The COVID-19 antigen saliva test kit is an in vitro immunoassay that detects SARS-CoV-2 variant alpha, beta, gamma, kappa, and delta. The antigen saliva test kit is for the direct and qualitative detection of SARS-CoV-2 viral nucleoprotein antigens from human saliva samples collected from individuals suspected of having COVID-19 within the first 7 days of symptom onset. The COVID-19 antigen saliva test kit is intended for use by laypersons and enables self-testing at home. The test identifies SARS-CoV-2 viral nucleoprotein antigen. The antigen is generally detectable in saliva samples during the acute phase of infection.
COVID-19 Antigen Test Procedure
1. Twist off the cap of the buffer bottle, carefully dispense all buffer into the extraction tube。
2. After collecting the mouth sample with the swab, insert the swab into the extraction tube, and plunge the swab up and down in the fluid for a minimum of 10 seconds. Hold the swab against the bottom of the tube, and rotate three turns. DO NOT splash liquid out of the tube.
3. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.
4. Press the nozzle cap firmly onto the extraction tube. Mix thoroughly by swirling or flicking the bottom of the tube.
5. Gently squeeze the tube’s rigid body, and dispense two (2) drops of the buffer-specimen mixture into the sample well on the coronavirus antigen test cassette.
6. Read the test results between 15 and 20 minutes. Do not read the results after 20 minutes.
Interpretation of Test Results
NEGATIVE: A colored band appears on the control line (C line); no colored band shows up on the test line (T line). A negative result indicates there is no coronavirus antigen (N protein) in the specimen, or the level of coronavirus antigen is below the detection limit.
POSITIVE: A colored band appears on the control line (C line), and a second colored band shows up on the test line (T line). A positive result indicates the presence of COVID-19 antigen (N protein) in the patient sample.
INVALID: No colored band appears on the control line (C line). An invalid test result suggests there might be insufficient buffer volume or incorrect operating procedures. Carefully review the test procedure and test the same patient again with another coronavirus antigen rapid test cassette.