Description
Single-use test intended 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. The test is intended for use in symptomatic individuals who meet the case definition for COVID-19, as well as in asymptomatic individuals, limited to contacts of confirmed or probable COVID-19 cases and at-risk healthcare workers.
It is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 antigens in human oral fluid samples.
The test provides only a preliminary result; final confirmation must be based on clinical diagnostic results.

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

Step 1: Sample Collection
Remove the funnel and plastic tube from the packaging, insert the funnel onto the tube.
Cough deeply 3-5 times. Wear a face mask or cover your mouth and nose with a cloth while coughing and maintain distance from others.
Gently spit oral fluid into the funnel. The oral fluid (without bubbles) should reach the height indicated by the reference line.
If the collected fluid is not sufficient, repeat the sample collection steps.
Insert the used funnel into the biohazard bag.

Step 2: Sample Preparation
Tear open the buffer solution and pour all the solution into the tube with the oral fluid. Insert the cap onto the tube. Gently squeeze the tube 10-15 times to mix well.

Step 3: Performing the Test
Remove the test device from the sealed pouch and use it within one hour. Best results are obtained if the test is performed immediately after opening the foil pouch.
Place the test cassette on a flat surface.
Invert the tube and dispense 2 drops of solution into the sample well (S) of the test device and then start the timer.
Do not move the test cassette during the test.

Step 4:
Read results after 15 minutes. Do not interpret results after 20 minutes.
After completing the test, place all test kit components into the biohazard bag and dispose of according to local regulations.
Do not reuse any of the used kit components.
Wash hands thoroughly after disposing of the test.

Reading Results
Inform your doctor 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). The intensity of the color in the test line region (T) will vary depending on the amount of antigens present in the sample. Therefore, any shade of color in the test region (T) should be interpreted as a positive result. A positive result means it is very likely that the person is infected with COVID-19.
Positive samples must be confirmed. Self-isolate immediately, as prescribed by local regulations, and contact your doctor or healthcare district as per local authority instructions. The test will be verified by a confirmatory molecular test (PCR) and instructions on next steps will be provided.

- NEGATIVE: Only one colored line appears in the control region (C). No colored line appears in the test line region (T). It is unlikely that the person is infected with COVID-19. However, it is possible for the test to give an incorrect result (false negative) in some people with COVID-19. This means you could have contracted COVID-19 even if the test result was negative.
In case of symptoms such as headache, migraine, fever, loss of taste and smell, contact the nearest healthcare facility, according to local authority rules.
It is possible to repeat the test with a new kit. If in doubt, repeat the test after 1-2 days, as the coronavirus cannot be detected at all stages of infection.
Even with a negative result, social distancing and hygiene rules must continue to be observed.

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

Warnings
Read the instruction leaflet carefully before performing the test.
The test is for in vitro self-diagnosis only. Single-use test, do not reuse.
Do not use after the expiration date.
Do not eat, drink, or smoke in the area where samples or kits are handled.
Do not drink the buffer solution in 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 packaging is damaged.
Wash hands thoroughly before and after handling.
If the preliminary result is positive, inform your doctor of the result and carefully follow local instructions/regulations for COVID cases.
Tests performed on children and adolescents must be carried out in the presence of adults.
The used test must be disposed of according to local regulations.
Failure to observe some steps of the test procedure may generate incorrect results.
Results obtained with the test should be considered in addition to other clinical results from 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 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 at temperatures between 2 °C and 30 °C. Do not freeze.
Do not open the package until you are ready to perform the test.
Shelf life when unopened: 24 months.

Format
The kit contains:
- Test device;
- Sample collection device (funnel, tube, and tube tip);
- Buffer solution;
- Instruction leaflet;
- Biohazard bag.

Code ICOV-802HALL