Descrizione Clinica
Fast Nasal Test.
VivaDiag Pro
TEST RAPIDO SARS-COV-2 AG
Description
Quick test for quality detection of nucleocapside protein antigen from SARS-CoV-2 in nasal swab samples. It's a self-diagnostic test. It only provides an initial result of the screening test. To confirm SARS-CoV-2 infection, you need to use more specific alternative diagnostic methods (molecular diagnostics and/or TC). It is up to the doctor to decide the diagnostic procedure to follow.
This test is intended for domestic use and is performed by nasal swab directly by users aged 16 to 69. Persons under 16 or over 69 years of age must be assisted during the sample collection and under the supervision of an adult. In case of people who are unable to carry out the test independently, the test must be performed by the legal guardian. Disabled people (including people with color perception alteration) must be assisted during the test.
Mode of use
1. Sample collection
- Front nasal swab sample
Wash your hands with soap and water or use a disinfectant for your hands. It is important to collect as much secretion as possible. Open the pack of the pad from the end of the stick and extract the pad. Insert the sterile tampon into a nostril. Make sure the entire tip of the pad is inserted in the nostril (about 1.5 cm). Rotate the swab 5 times along the inner mucosa of the nostril to be sure to collect both mucus and cells. Repeat the process in the other nostril, so as to ensure the collection of an adequate quantity of sample from both nasal cavities (use the same swab).
2. Sample use
After collecting the sample you must perform the test as soon as possible (it is recommended to run the test within 5 minutes).
Test procedure
Before testing, wait for the test and extraction solution to reach the temperature of 15°-30°C. 1. Open the extraction solution (in the sealed tube).
2. For sample collection see the Sample Collection section.
3. Insert the swab with the sample collected in the test piece full of extraction solution. Turn the swab 5 times by pressing the head against the bottom and side of the extraction test. Remove the pad by pressing it against the sides of the tube to extract the liquid. Try to get as liquid as possible. Dispose of the buffer used in biologically hazardous waste.
4. Close the test tube with the tip.
5. Extract a test device from the sealed aluminum sachet and place it on a clean and leveled surface.
6. Apply 3 drops (about 60 mcl) of sample collected in the sample well. Avoid boiling during sample application.
7. Wait 15 minutes and read the test result. Do not read the result after 20 minutes have passed.
Interpretation of results
Positive result:
both the C quality control line and the T detection line appear. A possible color shade in the test line area (T) must be considered as a positive result.
- There is a current suspicion of a COVID-19 infection.
- Contact your family doctor or local health district immediately.
- Follow the local guidelines on self-isolation.
- Make a PCR test.
- If you suspect an infection, please contact your family doctor or local health district immediately.
Negative result:
only the C quality control line appears, without any other line on the detection line.
- Continue to follow all applicable rules regarding contact with other persons and protection measures.
- It is possible that an infection is ongoing even if the result of the test is negative.
- Since it is not possible to accurately detect the coronavirus in all stages of the infection, in case you suspect an infection immediately contact your family doctor or local health district.
Result not valid:
the failure of the C quality control line indicates that the test is not valid, regardless of whether or not the detection line appears.
- It may occur if the test is not performed properly. - If the test results are still invalid, please contact your family doctor or local health district immediately.
Warnings
The results of antigenic tests for SARS-CoV-2 must not be used as the sole basis for the diagnosis or exclusion of an SARS-CoV-2 infection or for the acquisition of information on the state of the infection.
You must consult your physician before making clinical decisions.
Negative results do not exclude SARS-CoV-2 infection, especially in those who have been in contact with the virus. Follow-up tests with molecular diagnostics and/or TC must be taken into consideration to exclude infection in these individuals.
Any positive results can be caused by the presence of a SARS-coronavirus strain infection; for further details, please refer to the section “Reactivity crusade”. To confirm the test result, a follow-up test with molecular diagnostics and/or TC is required.
