COVID-19 Antigen Test Cassette(Swab) is a rapid chromatographic immunoassay for the qualitative detection of COVID-19 antigen in nasal swab specimen to aid in the diagnosis of COVID-19 viral infection.
Material Provided
1.Test Devices
2.Extraction Buffer
3.Extraction Tube
4.Sterilized Swab
5.Work Station
6.Package Insert
Specimen Collection
1. Oropharyngeal Swab Sample:
Let the patient's head tilt slightly, mouth open, and make "ah" sounds, exposing the pharyngeal tonsils on both sides. Hold the swab and gently wipe both sides of the patient's pharyngeal tonsils back and forth at least three times.
2. Nasopharyngeal Swab Sample:
Let the patient's head relax naturally, carefully insert the swab in the patient’s nostril. Swab over the surface of the posterior nasopharynx and rotate the swab several times.Use the same swab, take specimens from the other nostril in the same way.
After Swab specimens were collected, swab can be stored in extraction reagent provided with the kit. Also can be stored by immersing the swab head in a tube containing 2 to 3 mL of virus preservation solution (or isotonic saline solution, tissue culture solution, or phosphate buffer).
Freshly collected specimens should be processed as soon as possible, but no later than one hour after specimen collection. Specimen collected may be stored at 2-8℃ for no more than 24 hours; Store at -70 ℃ for a long time, but avoid repeated freeze-thaw cycles.
Specimen Preparation
1. Take out the extraction tube, add 8 drops (about 0.3 mL) of the extraction reagent into the extraction tube, and put it on the tube rack.
2. Put the swab specimen into the extraction tube, rotate the swab for about 10 seconds, and press the swab head against the tube wall to release the antigen in the swab.
3. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab. so as to remove as much liquid as possible from the swab. Dispose of swabs according to biohazard waste disposal method.
4. Insert a dropper tip into the extraction tube tightly.
Read the instructions carefully before use and allow test device, extraction reagent and specimens to equilibrate to room temperature prior to testing.
1. Open the package and take out the test device.
2. Hold the extraction tube vertically and add two drops of the test specimens into the specimen well (s). Start the timer.
3. Interpret the results within 20 minutes. Strong positive results can be reported within 20 minutes, however, negative results must be read after 20 minutes, and the results after 30 minutes are no longer valid.
Interpretation of Test Results
Negative result: if there is only a quality control line C, the detection line T is colorless, indicating that SARS-CoV-2 antigen has not been detected and the result is negative.
Positive result: if both the quality control line C and the detection line T appear, indicating that SARS-CoV-2 antigen has been detected and the result is positive.
Invalid result: if the quality control line C is not observed, it will be invalid regardless of whether there is detection line T (as shown in the figure below), and the test shall be conducted again.