Description
Test kit for the in vitro qualitative detection of 2019-nCoV antigen. Double "sandwich" antibody immunochromatographic assay intended to detect protein N 2019-nCoV 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 testing, the gold-labeled anti-2019-nCoV monoclonal antibody 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 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 the 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 successfully.
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.

If the sample is not collected correctly, false negative results can 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 pressure with your fingers. 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. Do not read the result after more than twenty minutes.

Interpretation of results
Positive: Both the line in the test area (T) and the line in the quality control area (C) are visible after 15 minutes. The test result is positive and valid.
It is likely that the person has been infected with COVID-19. Contact a doctor or local health office. No medical decisions should be made before consulting your doctor. Adhere to the self-isolation guidelines and perform 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 respect all rules of hygiene and social distancing. Even if the test result is negative, there may still be an infection taking place. If suspected, repeat the test after 1-2 days as COVID-19 may not be accurately detectable at all stages of the infection. If necessary, perform a confirmatory PCR test.

Invalid: The line in the quality control area (C) does not appear. The non-appearance of the line in the control area may have been caused by an incorrect procedure. Repeat the test using a new Test Cassette. If the problem persists, contact your distributor.

Warnings
For in vitro diagnostic use. Do not swallow.
Read the instructions for use carefully before starting the test.
Do not mix kit components from different lots.
Do not use the kit after the expiration date printed on the package.
Use appropriate precautions in the collection, handling, storage and disposal of used specimens and kit components.
Do not touch the absorbent tip of the swab.
Do not open the foil pouch containing the Test Cassette until you are ready for testing.
Do not use if the package is not intact or perfectly sealed. Do not use damaged or dropped test cassettes or materials.
The test should be performed in an area with adequate ventilation.
Improper collection, processing, storage and transport of specimens can lead to false positive or false negative results.
For accurate results, do not use visually bloody or excessively viscous samples.
Do not use a Test Cassette that has been opened and exposed to air.
Keep out of reach of children.
The device is for use by an adult.
Wear a safety mask or other face cover when collecting specimens from a child or other individual.
Use nitrile, latex (or equivalent) gloves when handling specimens.
The extraction solution contains a saline solution. If the solution contacts the skin or eyes, rinse thoroughly with water.
Wash hands thoroughly after handling samples.
Samples and test components used are infectious waste: dispose of according to local regulations.
A false negative result can occur if the antigen level in the sample is below the detection limit of the test or if the sample was improperly collected or transported.
Bring the test components to room temperature (15-30 ° C) before testing, otherwise the results may be incorrect.
Failure to follow the test procedure may adversely affect test performance and / or invalidate the result.
Results read before 15 minutes may give false negative results. Results read beyond 20 minutes may give false positive results.
A positive result does not rule out co-infections with other pathogens.
A negative result does not rule out other viral or bacterial infections.
Test results should be considered presumptive and confirmed with a molecular test if necessary.
Users should test samples as quickly as possible after collection.
If the sample volume is insufficient, the test cannot be performed successfully.

storage
Store at 2-30 ° C. Avoid exposure to sunlight, humidity and localized heat sources. Do not freeze any test contents.
The Test Cassette must be used within one hour of removing the foil pouch.
Validity for intact packaging: 24 months.

Format
The kit contains:
- 1 foil pouch (containing test cassette and desiccant);
- 1 swab;
- 1 extraction tube;
- 1 instructions for use.

Bibliography
1. Disease Control and Prevention Center. Interim Guidelines for Collection, Handling, and Analysis of Clinical Specimens for COVID-19, May 22.
2. Wu F, Zhao S, Yu B, et. to the. A novel 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-0685C2X001