If the antigen level in the sample is lower than the test detection limit negative results may occur.
Imprecise results may occur in case of excessively viscous sample or with visible traces of blood, insufficient sample volume or bubble formation during sample application.
Do not use the buffer if it appears damaged or is not usable.
People with color perception alteration may not be able to correctly interpret the test results.
Only for in vitro diagnostic use. Self-diagnostic test.
Keep out of reach of children.
Use the test device within 60 minutes from the opening of the aluminum bag.
Do not test in direct sunlight.
Do not use the test device if you have been in contact with house cleaning products (especially bleach).
Prevent foreign substances from contacting the test device during testing.
Adopt the necessary safety measures (e.g. mask, gloves) if you test for other people.
The device and all components used during the test must be disposed of in accordance with local regulations and can be stored in a well sealed bag and disposed of as domestic waste.
Further molecular and/or TC diagnostics are recommended to identify the actual physical situation.
Do not open the aluminum envelope that contains the test device until it is used, so as to avoid exposure to the surrounding environment.
Never use devices or other analysis materials that show signs of damage.
Do not reuse the same device for the test.
Carefully handle the extraction solution, avoiding contact with eyes or skin. In case of accidental pouring on eyes or skin, thoroughly wash the area with water.
Do not use the test kit over the expiry date.
Use only nasal swabs as sample. To obtain accurate results it is necessary to follow the indications given in the leaflet.
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. Any false negative results can be caused by an insufficient volume of the sample.
Failure to comply with the test procedure may negatively affect the test performance and/or invalidate the result.
Conservation
Store the test kit in a cool and dry place, at a temperature between 2 °C and 30 °C. Exposure to a temperature and/or humidity level that does not fall within the specified conditions can lead to unexpected results. Do not freeze or store in the refrigerator. Use the temperature test kit between 15 °C and 30 °C.
Use the test kit with a humidity rate between 10%-90%.
Do not use the test kit over the expiry date (printed on the aluminum bag and the box).
Cod. VCD16-10-013
Quick test for quality detection of nucleocapside protein antigen from SARS-CoV-2 in nasal swab samples. It's a self-diagnostic test. It only provides an initial result of the screening test. To confirm SARS-CoV-2 infection, you need to use more specific alternative diagnostic methods (molecular diagnostics and/or TC). It is up to the doctor to decide the diagnostic procedure to follow.
This test is intended for domestic use and is performed by nasal swab directly by users aged 16 to 69. Persons under 16 or over 69 years of age must be assisted during the sample collection and under the supervision of an adult. In case of people who are unable to carry out the test independently, the test must be performed by the legal guardian. Disabled people (including people with color perception alteration) must be assisted during the test.
Mode of use
1. Sample collection
- Front nasal swab sample
Wash your hands with soap and water or use a disinfectant for your hands. It is important to collect as much secretion as possible. Open the pack of the pad from the end of the stick and extract the pad. Insert the sterile tampon into a nostril. Make sure the entire tip of the pad is inserted in the nostril (about 1.5 cm). Rotate the swab 5 times along the inner mucosa of the nostril to be sure to collect both mucus and cells. Repeat the process in the other nostril, so as to ensure the collection of an adequate quantity of sample from both nasal cavities (use the same swab).
2. Sample use
After collecting the sample you must perform the test as soon as possible (it is recommended to run the test within 5 minutes).
Test procedure
Before testing, wait for the test and extraction solution to reach the temperature of 15°-30°C. 1. Open the extraction solution (in the sealed tube).
2. For sample collection see the Sample Collection section.
3. Insert the swab with the sample collected in the test piece full of extraction solution. Turn the swab 5 times by pressing the head against the bottom and side of the extraction test. Remove the pad by pressing it against the sides of the tube to extract the liquid. Try to get as liquid as possible. Dispose of the buffer used in biologically hazardous waste.
