. One red line appears in the control region(C), and one red line in the test region(T).
POSITIVE Influenza A: Two distinct colored lines appear. One colored line should be in the control region (C) and another colored line should be in the Influenza A region (A). A positive result in the Influenza A region indicates that Influenza A antigen was detected in the sample.
POSITIVE Influenza B: Two distinct colored lines appear. One colored line should be in the control region (C) and another colored line should be in the Influenza B region (B). A positive result in the Influenza B region indicates that Influenza B antigen was detected in the sample.
POSITIVE Influenza A and Influenza B: Three distinct colored lines appear. One colored line should be in the control region (C) and two colored line should be in the Influenza A region (A) and Influenza B region (B). A positive result in the Influenza A region and Influenza B region indicates that Influenza A antigen and Influenza B antigen were detected in the sample.
*NOTE: The shade of color may vary, but it should be considered positive whenever there is even a faint line.
If the test result is positive, please keep social distant to not spread infection, to follow local guidelines about social distance.
NEGATIVE: Only one red line appears in the control region(C), and no line in the test region(T/A/B). If you have symptoms like fever, cough and/or shortness of breath. Please retest in 1-3 days. You must continue following the applicable hygiene and distancing rules even with a negative result.
INVALID: No red line appears in the control region(C). The test is invalid even if there is a line on test region(T/A/B). Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the test procedure and repeat the test using a new test device.
Certifications
2022 MEDICA in Germany
Date: from November 14th to November 17th
Add.: Messe Düsseldorf
Hall: 01
Out booth No: 1H39
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