Descrizione Clinica
Antigen Test Kit
Description
Test of rapid antigen ( colloidal gold).
Only for in vitro diagnostic use.
The product is used for the qualitative detection of SARS-CoV-2 antigen in human nasal swab sample. It is designed for domestic use as a quick test method for coronavirus infection.
It is indicated for users aged 15 years. Users under 15 years must be tested with the assistance of an adult. Both symptomatic and asymptomatic information can be detected.
Mode of use
Test preparation
Blow your nose a few times before collecting the sample. Clean your hands and make sure they are dry before starting the test.
Read the instructions carefully.
Check all parts of the test kit to ensure that all parts are complete and undamaged.
Check the printed expiration date on the aluminum bag of the test device.
Test procedure
1. Open the packaging and extract the device. Know the observation window and the sampling well (S). To use within an hour.
2. Unscrew the extraction tube cover counterclockwise.
3. Press the perforated circle in advance, make a hole in the outer box, and then insert the bottom of the antigen extraction tube into the hole.
4. Remove the sterilized tampon from the packaging.
5. Relax your head naturally. Carefully insert the tampon into the nostril, the tip of the pad must be inserted up to 2 cm, where resistance meets.
6. Rotate the swab firmly inside the nostril, making 5 full turns. With the same swab, repeat the process for the other nostril to ensure that an adequate quantity of sample is collected.
7. Extract the swab from the nasal cavity.
8. Insert the swab sample into the extraction tube, turn the buffer for about 10 seconds, then press the swab head against the pipe walls 3 times to release the antigen into the buffer.
9. Screw the extraction tube cover clockwise.
10. Avoid the small white cover at the top of the extraction tube.
11. Keep the extraction tube vertically and add two test sample drops in the sampling well (S). Start the timer.
12. Read results 15 minutes later. Do not read the result after 30 minutes.
13. Put all the materials used in the closed collection bag for proper disposal. The test kit is disposed of as normal household waste in accordance with applicable local regulations.
Interpretation of test results
Negative result
If there is only one control line (C) and the test line (T) is colorless, this indicates that the SARS-Co-V-2 antigen was not detected and the result is negative.
If the test result is negative: continue to comply with all applicable rules regarding contact with others and protective measures. Even if the test is negative, there may be an infection. In case of doubt, repeat the test after 1-2 days, as the coronavirus cannot be detected precisely in all stages of the infection.
Positive result
If the control line (C) and the test line (T), this indicates that the SARS-CoV-2 antigen was detected and the result is positive.
If the test result is positive: there is a suspected COVID-19 infection; immediately contact your doctor or local health department, comply with local guidelines on self-isolation, run the PCR test for confirmation.
Disability result
If the control line (C) is not observed, the test is deemed invalid regardless of whether the test line (T) is visible or not. You must run a new test using a new test device.
If the test result is invalid, this may have been caused by incorrect testing. Repeat the test. If the test result remains invalid, contact your doctor or COVID-19 test center.
Warnings
- Carefully read the instructions before using the kit, and carefully check the reaction time. If you do not follow the instructions, you will get unexpected results.
- Protect from moisture, do not open the aluminum bag before it is ready for testing. Do not use the test device if the aluminum bag is damaged.
- Use by the deadline.
- Balance all reagents and samples at room temperature (15 °C-30 °C) before use.
- Don't replace the components in this kit with those from another kit.
- Do not dilute the sample during the test, otherwise you will get imprecise results.
- The kit must be kept strictly in accordance with the specified conditions. Do not store the kit in frost conditions.
- Test methods and results must be interpreted in strict accordance with this specification.
- Negative results would be possible if the SARS-CoV-2 antigen title in the sample was below the minimum detection limit of this kit.
Conservation
Store at 4 °C-30 °C for 24 months.
After opening the aluminum bag, the test device must be used as soon as possible and within an hour (15 °C-30 °C, humidity Fresh samples collected must be processed as soon as possible. They must be treated within an hour of the collection. Samples processed can be stored at 2 °C -8 °C for no more than 24 hours.
Format
Test device, instructions, antigen extraction tube, sterilized buffer.