4. Close the test tube with the tip.
5. Extract a test device from the sealed aluminum sachet and place it on a clean and leveled surface.
6. Apply 3 drops (about 60 mcl) of sample collected in the sample well. Avoid boiling during sample application.
7. Wait 15 minutes and read the test result. Do not read the result after 20 minutes have passed.
Interpretation of results
Positive result:
both the C quality control line and the T detection line appear. A possible color shade in the test line area (T) must be considered as a positive result.
- There is a current suspicion of a COVID-19 infection.
- Contact your family doctor or local health district immediately.
- Follow the local guidelines on self-isolation.
- Make a PCR test.
- If you suspect an infection, please contact your family doctor or local health district immediately.
Negative result:
only the C quality control line appears, without any other line on the detection line.
- Continue to follow all applicable rules regarding contact with other persons and protection measures.
- It is possible that an infection is ongoing even if the result of the test is negative.
- Since it is not possible to accurately detect the coronavirus in all stages of the infection, in case you suspect an infection immediately contact your family doctor or local health district.
Result not valid:
the failure of the C quality control line indicates that the test is not valid, regardless of whether or not the detection line appears.
- It may occur if the test is not performed properly. - If the test results are still invalid, please contact your family doctor or local health district immediately.
Warnings
The results of antigenic tests for SARS-CoV-2 must not be used as the sole basis for the diagnosis or exclusion of an SARS-CoV-2 infection or for the acquisition of information on the state of the infection.
You must consult your physician before making clinical decisions.
Negative results do not exclude SARS-CoV-2 infection, especially in those who have been in contact with the virus. Follow-up tests with molecular diagnostics and/or TC must be taken into consideration to exclude infection in these individuals.
Any positive results can be caused by the presence of a SARS-coronavirus strain infection; for further details, please refer to the section “Reactivity crusade”. To confirm the test result, a follow-up test with molecular diagnostics and/or TC is required.
If the antigen level in the sample is lower than the test detection limit negative results may occur.
Imprecise results may occur in case of excessively viscous sample or with visible traces of blood, insufficient sample volume or bubble formation during sample application.
Do not use the buffer if it appears damaged or is not usable.
People with color perception alteration may not be able to correctly interpret the test results.
Only for in vitro diagnostic use. Self-diagnostic test.
Keep out of reach of children.
Use the test device within 60 minutes from the opening of the aluminum bag.
Do not test in direct sunlight.
Do not use the test device if you have been in contact with house cleaning products (especially bleach).
Prevent foreign substances from contacting the test device during testing.
Adopt the necessary safety measures (e.g. mask, gloves) if you test for other people.
The device and all components used during the test must be disposed of in accordance with local regulations and can be stored in a well sealed bag and disposed of as domestic waste.
Further molecular and/or TC diagnostics are recommended to identify the actual physical situation.
Do not open the aluminum envelope that contains the test device until it is used, so as to avoid exposure to the surrounding environment.
Never use devices or other analysis materials that show signs of damage.
Do not reuse the same device for the test.
Carefully handle the extraction solution, avoiding contact with eyes or skin. In case of accidental pouring on eyes or skin, thoroughly wash the area with water.
Do not use the test kit over the expiry date.
Use only nasal swabs as sample. To obtain accurate results it is necessary to follow the indications given in the leaflet.
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. Any false negative results can be caused by an insufficient volume of the sample.
Failure to comply with the test procedure may negatively affect the test performance and/or invalidate the result.
Conservation
Store the test kit in a cool and dry place, at a temperature between 2 °C and 30 °C. Exposure to a temperature and/or humidity level that does not fall within the specified conditions can lead to unexpected results. Do not freeze or store in the refrigerator. Use the temperature test kit between 15 °C and 30 °C.
Use the test kit with a humidity rate between 10%-90%.
Do not use the test kit over the expiry date (printed on the aluminum bag and the box).
Cod. VCD16-10-013
