Description
Single-use test designed to detect the novel SARS-CoV-2 coronavirus that causes COVID-19 in human oral fluid.
The test is designed for home use with self-collection of oral fluid samples from symptomatic individuals suspected of being infected with the COVID-19 virus.
It is a qualitative membrane-based immunoassay for the determination of SARS-CoV-2 antigens in human oral fluid samples.
The test provides a preliminary result only, the final confirmation must be based on clinical diagnostic results.

How to use
Before testing, do not put anything in your mouth, including food, drink, chewing gum, or tobacco products for at least 10 minutes prior to testing.
Wash your hands with soap and water for at least 20 seconds before performing the test. If soap and water are not available, use a hand sanitizer with at least 60% alcohol.

Step 1: Collect the sample
Remove the funnel and the plastic tube from the packaging, insert the funnel on the tube. Cough deeply 3-5 times.
Note: Wear a face mask or cover your mouth and nose with a cloth while coughing and keep distance from bystanders.
Gently spit the oral fluid into the funnel. The oral fluid (without bubbles) should reach the height indicated by the reference line.
Note: If insufficient fluid is collected, repeat the sample collection steps.
Insert the used funnel into the bio-safety bag.

Step 2: Sample Preparation
Place the tube in the plastic holder. Pull to open the buffer solution and pour all the solution into the tube with the oral fluid. Insert the cap on the tube. Gently squeeze the tube 10-15 times to mix well.

Step 3: Run the test
Remove the test device from the sealed pouch and use it within one hour. The best results are obtained if the test is performed immediately after opening the foil pouch.
Place the test device on a flat surface. Invert the tube and pour 2 drops of solution into the well (S) of the test device and then start the timer. Do not move the device while the test is running.
Read the results after 15 minutes. Do not interpret the results after 20 minutes.
After completing the test, place all test kit components in the biosafety pouch and dispose of it according to local regulations. Do not reuse any of the used kit components.
Wash your hands thoroughly after disposing of the test.

Step 4: Reading the results
Inform your treating physician of the results and carefully follow local instructions / regulations for COVID cases.

- POSITIVE: * two colored lines appear. One colored line should appear in the control region (C) and another colored line should appear in the test region (T). A positive result means that it is very likely that the person is infected with COVID-19, positive samples must be confirmed. Immediately self-isolate as prescribed by local regulations and contact your treating physician or health care district as directed by local authorities. The test should be verified by a confirmatory molecular test (PCR) and instructions on the following steps will be provided.
* NOTE: The intensity of the color in the test line region (T) varies depending on the number of SARS-CoV-2 antigens present in the sample. Therefore the presence of any shade of color in the test region (T) should be interpreted as a POSITIVE result.

- NEGATIVE: only one colored line appears in the control region (C). No colored lines appear in the test line region (T). The person is unlikely to have contracted COVID-19. However, it is possible that this test will give an incorrect result (a false negative) in some people with COVID-19. This means that you may have contracted COVID-19 even if the test gave a negative result.
In case of symptoms such as headache, migraine, fever, loss of taste and smell, please contact the nearest health care point according to local authority rules. Also, you can repeat the test with a new kit. If suspected, repeat the test after 1-2 days, as the coronavirus cannot be determined at all stages of the infection.
Even with a negative result, the rules of spacing and hygiene must continue to be observed, mitigation / travel, participation in events and so on should follow local COVID guidelines / requirements.

- INVALID: the control line does not appear. Insufficient sample volume or incorrect procedure are the most likely causes of missing control line. Review the procedure and repeat the test with a new kit or contact your doctor or a COVID-19 diagnosis center.

Warnings
Read the package insert carefully before performing the test.
The test is intended for in vitro self-diagnosis only.
Test is single use, do not reuse. Do not use after the expiration date.
Do not eat, drink or smoke in the area where specimens or kits are handled.
Do not drink the buffer solution from the kit. Handle the buffer solution with care and avoid contact with skin and eyes, in case of contact rinse immediately with plenty of running water.
Do not use the test if the package is damaged.
Wash hands thoroughly before and after handling.
If the preliminary result is positive, inform your doctor of the result and carefully follow the local instructions / regulations for COVID cases.
Tests performed on children and teenagers must be carried out in the presence of adults.
Used test must be disposed of according to local regulations.
Failure to follow some steps of the test procedure may result in incorrect results.
The results obtained with the test should be considered in addition to other clinical results of other tests and laboratory evaluations.
If the test result is negative or non-reactive but clinical symptoms persist, it is because the virus may not be detectable in the early stage of infection. It is recommended to repeat the test with a new test 1-2 days later or to go to the hospital to rule out infection.
Positive COVID-19 results may be due to infection with non-SARS-CoV-2 virus strains or other interfering factors.

storage
Store the test at temperatures between 2-30 ° C. Do not freeze.
Do not open the package until you are ready to test.
Validity for intact packaging: 12 months.

Format
The kit contains:
• Test device;
• Sample collection device (funnel, tube and tube cap);
• Buffer solution;
• Package leaflet;
• Bio-security bags.

Bibliography
1. BACKINGER, CL and KINGSLEY, PA, Write It Right: Recommendations for Developing User Instruction Manuals for Medical Devices Used in Home Health Care, Rockville, MD, US Food and Drug Administration, Center for Devices and Radiological Health, HHS Pub. FDA 93-4258.