Description
Disposable test designed to detect the new SARS-CoV-2 coronavirus that causes COVID-19 in the human oral fluid.
The test is designed for domestic use, with the self-harvest of oral fluid samples from symptomatic individuals who are suspected have been infected by the COVID-19 virus.
The test only provides a preliminary result, the final confirmation must be based on clinical diagnostic results.

Mode of use
Before testing
Do not put anything in your mouth, including food, drinks, chewing gums or tobacco-based products for at least 10 minutes before running the test.
Wash your hands with soap and water for at least 20 seconds before testing. If no soap and water are available, use a hand disinfectant with at least 60% alcohol.

Step 1: Sample collection
Remove the imbute and plastic tube from the package, insert the imbute on the tube.
Toxin deeply 3-5 times. Wear a facial mask or cover mouth and nose with a cloth while coughing and keeping the distance from the present.
Gently tap the oral fluid into the funnel. The oral fluid (without bubbles) should reach the height indicated by the reference line. If the crop fluid is not enough, repeat the steps for sample collection.
Insert the funnel used in the bio-safety bag.

Step 2: Sample preparation
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 compress the tube for 10-15 times to mix well.

Step 3: Test execution
Remove the test device from the sealed case and use it within an hour. The best results are obtained if the test is performed immediately after the opening of the aluminum envelope.
Place the test box on a flat surface. Rotate the tube and pour 2 drops of solution into the test device (S) well and then start the timer.
Do not move the test cassette during the test.

Step 4:
Read the results after 15 minutes. Do not interpret the results after 20 minutes.
After completing the test, put all the components of the test kit in the bio-safety bag and dispose of it according to local regulations. Do not reuse any of the components of the kit used.
Wash your hands thoroughly after disposing the tests.

Reading results
Informing your doctor about the results and carefully follow the local instructions/regulations for COVID cases.

POSITIVE: two colored lines appear. A coloured line should appear in the control area (C) and another should appear in the test region (T). The color intensity in the region of the test line (T) varies depending on the number of SARS-CoV-2 antigens present in the sample. Therefore the presence of any color shade in the test region (T) must be interpreted as a positive result.
A positive result means that people are very likely to be infected by COVID-19.
Positive samples must be confirmed. Put yourself immediately in self-isolation as prescribed by local regulations. The test will be verified through a confirmation molecular test (PCR) and the instructions on the following steps will be provided.

NEGATIVO: a single coloured line appears in the control area (C). No coloured line appears in the region of the test line (T).
It is unlikely that the person is infected by COVID-19. However, it is possible that this test gives an incorrect result (a false negative) in some people with COVID-19. This means that you could have contracted COVID-19 even if the test gave a negative result. In case of symptoms such as headaches, migraine, fever, loss of taste and smell, contact the nearest healthcare point according to the rules of the local authority. In addition, you can repeat the test with a new kit.
In case of suspect, repeat the test after 1-2 days, since the coronavirus cannot be determined at all stages of the infection.
Even with a negative result, the rules of space and hygiene must continue to be observed.

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

Warnings
Carefully read the leaflet before testing.
The test is intended exclusively for self-diagnosis in vitro. The test is disposable, do not reuse. Do not use after the expiry date.
Do not eat, drink or smoke in the area where you manipulate samples or kits.
Do not drink the buffer solution in the kit. Manipulate 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 your hands thoroughly before and after manipulation.
If the preliminary result should be positive, please inform your doctor about the result and carefully follow the local instructions/regulations for COVID cases.
Tests performed on children and boys must be carried out in the presence of adults.
The test used must be disposed of according to local standards.
Failure to comply with certain steps of the test procedure can result incorrectly.
The results obtained with the test must be considered in addition to other clinical test results 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 exclude the infection.
Positive results of COVID-19 may be due to infection by non-SARS-CoV-2 virus strains or other interference factors.

Conservation
Store the test at temperatures between 2-30 °C. Don't freeze.
Do not open the package until you are ready to run the test.
Validity of whole packaging: 24 months.

Format
The kit contains:
- 1 test device;
- 1 sample collection device (imbute, tube and tube tip);
- 1 buffer solution;
- 1 leaflet;
- 1 bag of bio-security.

Bibliography
1. BACKINGER, C.L. and KINGSLEY, P.A., Recommendations for Developing User Instruction Manuals for Medical Devices Used in Home Health Care, Rockville, MD, U.S. Food and Drug Administration, Center for Devices and Radiological Health, HHS Pub. FDA 93-4258.

Cod. ICOV-802H