Description
VivaDiag Pro
SARS-COV-2 AG RAPID TEST
Description
Rapid test for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in nasal swab samples. It is a self-test. It provides only an initial screening test result. To confirm SARS-CoV-2 infection, it is necessary to use more specific alternative diagnostic methods (molecular diagnostics and/or CT). It is up to the doctor to decide which diagnostic procedure to follow.
This test is intended for home use and is performed by means of a nasal swab taken directly by users aged between 16 and 69 years. Persons under 16 years of age or over 69 years of age must be assisted during sample collection and must perform the test under the supervision of an adult. In the case of persons who are unable to perform the test independently, the test must be performed by the legal guardian. Persons with disabilities (including persons with impaired color vision) must be assisted during the test.
How to use
1. Sample collection
- Anterior nasal swab sample
Wash your hands with soap and water or use hand sanitizer. It is important to collect as much secretion as possible. Open the swab package at the end of the stick and remove 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 along the inside lining of the nostril to ensure that both mucus and cells are collected. Repeat the process in the other nostril to ensure that an adequate amount of sample is collected from both nasal cavities (use the same swab).
2. Using the sample
After collecting the sample, the test should be performed as soon as possible (it is recommended to perform the test within 5 minutes).
Procedure for carrying out the test
Before performing the test, allow the test devices and the extraction solution to reach a temperature of 15°-30°C. 1. Open the extraction solution (in the sealed tube).
2. For sample collection see Sample Collection section.
3. Insert the swab with the collected sample into the tube filled with extraction solution. Rotate the swab 5 times by pressing its head against the bottom and side of the extraction tube. Remove the swab by pressing it against the sides of the tube to extract the liquid. Try to get as much liquid out as possible. Dispose of the used swab in biohazard waste.
4. Close the test tube with the appropriate tip.
5. Remove a test device from the sealed foil pouch and place it on a clean, level surface.
6. Apply 3 drops (approximately 60 mcl) of collected sample into the sample well. Avoid bubbles when applying the sample.
7. Wait 15 minutes and read the test result. Do not read the result after 20 minutes.
Interpretation of results
Positive result:
both the quality control line C and the detection line T appear. Any shade of color in the test line area (T) should be considered as a positive result.
- There is a current suspicion of COVID-19 infection.
- Contact your family doctor or local health district immediately.
- Follow local self-isolation guidelines.
- Perform a confirmatory PCR test.
- If you suspect any infection, contact your GP or local health district immediately.
Negative result:
Only the quality control line C appears, with no other lines on the detection line.
- Continue to follow all applicable rules regarding contact with other people and protective measures.
- You may have an infection even if your test result is negative.
- Since it is not possible to accurately detect coronavirus at all stages of infection, if you suspect an infection, contact your GP or local health district immediately.
Invalid result:
Failure to display the quality control line C indicates that the test is invalid, regardless of whether the detection line appears or not.
- This may occur if the test is not performed correctly. - Repeat the test. - If the test results are still invalid, contact your GP or local health district 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 obtaining information on infection status.
You should consult your doctor before making any clinical decisions.
Negative results do not rule out SARS-CoV-2 infection, especially in those who have been in contact with the virus. Follow-up testing with molecular diagnostics and/or CT should be considered to rule out infection in these individuals.
Any positive results may be caused by the presence of an infection with SARS-coronavirus strains; for further details, see the “Cross-reactivity” section. To confirm the test result, a follow-up test with molecular diagnostics and/or CT is required.
If the antigen level in the sample is below the detection limit of the test, negative results may occur.
Inaccurate results may occur if the sample is too viscous or contains visible traces of blood, if the sample is too small or if bubbles form during sample application.
Do not use the swab if it appears damaged or unusable.
People with impaired color vision may not be able to interpret the test results correctly.
For in vitro diagnostic use only. Self-test.
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 testing device if it has been in contact with household cleaning products (especially bleach).
Avoid allowing foreign substances to come into contact with the test device while performing the test.
Take necessary safety measures (e.g. mask, gloves) if testing other people.
The device and all components used during the test must be disposed of in accordance with local regulations and can be placed in a well-sealed bag and disposed of as household waste.
Further molecular diagnostics and/or CT are recommended to identify the actual physical situation.
Do not open the foil pouch containing the test device until you are ready to use it, to avoid exposing it to the surrounding environment.
Never use devices or other test materials that show signs of damage.
Do not reuse the same device for testing.
Handle the extraction solution with care, avoiding contact with eyes or skin. In case of accidental spillage on eyes or skin, wash the area thoroughly with water.
Do not use the test kit beyond the expiration date.
Use only nasal swabs as a sample. To obtain accurate results, it is necessary to follow the instructions in the package insert.
Wash your hands thoroughly after handling the test.
This test does not establish 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 swab sample. False negative results may be caused by insufficient sample volume.
Failure to follow the test procedure may adversely affect the performance of the test and/or invalidate the test result.
Conservation
Store the test kit in a cool, dry place between 2°C and 30°C. Protect from light. Exposure to temperatures and/or humidity outside the specified conditions may cause inaccurate results. Do not freeze or refrigerate. Use the test kit between 15°C and 30°C.
Use the test kit in humidity conditions between 10%-90%.
Do not use the test kit beyond the expiration date (printed on the foil pouch and box).
