Description
Rapid test for the rapid and qualitative detection of proteinnucleocapsid antigen of SARS-CoV-2 in humans.
The test is intended for in vitro diagnostic use only. It is indicated for the self-test. Provides an initial screening test result only. More specific alternative diagnostic methods (molecular diagnostic and/or CT) should be performed to obtain confirmation of SARS-CoV-2 infection. The decision on the diagnostic procedure rests with the doctor.
The test is based on immunochromatography technology. Each test device has one SARS-CoV-2 antibody line, identified as the detection line (T-line), and one anti-mouse IgG antibody line, identified as the quality control line (C-line).
When the extracted sample is added to the sample well, it will react with the labeled antibody to form a complex; the mixture will then migrate across the membrane by capillary action and interact with the anti-SARS-CoV-2 coated antibody at the detection line.
If the sample contains SARS-CoV-2 antigen, the detection line will appear red indicating that SARS-CoV-2 antigen is positive. Otherwise, the test result will be negative.
The test device also contains a quality control line (C line) which should turn red to verify that the test was performed correctly and is valid. If the quality control line (C line) does not appear, the test result will be invalid even if the detection line is present.
The test is intended for home use with self-collected nasal swab specimens in individuals aged 16 to 69 years. Specimen collection and testing from individuals under the age of 16 and over the age of 69 should be done under adult supervision. For individuals who are unable to test on their own, testing should be conducted by legal guardians; sick/disabled people (including people with vision problems) should be assisted during the test.

How to use
Sample collection and handling
Wash your hands with soap and water or use hand sanitizer.
Open the swab pouch at the end of the stick and remove the swab. Do not touch the swab head.
Insert the sterile swab into one nostril. Make sure that the entire tip of the swab has been inserted into the nostril (approximately 1.5cm deep). Rotate the swab 5 times on the mucosa inside the nostril to ensure that both mucus and cells are collected. Repeat this process for the other nostril to collect an adequate amount of sample from both nasal cavities (use the same swab).
Specimens should be tested as soon as possible after collection (testing within 5 minutes of collection is recommended).

Testing procedure
Allow the test devices and extraction solution to equilibrate to 15-30°C before testing.
Open the extraction solution (in the sealed tube). Insert the swab with the collected sample into the extraction tube containing the extraction solution. Rotate the swab 5 times by pressing the swab head against the bottom and sides of the tube. Remove the swab by pressing it against the walls of the tube to extract the liquid from the swab. Try to extract as much liquid as possible.
Insert the dropper tip on the tube. Remove a test device from the sealed pouch and place it on a clean, flat surface.
Apply 3 drops of the extracted sample to the sample well on the cassette