1. Product Description:
COVID-19 Antigen Rapid Test Cassette is for in vitro qualitative detection of specific antigens to SARS-CoV-2 present in human saliva. It cannot be used as the basis for the diagnosis and exclusion of COVID-19.
2. Intended Use:
This reagent is used to detect cases with suspected symptoms of COVID-19 within 7 days. If suspected symptoms are more than 7 days, it is recommended to test with COVID-19 antibodies or nucleic acid reagents.
The main clinical symptoms of COVID-19 are: Fever, dry cough, fatigue, a few patients will have stuffy noses, runny nose,s, and diarrhea.
HOW TO PERFORM THE TEST?
1. Remove a Test Device from the foil pouch by tearing at the notch and place it on a level surface.
2. Holding Extraction Reagent bottle vertically, add 10 drops (400μL) to the Extraction tube.
3. Insert the nasopharyngeal (and oropharyngeal) swab sample(s) into the extraction solution, then, mix the swab 10 times.
4. Remove the swabs while pressing against the solution tube in order to extract most of the specimen
5. Place the dropper cap and drop 3 drops (60~70μl) into the sample well.
6. Read the result in 10-15 minutes. Do not read results after more than 20 minutes.
Prior to testing, all reagents were returned to room temperature.Testing shall be performed at room temperature.
I. Sample extraction (see Figure 1)
1. Add 400 L (about 10 drops) of sample buffer vertically to the sample extraction tube and then insert the sample into the tube and rotate against the inner wall about 10 times so that the samples in the solution dissolve as much as possible.
2. Squsample q-tip along the inner wall of the extraction tube to retain as much liquid in the tube as possible from the sample, then removed and discarded.
3. Cover the dropper.
two.Test procedure (see Figure 2)
1. Remove the test card from the sealing bag.
2. Add 2 drops (about 80 L) of the treated sample extract to the sample hole of the test card and start the timer.
3. The results were read after placing the test card for 15 minutes at room temperature.The results were invalid after 20 minutes.
Schematic diagram of the test card result judgment:
Invalid ① result: the quality control line (C line) has no reaction line, the detection is invalid, and the test shall be repeated.
② negative result: red ribbon, quality control line (C line) is in color.
③ positive result: two red bands, detection line (T line) and quality control line (C line) are in color.