Description
The VivaDiagTM Pro Rapid Test for SARS-CoV-2 Ag serves for quick and qualitative detection of SARS-CoV-2 nucleocapside protein antigen in humans. The test is intended only for in vitro diagnostic use. It is indicated for the autotest. It only provides an initial result of the screening test. Alternative methods of more specific diagnosis (molecular diagnostics and/or CT) should be performed to obtain confirmation of SARS-CoV-2 infection. The decision on the diagnostic procedure is for the doctor. This test is intended for domestic use with nasal swab samples collected independently in individuals aged 16 to 69 years. The collection of samples and the execution of tests performed by subjects under the age of 16 and over the age of 69 should be done under the supervision of an adult. For people who are unable to perform the test alone, the test should be conducted by legal guardians; patients/disables (including people with vision problems) should be assisted during the test.
The Quick Test VivaDiagTM Pro SARS-CoV-2 Ag is based on immunochromatic technology. Each test device will show a line of anti-SARS-CoV-2 antibodies identified as a detection line (T line) and an IgG anti-tope line identified as a quality control line (C line). When the sample extract is added to the sample well, it will react with the marked antibody to form a complex; the mixture will then migrate through the membrane for capillary action and will interact with the antibody coated anti-SARS-CoV-2 on the detection line. If the sample contains the SARS-CoV-2 antigen, the detection line will appear red indicating that the SARS-CoV-2 antigen is positive. Otherwise, the test result will be negative. The test device also contains a C quality control line that must appear in red to validate the test. If the C quality control line is not shown, the test result will not be valid even if the detection line is present.

Mode of use
Sample collection
Front nasal swab sample Wash hands with soap and water or use a disinfectant for hands: it is important to get as much secretion as possible. Open the pack of the pad at the end of the stick and extract the pad. Don't touch the tampon's head. Insert the sterile tampon into a nostril. Make sure the entire tip of the tampon has been inserted in the nostril (about 1.5 cm). Rotate the swab 5 times on the mucosa inside the nostril to ensure that both mucus and cells are collected. Repeat this process for the other nostril to collect an adequate sample quantity from both nasal cavities (use the same swab).
Sample manipulation
Samples must be tested as soon as possible after harvesting (we recommend testing them within 5 minutes).
Test procedure
1. Open the extraction solution (in the sealed tube).
2. Collect the sample by reference to the Sample Collection section.
3. Insert the swab with the sample collected in the extraction test containing the extraction solution. Rotate the swab 5 times pressing the head against the bottom and walls of the extraction tube. Remove the pad by pressing it on the walls of the tube to extract the liquid from the buffer. Try to extract as much liquid as possible.
4. Insert the dropper tip on the tube.
5. Extract a test device from the sealed envelope and place it on a clean and flat surface.
6. Apply 3 drops of the sample extracted in the sample well. Avoid forming bubbles during application.
7. Read the test result after 15 minutes. Do not read the result after 20 minutes.
Note: do not exchange or mix the extraction solution from different batches.
Handle the extraction solution carefully, do not touch the eyes or skin. In case of contact with eyes or skin, wash thoroughly with water.
Interpretation of results
1. Positive result
Both the C quality control line and the T detection line are displayed. Any color shade in the region of the test line (T) must be considered positive.
If there is suspicion of a COVID-19 infection:
- immediately contact your doctor/family doctor or local health facility;
- follow the local guidelines for self-isolation;
- run a confirmation PCR test.
2. Negative result
Only the C quality control line is displayed, no other line appears on the detection area.
Continue to follow all applicable rules regarding contact with others and protection measures.
- An infection may be present even if the test is negative.
- In case of suspicion, since the coronavirus cannot be accurately identified at all stages of an infection, please contact your family doctor/medium or local healthcare facility immediately.
3. Result not valid
The C quality control line is not displayed, indicating that the test is not valid, regardless of whether the detection line is displayed or not. Take a new sample and run another test with a new device.
- Possibly caused by an incorrect test.
- Repeat the test.
- If the test results are not yet valid, please contact your doctor/family doctor or local health facility immediately.

Warnings
- The SARS-CoV-2 antigen test results should not be used as the only basis for diagnosing or excluding SARS-CoV-2 infection or informing about the state of the infection.
- You should not make any medical decision without consulting your doctor first.
- Negative results do not exclude SARS-CoV-2 infection, especially in those who have been in contact with the virus. Molecular and/or CT follow-up diagnostic tests must be taken into account to exclude infection in these individuals.
- Positive results may be due to an infection present with SARS-coronavirus strains. Molecular and/or CT follow-up diagnostic tests must be taken into account to confirm the test result.
- Negative results may occur if the antigen level in the sample is lower than the test detection limit.
- Imprecise results may occur due to visibly bloody or excessively thick/ sticky samples, insufficient sample volume or bubble formation during application.
- Do not use damaged or unusable buffers.
- Individuals with color vision problems may not be able to properly interpret the test results.
- Only for in vitro diagnostics, it's for the autotest.
- Keep out of the reach of children.
- Use the test device within 60 minutes of opening the aluminum envelope.
- Don't test in direct sunlight.
- Do not use the test device if it has been exposed to household cleaning products (especially bleach).
- Keep foreign substances away from the test device during the test process.
- Please take the necessary safety measures (e.g. facial mask, gloves) when testing for other people.
- The equipment used for testing and all the tested components must be disposed of in accordance with local requirements, and can be put in a well sealed bag and disposed of as domestic waste.
- A further molecular diagnostic and/or CT test is recommended to identify the actual physical situation.
- Do not open the aluminum envelope of the test device by exposing it to the surrounding environment until you are ready to use it immediately.
- Do not use damaged test devices or materials.
- Don't reuse the test device.
- Handle the extraction solution carefully, do not touch the eyes or skin. In case of contact with eyes or skin, wash thoroughly with water.
- Do not use the test kit over the expiry date.
- Take the test sample only in the front nasal part. Follow the leaflet to get accurate results.
- Wash your hands thoroughly after handling and wash your hands before collecting samples and testing.
- This test does not determine the etiology of respiratory infection caused by microorganisms other than the SARS-CoV-2 virus.
- The accuracy of the test depends on the quality of the sample collected with the buffer, negative false results can occur as a result of poor sampling.
- Failure to comply with the test procedure may have a negative impact on the test performance and/or invalidate the test result.

Conservation
Store the test kit in a dry place between 2-30 °C. Keep away from light. Exposure to temperatures and/or humidity beyond specified limits can cause unexpected results. Don't freeze. Use the test kit at temperatures between 15-30 °C. Use the test kit between 10-90% humidity. Do not use the test kit over the expiry date.
Integro packaging validation: 24 months.

Format
1 test, 1 reagent (in the sealed test tube), 1 meter cap, 1 test holder, 1 sterile swab, illustrious leaflet.

Cod. VCD-16-10-013