Description
Test kit for the in vitro qualitative detection of 2019-nCoV antigen. Immunochromatographic test with double "sandwich" antibody intended to detect the 2019-nCoV protein N antigen in human nasal swab samples.
It can be used to test individuals with or without symptoms suspected of being infected with COVID-19.
A positive result indicates COVID-19 infection - quarantine and contact a doctor. Confirm the result with a PCR test.
A negative result should be considered presumptive, as it does not rule out COVID-19 infection. Negative results should be considered in the context of the patient's recent exposures, medical history, and the presence of clinical signs and symptoms consistent with COVID-19. Negative results should be confirmed with a PCR test if necessary.
The kit uses the "sandwich" double antibody method to detect novel coronavirus (2019-nCoV) antigen in nasal swab samples.
During the test, the gold-labeled anti-2019-nCoV monoclonal antibody binds to the 2019-nCoV antigen in the sample, thus forming a complex. The complex will simulate along the nitrocellulose membrane under the action of chromatography and will be captured by the pre-coated anti-2019-nCoV monoclonal antibody in the test area (T) on the nitrocellulose membrane.
At the end of the procedure, if the sample contains 2019-nCoV antigen a red colored line should form in the test area (T).
In the event that the sample does not contain the 2019-nCoV antigen, no red line will form in the test area.
Regardless of whether or not the red line appears in the test area, a red line should always form in the quality control area (C), indicating that the test was performed correctly.
Kit suitable for self-test.

How to use
Read the instructions for use carefully before starting the test.
The Test Cassette must be used within 1 hour of removing the foil pouch.
Test components should be brought to room temperature (15-30 ° C) 30 minutes prior to testing.
The use of gloves is recommended during the test.
Do not remove the swab from the package until specimen collection and do not touch the absorbent tip of the swab.

Collection of samples
Insert the absorbent tip of the swab into one nostril, to a depth of about 2-3 cm, and rotate it firmly against the inside of the nostril more than 5 times. Remove the swab, insert it into the other nostril and repeat the procedure.

In the event that the sample is not collected correctly, false negative results may occur.
Samples should be tested as soon as possible after collection (within half an hour). Samples must not be inactivated.

Sample processing
Open the cap of the extraction tube.
Immerse the swab with the sample in the tube and rotate it at least 10 times in the solution, applying finger pressure. Remove the swab by pressing the sides of the tube with your fingers to extract the liquid with the sample from the swab.
Screw the cap tightly onto the tube.
Snap off the top of the cap: the extraction solution in the tube is ready for testing.

Sample testing
Place the test cassette on a flat surface.
Add 3 drops of Extraction Solution to the sample well and start the timer. When the test starts working you will see the color move across the result window in the center of the test cassette.
Read the result after 15 minutes. No.