Description
Test kit for quality detection in vitro of the 2019-nCoV antigen. Immunchromatic test with double antibody "sandwich" intended to detect protein N antigen 2019-nCoV in human nasal swab samples.
It can be used to test individuals with or without suspected symptoms of being infected by COVID-19.
A positive result indicates COVID-19 infection: quarantin and contact a doctor. Confirm the result with a PCR test.
A negative result should be considered presumed, as it does not exclude COVID-19 infection. Negative results should be considered in the context of recent patient exposures, medical history and the presence of signs and clinical symptoms consistent with COVID-19. Negative results must be confirmed with a PCR test if necessary.
The kit uses the "sandwich" double antibody method to detect the antigen of the new coronavirus (2019-nCoV) in nasal swab samples.
During the test, the antibody monoclonal anti-2019-nCoV marked with gold, binds to the 2019-nCoV antigen in the sample, thus forming a complex. The complex will move along the nitrocellulose membrane under the action of chromatography and will be captured by the anti-2019-nCoV pre-coated monoclonal antibody in the test area (T) on the nitrocellulose membrane.
At the end of the process, if the sample contains the 2019-nCoV antigen a red line should form in the test area (T).
If the sample does not contain the 2019-nCoV antigen, no red line will be formed in the test area.
Regardless of the appearance or not of the red line in the test area, a red line will always have to form in the quality control area (C), indicating that the test was performed correctly.
Kit suitable for the autotest.

Mode of use
Carefully read the instructions for use before starting the test.
The test box must be used within 1 hour from the removal of the aluminum bag.
Test components must be brought to room temperature (15-30 °C) 30 minutes before testing is performed.
The use of gloves is recommended during testing.
Do not remove the pad from the pack until the harvesting of the samples and do not touch the absorbent tip of the pad.

Sample collection
Insert the absorbent tip of the tampon into a nostril, at a depth of about 2-3 cm, and rotate it firmly against the inside of the nostril for more than 5 times. Extract the tampon, insert it into the other nostril and repeat the procedure.

If the sample is not harvested correctly, false negative results may occur.
Samples must be tested as soon as possible after harvesting (within half an hour). Samples should not be inactivated.

Sample processing
Open the cap of the extraction test.
Dip the swab with the sample into the tube and rotate it for at least 10 times in the solution, applying pressure with your fingers. Remove the swab by pressing with the fingers the sides of the test tube to extract the liquid with the sample from the swab.
Strictly screw the cap on the test tube.
Break the top of the cap: the extraction solution in the test tube is ready for testing.

Sample Test
Place the test box on a flat surface.
Add 3 drops of extraction solution to the sample well and start the timer. When the test begins to work you will see the color move along the result window to the center of the test box.
Read the result after 15 minutes. Do not read the result after more than twenty minutes.

Interpretation of results
Positive: both the line in the test area (T) and the quality control area (C) are visible after 15 minutes. The test result is positive and valid.
It is likely that the person was infected by COVID-19. Contact a local doctor or health office. No medical decision should be taken before consulting the doctor. Respect the self-isolation guidelines and run a PCR test to confirm the result.

Negative: the line in the quality control area (C) is visible while the line in the test area (T) does not appear. The result is negative and valid.
Continue to comply with all norms of hygiene and social space. Although the test result is negative, there may still be an infection in place. In case of suspect, repeat the test after 1-2 days as COVID-19 may not be accurately detectable at all stages of the infection. If necessary, run a confirmation PCR test.

Invalid: the line in the control area (C) quality does not appear. The failure of the line in the control area could have been caused by incorrect procedure. Repeat the test using a new test box. If the problem persists, contact the distributor.

Warnings
For in vitro diagnostics. Don't swallow.
Carefully read the instructions for use before starting the test.
Do not mix components of different batch kits.
Do not use the kit after the printed expiration date on the package.
Use the appropriate precautions in the collection, manipulation, conservation and disposal of samples and kit components used.
Don't touch the tampon absorbent tip.
Do not open the aluminum bag containing the test box until you are ready for testing.
Do not use if the packaging does not appear integrated or perfectly sealed. Do not use test boxes or damaged or fallen materials.
The test must be performed in an area with adequate ventilation.
The collection, processing, preservation and improper transport of samples can lead to false positive or false negative results.
To achieve accurate results, do not use visually bleeding or excessively viscous samples.
Do not use a test box that has been opened and exposed in the air.
Keep out of reach of children.
The device must be used by an adult.
Wear a safety mask or other face covers when collecting samples from a child or another individual.
Use nitrile gloves, latex (or equivalent) when manipulating samples.
The extraction solution contains a saline solution. If the solution comes into contact with the skin or eyes, rinse thoroughly with water.
Wash your hands thoroughly after manipulating the samples.
Samples and test components are infectious waste: dispose of according to local law.
A negative false result may occur if the antigen level in the sample is lower than the test detection limit or if the sample has been collected or transported improperly.
Bring the test components to ambient temperature (15-30 °C) before the test, otherwise the results could be wrong.
Failure to comply with the test procedure may adversely affect the performance of the test and/or invalidate the result.
Results read before 15 minutes can give rise to negative false results. Results read over 20 minutes can give rise to false positive results.
A positive result does not exclude co-infections with other pathogenic agents.
A negative result does not exclude other viral or bacterial infections.
The results of the test must be considered presumed and confirmed with a molecular test if necessary.
Users should test samples as quickly as possible after harvesting.
If the sample volume is not enough, the test cannot be successfully performed.

Conservation
Store at 2-30 °C. Avoid exposure to sunlight, moisture and localized heat sources. Do not freeze any test content.
The test box must be used within an hour of removing the aluminum bag.
Validity of whole packaging: 24 months.

Format
The kit contains:
- 1 aluminum bag (containing test box and drying);
- 1 buffer;
- 1 extraction test;
- 1 instructions for use.

Bibliography
1. Disease control and prevention centre. Provisional guidelines for the collection, handling and analysis of clinical samples for COVID-19, 22 May.
2. Wu F, Zhao S, Yu B, et al. A new coronavirus associated with human respiratory diseases in China. Nature.2020;579:265-9.
3. https://www.who.int/publications/i/item/antigen-detection-in-the-diagnosis-of-sars-cov-2-infection-using-rapid- immunoassays

Cod. G-0685C2