Descrizione Clinica
Diagnostics - Sars-cov-2 ag rapid autotest diagnostics
SARS-CoV-2 Antigen Rapid Test
Description
Quick test for the qualitative detection of the SARS-CoV-2 antigen ( nucleocapside protein) that is found in the sample of the nasal cavity (front nose) by individuals with suspected COVID-19 infection. The test kit is intended for autotest or home test.
This test adopts immune side chromatography technology. When the test sample contains SARS-CoV-2, the SARS-CoV-2 antigen will react with the antibody coated on the test line (T) to make a red band appear in the test line area (T); when the content of SARS-CoV-2 in the test sample is too low or does not exist, in the test line area (T) does not appear a red band. Regardless of the fact that the test sample contains the SARS-CoV-2, in the area of the quality control line (C) will appear a red band, which is the basis to judge if the test is effective.
Mode of use
1. Use the ambient temperature test kit (15°C-30°C). if the kit has been previously kept in a cool place (temperature less than 15°C), balance at 15°C-30°C for 30 minutes before the test.
2. Prepare a timer, handkerchiefs, hand disinfectant / soap and hot water.
3. Wash your hands carefully (at least 20 seconds) with soap and hot/hygienizing water for your hands. Then dry your hands.
4. Check the components in the box and check that there is no damage or breakage.
Sample collection:
1. Extract sample extraction tube; unscrew the pipe cap.
2. Place the extraction tube on the bracket (set to the box) to avoid liquid spills.
3. Sprinkle the pack of the pad from the end of the stick and extract the pad.
4. Insert the soft head of the tampon into the nostril less than 1 inch; gently rotate the swab against the nasal wall with moderate force at least five times; use the same swab to repeat the collection procedure in the other nostril.
Sample processing:
1. Extract the extraction tube, immerse the soft head of the tampon in the extraction solution and immerse it in the liquid.
2. Press the soft head of the swab firmly against the inner wall of the extraction tube and rotate the buffer clockwise or anticlockwise about 10 times.
3. Push the swab head along the inner wall of the sample extraction test under the liquid in the test tube as much as possible, extract the swab.
4. Lock the tube cap for standby.
Sample Test:
1. Strap the aluminum envelope, extract the test card and place it horizontally on the test bench.
2. Disconnect the hole cover for the addition of the sample of the extraction tube.
3. Gently squeeze the extraction tube and drop 2 drops of liquid into the test card sample well.
4. Start timekeeping, read the test results at 15 minutes. Do not read before 15 minutes or after 30 minutes.
5. At the end of the test, insert all the materials of the kit into the organic waste bag and dispose of it according to the local policy of disposal of waste at biological risk.
6. Rinse your hands thoroughly for at least 20 seconds with soap and hot/hygienizing water for your hands.
Negative: the quality control line (line C) appears in red band, while the test line (line T) does not appear in red band.
Positive: both the quality control line (line C) and the test line (line T) appear red bands.
Warnings
1. Only for in vitro diagnostic use.
2. To be used with swab samples of the nasal cavity (front recess).
3. Only for protein detection from SARS-CoV-2, not to detect other viruses or pathogenic agents.
4. The person under the age of 18 must be tested with the assistance of the legal guardian or an authorised person.
5. Keep the test kit or kit components out of reach of children and pets before and after use.
6. The test card packaging contains a dryer, it is forbidden to eat.
7. The sample extraction solution in the extraction tube contains chemical components. Direct contact should be avoided and banned. If the solution comes into contact with the skin, mucosa or eyes, rinse with plenty of water. Please contact your family doctor or professional or request medical advice if necessary.
8. It is recommended to use gloves and other protective devices during testing.
9. Test kits must be kept according to the storage conditions required in the instructions for use. It is forbidden to use the test kit that has not been kept as required.
10. Do not use the test kit over the expiry date.
11. Do not use kit components that have been opened or modified.
12. Leave the test card sealed in the aluminum envelope until just before use. Do not use if the envelope is damaged or open.
13. Disposable tampons are sterile products. Do not use if the pad packaging is damaged or open.
14. The use of the tampon must strictly follow the instructions for use; otherwise it can cause nasal cavity bleeding, breakage and buffer retention and other risks.
15. Do not immerse the tampon in the extraction solution or other liquid before collecting the sample with disposable tampons.
16. Do not touch the soft tip of the pad when handling the sample of the pad.
17. The correct collection and manipulation of the sample are fundamental for correct results.
18. Do not mix different batch components.
19. All kit components are disposable items. Do not use with multiple samples. Do not reuse the test kit or the components of the kit used.
20. Before deciding to implement relevant therapeutic or managerial decisions, it is recommended to communicate with family doctors or professionals. Do not take medicines in private or any action that may jeopardize.
21. The components and samples of the test used can be inserted in plastic bags along with normal household waste. If the test result is positive, carefully dispose of waste components and relevant samples and clean and disinfect the working surface to ensure hygiene. If there are special requirements on waste in local laws and regulations, it is necessary to strictly observe them.
22. Do not eat, drink or smoke in the area where samples or test kits are handled.
Conservation
Store between 2 °C and 30°C, in a dry place and protected from direct sunlight (do not freeze the kit or its components).
Validity of whole packaging: 12 months.
Post-opening validation: 60 minutes.
Format
Main components of the kit:
- Test device.
- Extraction pipe.