Cod. DPCOVAG
Test of rapid antigen ( colloidal gold).
Only for in vitro diagnostic use.
The product is used for the qualitative detection of SARS-CoV-2 antigen in human nasal swab sample. It is designed for domestic use as a quick test method for coronavirus infection.
It is indicated for users aged 15 years. Users under 15 years must be tested with the assistance of an adult. Both symptomatic and asymptomatic information can be detected.
Mode of use
Test preparation
Blow your nose a few times before collecting the sample. Clean your hands and make sure they are dry before starting the test.
Read the instructions carefully.
Check all parts of the test kit to ensure that all parts are complete and undamaged.
Check the printed expiration date on the aluminum bag of the test device.
Test procedure
1. Open the packaging and extract the device. Know the observation window and the sampling well (S). To use within an hour.
2. Unscrew the extraction tube cover counterclockwise.
3. Press the perforated circle in advance, make a hole in the outer box, and then insert the bottom of the antigen extraction tube into the hole.
4. Remove the sterilized tampon from the packaging.
5. Relax your head naturally. Carefully insert the tampon into the nostril, the tip of the pad must be inserted up to 2 cm, where resistance meets.
6. Rotate the swab firmly inside the nostril, making 5 full turns. With the same swab, repeat the process for the other nostril to ensure that an adequate quantity of sample is collected.
7. Extract the swab from the nasal cavity.
8. Insert the swab sample into the extraction tube, turn the buffer for about 10 seconds, then press the swab head against the pipe walls 3 times to release the antigen into the buffer.
9. Screw the extraction tube cover clockwise.
10. Avoid the small white cover at the top of the extraction tube.
11. Keep the extraction tube vertically and add two test sample drops in the sampling well (S). Start the timer.
12. Read results 15 minutes later. Do not read the result after 30 minutes.
13. Put all the materials used in the closed collection bag for proper disposal. The test kit is disposed of as normal household waste in accordance with applicable local regulations.
Interpretation of test results
Negative result
If there is only one control line (C) and the test line (T) is colorless, this indicates that the SARS-Co-V-2 antigen was not detected and the result is negative.
If the test result is negative: continue to comply with all applicable rules regarding contact with others and protective measures. Even if the test is negative, there may be an infection. In case of doubt, repeat the test after 1-2 days, as the coronavirus cannot be detected precisely in all stages of the infection.
Positive result
If the control line (C) and the test line (T), this indicates that the SARS-CoV-2 antigen was detected and the result is positive.
If the test result is positive: there is a suspected COVID-19 infection; immediately contact your doctor or local health department, comply with local guidelines on self-isolation, run the PCR test for confirmation.
Disability result
If the control line (C) is not observed, the test is deemed invalid regardless of whether the test line (T) is visible or not. You must run a new test using a new test device.
If the test result is invalid, this may have been caused by incorrect testing. Repeat the test. If the test result remains invalid, contact your doctor or COVID-19 test center.
Warnings
- Carefully read the instructions before using the kit, and carefully check the reaction time. If you do not follow the instructions, you will get unexpected results.
- Protect from moisture, do not open the aluminum bag before it is ready for testing. Do not use the test device if the aluminum bag is damaged.
- Use by the deadline.
- Balance all reagents and samples at room temperature (15 °C-30 °C) before use.
- Don't replace the components in this kit with those from another kit.
- Do not dilute the sample during the test, otherwise you will get imprecise results.
- The kit must be kept strictly in accordance with the specified conditions. Do not store the kit in frost conditions.
- Test methods and results must be interpreted in strict accordance with this specification.
- Negative results would be possible if the SARS-CoV-2 antigen title in the sample was below the minimum detection limit of this kit.
Conservation
Store at 4 °C-30 °C for 24 months.
After opening the aluminum bag, the test device must be used as soon as possible and within an hour (15 °C-30 °C, humidity Fresh samples collected must be processed as soon as possible. They must be treated within an hour of the collection. Samples processed can be stored at 2 °C -8 °C for no more than 24 hours.
Format
Test device, instructions, antigen extraction tube, sterilized buffer.
Cod. DPCOVAG
