Description
VivaDiag Pro
Rapid Test
Description
The VivaDiagTM Pro Rapid Test for SARS-CoV-2 Ag is intended for the rapid and qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in humans. The test is intended for in vitro diagnostic use only. It is intended for self-testing. It provides only an initial screening test result. More specific alternative diagnostic methods (molecular diagnostics and/or CT) should be performed to obtain confirmation of SARS-CoV-2 infection. The decision on the diagnostic procedure is up to the physician. This test is intended for home use with self-collected nasal swab specimens in individuals aged 16 to 69 years. Specimen collection and testing by individuals aged under 16 and over 69 years should be done under the supervision of an adult. For individuals who are unable to perform the test themselves, the test should be conducted by legal guardians; ill/disabled individuals (including visually impaired individuals) should be assisted during the test.
The VivaDiagTM Pro SARS-CoV-2 Ag Rapid Test is based on immunochromatography technology. Each test device will display one anti-SARS-CoV-2 antibody line labeled as the detection line (T line) and one anti-mouse IgG antibody line labeled as the quality control line (C line). When the extracted sample is added to the sample well, it will react with the labeled antibody to form a complex; the mixture will then migrate through the membrane by capillary action and interact with the coated anti-SARS-CoV-2 antibody on the detection line. If the sample contains 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 quality control line C which must appear red to validate the test. If the quality control line C is not shown, the test result will be invalid even if the detection line is present.
How to use
Sample collection
Anterior nasal swab sample Wash your hands with soap and water or use hand sanitizer - it is important to get as much of the secretion as possible. Open the swab package at the end of the stick and remove the swab. Do not touch the head of the swab. Insert the sterile swab into one nostril. Make sure the entire tip of the swab is inserted into the nostril (about 1.5 cm). Rotate the swab 5 times on the mucosa inside the nostril to ensure both mucus and cells are collected. Repeat this process for the other nostril to collect an adequate amount of sample from both nasal cavities (use the same swab).
Sample manipulation
Samples should be tested as soon as possible after collection (it is recommended to test within 5 minutes).
Test procedure
1. Open the extraction solution (in the sealed tube).
2. Collect the sample referring to the Specimen Collection section.
3. Insert the swab with the collected sample into the extraction tube containing the extraction solution. Rotate the swab 5 times by pressing the head against the bottom and walls of the extraction tube. Remove the swab by pressing it against the walls of the tube to extract the liquid from the swab. Try to extract as much liquid as possible.
4. Insert the dropper tip into the test tube.
5. Remove a test device from the sealed pouch and place it on a clean, flat surface.
6. Apply 3 drops of the extracted sample into the sample well. Avoid bubbles during application.
7. Read the test result after 15 minutes. Do not read the result after 20 minutes.
Note: Do not interchange or mix extraction solution from different batches.
Handle the extraction solution with caution, do not touch your eyes or skin. In case of contact with eyes or skin, wash thoroughly with water.
Interpretation of results
1. Positive result
Both the quality control line C and the detection line T are displayed. Any shade of color in the test line (T) region should be considered positive.
If there is suspicion of COVID-19 infection:
- contact your doctor/family doctor or local health facility immediately;
- follow local guidelines for self-isolation;
- perform a confirmatory PCR test.
2. Negative result
Only the quality control line C is displayed, no other lines appear on the detection area.
Continue to follow all applicable rules regarding contact with others and protective measures.
- An infection may be present even if the test is negative.
- If you suspect coronavirus, as it cannot be accurately detected at all stages of an infection, contact your GP/family doctor or local health facility immediately.
3. Invalid result
The quality control line C does not appear, indicating that the test is invalid, regardless of whether the detection line appears or not. Collect a new sample and perform another test with a new device.
- Possibly caused by an incorrect test.
- Repeat the test.
- If your test results are still invalid, contact your doctor/family doctor or local health facility immediately.
Warnings
- SARS-CoV-2 antigen test results should not be used as the sole basis for diagnosing or excluding SARS-CoV-2 infection or for informing about the status of the infection.