- Disposable drum.
- Waste bag at biological risk.
- Operating instructions.
Quick test for the qualitative detection of the SARS-CoV-2 antigen ( nucleocapside protein) that is found in the sample of the nasal cavity (front nose) by individuals with suspected COVID-19 infection. The test kit is intended for autotest or home test.
This test adopts immune side chromatography technology. When the test sample contains SARS-CoV-2, the SARS-CoV-2 antigen will react with the antibody coated on the test line (T) to make a red band appear in the test line area (T); when the content of SARS-CoV-2 in the test sample is too low or does not exist, in the test line area (T) does not appear a red band. Regardless of the fact that the test sample contains the SARS-CoV-2, in the area of the quality control line (C) will appear a red band, which is the basis to judge if the test is effective.
Mode of use
1. Use the ambient temperature test kit (15°C-30°C). if the kit has been previously kept in a cool place (temperature less than 15°C), balance at 15°C-30°C for 30 minutes before the test.
2. Prepare a timer, handkerchiefs, hand disinfectant / soap and hot water.
3. Wash your hands carefully (at least 20 seconds) with soap and hot/hygienizing water for your hands. Then dry your hands.
4. Check the components in the box and check that there is no damage or breakage.
Sample collection:
1. Extract sample extraction tube; unscrew the pipe cap.
2. Place the extraction tube on the bracket (set to the box) to avoid liquid spills.
3. Sprinkle the pack of the pad from the end of the stick and extract the pad.
4. Insert the soft head of the tampon into the nostril less than 1 inch; gently rotate the swab against the nasal wall with moderate force at least five times; use the same swab to repeat the collection procedure in the other nostril.
Sample processing:
1. Extract the extraction tube, immerse the soft head of the tampon in the extraction solution and immerse it in the liquid.
2. Press the soft head of the swab firmly against the inner wall of the extraction tube and rotate the buffer clockwise or anticlockwise about 10 times.
3. Push the swab head along the inner wall of the sample extraction test under the liquid in the test tube as much as possible, extract the swab.
4. Lock the tube cap for standby.
Sample Test:
1. Strap the aluminum envelope, extract the test card and place it horizontally on the test bench.
2. Disconnect the hole cover for the addition of the sample of the extraction tube.
3. Gently squeeze the extraction tube and drop 2 drops of liquid into the test card sample well.
4. Start timekeeping, read the test results at 15 minutes. Do not read before 15 minutes or after 30 minutes.
5. At the end of the test, insert all the materials of the kit into the organic waste bag and dispose of it according to the local policy of disposal of waste at biological risk.
6. Rinse your hands thoroughly for at least 20 seconds with soap and hot/hygienizing water for your hands.
Negative: the quality control line (line C) appears in red band, while the test line (line T) does not appear in red band.
Positive: both the quality control line (line C) and the test line (line T) appear red bands.
Warnings
1. Only for in vitro diagnostic use.
2. To be used with swab samples of the nasal cavity (front recess).
3. Only for protein detection from SARS-CoV-2, not to detect other viruses or pathogenic agents.
4. The person under the age of 18 must be tested with the assistance of the legal guardian or an authorised person.
5. Keep the test kit or kit components out of reach of children and pets before and after use.
6. The test card packaging contains a dryer, it is forbidden to eat.
7. The sample extraction solution in the extraction tube contains chemical components. Direct contact should be avoided and banned. If the solution comes into contact with the skin, mucosa or eyes, rinse with plenty of water. Please contact your family doctor or professional or request medical advice if necessary.
8. It is recommended to use gloves and other protective devices during testing.
9. Test kits must be kept according to the storage conditions required in the instructions for use. It is forbidden to use the test kit that has not been kept as required.
10. Do not use the test kit over the expiry date.
11. Do not use kit components that have been opened or modified.
12. Leave the test card sealed in the aluminum envelope until just before use. Do not use if the envelope is damaged or open.
13. Disposable tampons are sterile products. Do not use if the pad packaging is damaged or open.
14. The use of the tampon must strictly follow the instructions for use; otherwise it can cause nasal cavity bleeding, breakage and buffer retention and other risks.
15. Do not immerse the tampon in the extraction solution or other liquid before collecting the sample with disposable tampons.
16. Do not touch the soft tip of the pad when handling the sample of the pad.
17. The correct collection and manipulation of the sample are fundamental for correct results.
18. Do not mix different batch components.
19. All kit components are disposable items. Do not use with multiple samples. Do not reuse the test kit or the components of the kit used.
20. Before deciding to implement relevant therapeutic or managerial decisions, it is recommended to communicate with family doctors or professionals. Do not take medicines in private or any action that may jeopardize.
21. The components and samples of the test used can be inserted in plastic bags along with normal household waste. If the test result is positive, carefully dispose of waste components and relevant samples and clean and disinfect the working surface to ensure hygiene. If there are special requirements on waste in local laws and regulations, it is necessary to strictly observe them.
22. Do not eat, drink or smoke in the area where samples or test kits are handled.
Conservation
Store between 2 °C and 30°C, in a dry place and protected from direct sunlight (do not freeze the kit or its components).
Validity of whole packaging: 12 months.
Post-opening validation: 60 minutes.
Format
Main components of the kit:
- Test device.
- Extraction pipe.
- Disposable drum.
- Waste bag at biological risk.
- Operating instructions.