Cod. VCD16-10-013
Rapid test for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in nasal swab samples. It is a self-test. It provides only an initial screening test result. To confirm SARS-CoV-2 infection, it is necessary to use more specific alternative diagnostic methods (molecular diagnostics and/or CT). It is up to the doctor to decide which diagnostic procedure to follow.
This test is intended for home use and is performed by means of a nasal swab taken directly by users aged between 16 and 69 years. Persons under 16 years of age or over 69 years of age must be assisted during sample collection and must perform the test under the supervision of an adult. In the case of persons who are unable to perform the test independently, the test must be performed by the legal guardian. Persons with disabilities (including persons with impaired color vision) must be assisted during the test.
How to use
1. Sample collection
- Anterior nasal swab sample
Wash your hands with soap and water or use hand sanitizer. It is important to collect as much secretion as possible. Open the swab package at the end of the stick and remove 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 along the inside lining of the nostril to ensure that both mucus and cells are collected. Repeat the process in the other nostril to ensure that an adequate amount of sample is collected from both nasal cavities (use the same swab).
2. Using the sample
After collecting the sample, the test should be performed as soon as possible (it is recommended to perform the test within 5 minutes).
Procedure for carrying out the test
Before performing the test, allow the test devices and the extraction solution to reach a temperature of 15°-30°C. 1. Open the extraction solution (in the sealed tube).
2. For sample collection see Sample Collection section.
3. Insert the swab with the collected sample into the tube filled with extraction solution. Rotate the swab 5 times by pressing its head against the bottom and side of the extraction tube. Remove the swab by pressing it against the sides of the tube to extract the liquid. Try to get as much liquid out as possible. Dispose of the used swab in biohazard waste.
4. Close the test tube with the appropriate tip.
5. Remove a test device from the sealed foil pouch and place it on a clean, level surface.
6. Apply 3 drops (approximately 60 mcl) of collected sample into the sample well. Avoid bubbles when applying the sample.
7. Wait 15 minutes and read the test result. Do not read the result after 20 minutes.
Interpretation of results
Positive result:
both the quality control line C and the detection line T appear. Any shade of color in the test line area (T) should be considered as a positive result.
- There is a current suspicion of COVID-19 infection.
- Contact your family doctor or local health district immediately.
- Follow local self-isolation guidelines.
- Perform a confirmatory PCR test.
- If you suspect any infection, contact your GP or local health district immediately.
Negative result:
Only the quality control line C appears, with no other lines on the detection line.
- Continue to follow all applicable rules regarding contact with other people and protective measures.
- You may have an infection even if your test result is negative.
- Since it is not possible to accurately detect coronavirus at all stages of infection, if you suspect an infection, contact your GP or local health district immediately.
Invalid result:
Failure to display the quality control line C indicates that the test is invalid, regardless of whether the detection line appears or not.
- This may occur if the test is not performed correctly. - Repeat the test. - If the test results are still invalid, contact your GP or local health district 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 obtaining information on infection status.
You should consult your doctor before making any clinical decisions.
Negative results do not rule out SARS-CoV-2 infection, especially in those who have been in contact with the virus. Follow-up testing with molecular diagnostics and/or CT should be considered to rule out infection in these individuals.
Any positive results may be caused by the presence of an infection with SARS-coronavirus strains; for further details, see the “Cross-reactivity” section. To confirm the test result, a follow-up test with molecular diagnostics and/or CT is required.
If the antigen level in the sample is below the detection limit of the test, negative results may occur.
Inaccurate results may occur if the sample is too viscous or contains visible traces of blood, if the sample is too small or if bubbles form during sample application.
Do not use the swab if it appears damaged or unusable.
People with impaired color vision may not be able to interpret the test results correctly.
For in vitro diagnostic use only. Self-test.
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 testing device if it has been in contact with household cleaning products (especially bleach).
Avoid allowing foreign substances to come into contact with the test device while performing the test.
Take necessary safety measures (e.g. mask, gloves) if testing other people.
The device and all components used during the test must be disposed of in accordance with local regulations and can be placed in a well-sealed bag and disposed of as household waste.
Further molecular diagnostics and/or CT are recommended to identify the actual physical situation.
Do not open the foil pouch containing the test device until you are ready to use it, to avoid exposing it to the surrounding environment.
Never use devices or other test materials that show signs of damage.
Do not reuse the same device for testing.
Handle the extraction solution with care, avoiding contact with eyes or skin. In case of accidental spillage on eyes or skin, wash the area thoroughly with water.
Do not use the test kit beyond the expiration date.
Use only nasal swabs as a sample. To obtain accurate results, it is necessary to follow the instructions in the package insert.
Wash your hands thoroughly after handling the test.
This test does not establish 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 swab sample. False negative results may be caused by insufficient sample volume.
Failure to follow the test procedure may adversely affect the performance of the test and/or invalidate the test result.
Conservation
Store the test kit in a cool, dry place between 2°C and 30°C. Protect from light. Exposure to temperatures and/or humidity outside the specified conditions may cause inaccurate results. Do not freeze or refrigerate. Use the test kit between 15°C and 30°C.
Use the test kit in humidity conditions between 10%-90%.
Do not use the test kit beyond the expiration date (printed on the foil pouch and box).
Cod. VCD16-10-013