- No medical decisions should be made without first consulting your doctor.
- Negative results do not exclude SARS-CoV-2 infection, especially in those who have been in contact with the virus. Follow-up molecular diagnostic testing and/or CT should be considered to rule out infection in these individuals.
- Positive results may be due to a current infection with SARS-coronavirus strains. Follow-up molecular diagnostic testing and/or CT should be considered to confirm the test result.
- Negative results may occur if the antigen level in the specimen is below the detection limit of the test.
- Inaccurate 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 swabs.
- Individuals with color vision problems may not be able to adequately interpret test results.
- For in vitro diagnostic use only, it is for self-testing.
- Keep out of reach of children.
- Use the test device within 60 minutes of opening the foil pouch.
- Do not perform the 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 testing process.
- Please take necessary safety measures (e.g. face mask, gloves) when testing other people.
- The equipment used for the test and all tested components must be disposed of in accordance with local requirements, and can be placed in a well-sealed bag and disposed of as household waste.
- Further molecular diagnostic testing and/or CT is recommended to identify the actual physical situation.
- Do not open the foil pouch of the test device and expose it to the surrounding environment until you are ready to use it immediately.
- Do not use damaged devices or test materials.
- Do not reuse the test device.
- Handle the extraction solution with caution, do not touch your eyes or skin. In case of contact with eyes or skin, wash thoroughly with water.
- Do not use the test kit beyond the expiration date.
- Collect the test sample from the anterior nasal area only. Follow the package insert to obtain accurate results.
- Wash hands thoroughly after handling and wash hands before specimen collection 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 swab, false negative results may occur as a result of poor sampling.
- Failure to follow the test procedure may negatively impact 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 the specified limits may cause inaccurate results. Do not 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 beyond the expiration date.
Validity of intact packaging: 24 months.
Format
1 test, 1 reagent (in sealed tube), 1 measuring cap, 1 tube holder, 1 sterile swab, information leaflet.
Cod. VCD-16-10-013
The VivaDiagTM Pro Rapid Test for SARS-CoV-2 Ag is intended for the rapid and qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in humans. The test is intended for in vitro diagnostic use only. It is intended for self-testing. It provides only an initial screening test result. More specific alternative diagnostic methods (molecular diagnostics and/or CT) should be performed to obtain confirmation of SARS-CoV-2 infection. The decision on the diagnostic procedure is up to the physician. This test is intended for home use with self-collected nasal swab specimens in individuals aged 16 to 69 years. Specimen collection and testing by individuals aged under 16 and over 69 years should be done under the supervision of an adult. For individuals who are unable to perform the test themselves, the test should be conducted by legal guardians; ill/disabled individuals (including visually impaired individuals) should be assisted during the test.
The VivaDiagTM Pro SARS-CoV-2 Ag Rapid Test is based on immunochromatography technology. Each test device will display one anti-SARS-CoV-2 antibody line labeled as the detection line (T line) and one anti-mouse IgG antibody line labeled as the quality control line (C line). When the extracted sample is added to the sample well, it will react with the labeled antibody to form a complex; the mixture will then migrate through the membrane by capillary action and interact with the coated anti-SARS-CoV-2 antibody on the detection line. If the sample contains 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 quality control line C which must appear red to validate the test. If the quality control line C is not shown, the test result will be invalid even if the detection line is present.
How to use
Sample collection
Anterior nasal swab sample Wash your hands with soap and water or use hand sanitizer - it is important to get as much of the secretion as possible. Open the swab package at the end of the stick and remove the swab. Do not touch the head of the swab. Insert the sterile swab into one nostril. Make sure the entire tip of the swab is inserted into the nostril (about 1.5 cm). Rotate the swab 5 times on the mucosa inside the nostril to ensure both mucus and cells are collected. Repeat this process for the other nostril to collect an adequate amount of sample from both nasal cavities (use the same swab).
Sample manipulation
Samples should be tested as soon as possible after collection (it is recommended to test within 5 minutes).
