Description
Test indicated for the rapid and qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in humans.
The test provides a preliminary screening test result. To confirm SARS-CoV-2 infection, more specific alternative diagnostic investigations (molecular diagnostics and/or CT) must be performed. The doctor must decide on the diagnostic procedure.
The test is based on immunochromatic technology. Each test cassette contains one line with anti-SARS-CoV-2 antibodies on the detection line (T) and one line with anti-mouse IgG antibodies on the control line (C). When the sample is added to the well of the device, it reacts with the labeled antibody, forming a complex. The mixture then migrates across the membrane by capillary action and interacts with the anti-SARS-CoV-2 antibody on the detection line.
If the sample contains SARS-CoV-2 antigen, the detection line appears red, indicating the presence of SARS-CoV-2 antigen. Otherwise, the test result will be negative.
The cassette also contains a control line (C) which should appear red in all valid tests. If the control line does not appear, the test result is invalid even if the detection line appears.
This test is intended for home use with self-collected nasal swab specimens in individuals aged 16 to 69 years. The collection of samples and the execution of the test performed by subjects under the age of 16 years and over 69 years should be done under the supervision of an adult. For people who are unable to perform the test themselves, the test should be conducted by legal guardians; Sick/disabled people (including visually impaired people) should be assisted during the test.
The test is intended for in vitro diagnostic use only. It is suitable for self-testing.

Instructions for use
Sample collection
Wash your hands with soap and water or use hand sanitizer: it is important to get as much secretion as possible.
Open the swab package 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 1.5 cm deep). Rotate the swab 5 times over 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).
Samples should be tested as soon as possible after collection (it is recommended to test within 5 minutes).

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 pressing the head against the bottom and walls of the extraction tube. Remove the swab by pressing it on the walls of the tube to extract the liquid from the swab. Try to extract as much liquid as possible. Insert the dropper tip onto the test 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. Avoid the formation of bubbles during application.
Read the test result after 15 minutes. Do not read the result after 20 minutes.

Interpretation of results
POSITIVE: are displayed