For auto-test

Description
Single-use 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 by symptomatic individuals who are suspected have been infected by the COVID-19 virus. The quick test for the COVID-19 antigen (oral flux) provides only a preliminary result, the final confirmation must be based on clinical diagnostic results.

Mode of use
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.
1. Sample collection: remove the imbute and plastic tubes from the package, insert the imbute on the tube. Toxin deeply 3-5 times. Note: 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.
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.
3. Test execution: remove the device for tests 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 cassette 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.
4. Read the results after 15 minutes. Do not interpret the results after 20 minutes. After completing the tests. put all the components of the test kit into 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 test.
POSITIVE: two colored lines appear. A coloured line should appear in the control area (C) and another coloured line should appear in the test region (T).
NOTE: the color intensity in the test line region (T) varies depending on the SARS-CoV-2 antigen number 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 it is very likely that the person is infected by COVID-19, positive samples must be confirmed. Put yourself immediately in self-isolation as prescribed by local regulations and contact your doctor or health care district according to the instructions of local authorities. The test will be verified through a confirmation molecular test (PCR) and the instructions on the following steps will be provided.
NEGATIVE: a single coloured line appears in the control region (C). No coloured line appears in the region of the test line (T). I= unlikely to have 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. Also, you can repeat the tests 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 during travel, participation in events and so on.
INVALIDO: the control line does not appear. An insufficient sample volume or incorrect 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
1. Carefully read the leaflet before testing.
2. The test is intended exclusively for self-diagnosis in vitro.
3. Disposable test, do not reuse. Do not use after the expiry date.
4. Do not eat, coffin or smoke in the area where you manipulate samples or kits.
5. 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 abundant running water.
6. Do not use the test if the packaging is damaged.
7. Wash your hands thoroughly before and after manipulation.
8. If the preliminary result should be positive, please inform your doctor about the result and carefully follow the local instructions/regulations for COVID cases.
9. Tests performed on children and boys must be carried out in the presence of adults.
10. The test used must be disposed of according to local standards.
Limitations:
1. Failure to comply with certain steps of the test procedure can result incorrectly.
2. The rapid test for the antigen COVID-19 (oral flux) and intended exclusively for the auto-diagnosis in vitro.
3. The results obtained with the test must be considered in addition to other clinical results of other tests and laboratory evaluations.
4. 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.
5. Positive results of COVID-19 may be due to infection by non-SARS-CoV-2 virus strains or other interference factors.

Conservation
Store between 2°C-30°C.

Format
- Test device.
- Buffer solution.
- Sample collection device.
- Bio-safety bags.
- Illustrative sheet.

Cod. ICOV-802H