Test procedure
1. Open the extraction solution (in the sealed tube).
2. Collect the sample referring to the Specimen Collection section.
3. Insert the swab with the collected sample into the extraction tube containing the extraction solution. Rotate the swab 5 times by pressing the head against the bottom and walls of the extraction tube. Remove the swab by pressing it against the walls of the tube to extract the liquid from the swab. Try to extract as much liquid as possible.
4. Insert the dropper tip into the test tube.
5. Remove a test device from the sealed pouch and place it on a clean, flat surface.
6. Apply 3 drops of the extracted sample into the sample well. Avoid bubbles during application.
7. Read the test result after 15 minutes. Do not read the result after 20 minutes.
Note: Do not interchange or mix extraction solution from different batches.
Handle the extraction solution with caution, do not touch your eyes or skin. In case of contact with eyes or skin, wash thoroughly with water.
Interpretation of results
1. Positive result
Both the quality control line C and the detection line T are displayed. Any shade of color in the test line (T) region should be considered positive.
If there is suspicion of COVID-19 infection:
- contact your doctor/family doctor or local health facility immediately;
- follow local guidelines for self-isolation;
- perform a confirmatory PCR test.
2. Negative result
Only the quality control line C is displayed, no other lines appear on the detection area.
Continue to follow all applicable rules regarding contact with others and protective measures.
- An infection may be present even if the test is negative.
- If you suspect coronavirus, as it cannot be accurately detected at all stages of an infection, contact your GP/family doctor or local health facility immediately.
3. Invalid result
The quality control line C does not appear, indicating that the test is invalid, regardless of whether the detection line appears or not. Collect a new sample and perform another test with a new device.
- Possibly caused by an incorrect test.
- Repeat the test.
- If your test results are still invalid, contact your doctor/family doctor or local health facility immediately.
Warnings
- SARS-CoV-2 antigen test results should not be used as the sole basis for diagnosing or excluding SARS-CoV-2 infection or for informing about the status of the infection.
- No medical decisions should be made without first consulting your doctor.
- Negative results do not exclude SARS-CoV-2 infection, especially in those who have been in contact with the virus. Follow-up molecular diagnostic testing and/or CT should be considered to rule out infection in these individuals.
- Positive results may be due to a current infection with SARS-coronavirus strains. Follow-up molecular diagnostic testing and/or CT should be considered to confirm the test result.
- Negative results may occur if the antigen level in the specimen is below the detection limit of the test.
- Inaccurate 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 swabs.
- Individuals with color vision problems may not be able to adequately interpret test results.
- For in vitro diagnostic use only, it is for self-testing.
- Keep out of reach of children.
- Use the test device within 60 minutes of opening the foil pouch.
- Do not perform the 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 testing process.
- Please take necessary safety measures (e.g. face mask, gloves) when testing other people.
- The equipment used for the test and all tested components must be disposed of in accordance with local requirements, and can be placed in a well-sealed bag and disposed of as household waste.
- Further molecular diagnostic testing and/or CT is recommended to identify the actual physical situation.
- Do not open the foil pouch of the test device and expose it to the surrounding environment until you are ready to use it immediately.
- Do not use damaged devices or test materials.
- Do not reuse the test device.
- Handle the extraction solution with caution, do not touch your eyes or skin. In case of contact with eyes or skin, wash thoroughly with water.
- Do not use the test kit beyond the expiration date.
- Collect the test sample from the anterior nasal area only. Follow the package insert to obtain accurate results.
- Wash hands thoroughly after handling and wash hands before specimen collection 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 swab, false negative results may occur as a result of poor sampling.
- Failure to follow the test procedure may negatively impact 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 the specified limits may cause inaccurate results. Do not 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 beyond the expiration date.
Validity of intact packaging: 24 months.
Format
1 test, 1 reagent (in sealed tube), 1 measuring cap, 1 tube holder, 1 sterile swab, information leaflet.
Cod. VCD-16-10-013
