Description
Solid phase immunochromatographic assay for the rapid and qualitative detection of 2019-nCoV antigen in the human nasal cavity.
This test only provides a preliminary result for the self-test. Therefore, any reactive samples must be confirmed with alternative test methods and clinical results.
The test uses COVID-19 antibody (test line T) and goat anti-topoIgG antibody (control line C) immobilized on a nitrocellulose strip. The bordeaux-colored conjugated pad contains colloidal gold.
When the treated buffer containing the sample is added to the sample well, it combines with the COVID-19 antibody conjugate to form an antigen-antibody complex. This complex migrates through the capillary action nitrocellulose membrane.
When the complex meets the COVID-19 antibody line of the T test line, the complex is trapped forming a burgundy colored line confirming a reactive test result.
The absence of a colored line in the test region indicates a non-reactive test result.
The test contains an internal control (band C) which should show a burgundy color band of the immune complex regardless of color development on any test band. If not, the test result is invalid and the sample must be retested with another device.

How to use
Sample collection
The test can be performed using nasal swab samples.
The test should be performed immediately after sample collection.
Bring samples to room temperature prior to testing.

Remove secretions on the surface of the anterior nasal cavity. Keep the head slightly tilted and gently insert the swab into the nasal cavity (to a depth of 2-4 cm). Gently roll the swab into the nasal cavity to collect the sample. Remove the swab by turning it gently.

Test procedure
Allow the test cassette, sample and extraction solution to reach room temperature before testing. Wash and disinfect your hands before testing.
Remove the Test Cassette from the sealed pouch and use it as soon as possible. Best results are obtained if the test is performed within one hour of opening the pouch.
Place the extraction tube on the workstation. Take the bottle containing the extraction solution, turn it upside down and add 6 drops (approximately 200 mcL) to the extraction tube. Insert the swab into the extraction tube containing the extraction solution and rotate the swab approximately 10 times, pressing the swab head against the wall of the tube in order to release the antigen into the solution, then let it stand for about 1 minute. Remove the swab while pressing the tip of the swab to get as much liquid out of the swab as possible. Insert the dropper tip on the tube and close it tightly, letting it rest for one minute.
Take the test cassette and add 3 drops (approximately 100 mcL) into the sample hole (or use a pipette to add 100 mcL) and start the timer.
Wait for the colored lines to appear. The result should be read in 15 minutes. Do not interpret the result after 20 minutes.

Interpretation of results
NEGATIVE: Only the control line (C) appears, the test line (T) does not appear. No COVID-19 antigen was detected in the sample. The result is negative.
Continue to follow all regulations regarding contact with others and protective measures. Even if the test result is negative