Description
SARS-CoV-2 Antigen Rapid Test
(Colloidal Gold)
Description
The SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) is intended for the qualitative detection of SARS-CoV-2 antigen (nucleocapsid protein) found in nasal cavity (anterior nasal) swab specimen from individuals with suspected COVID-19 infection. The test kit is intended for self-testing or home testing.
It adopts immune lateral 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 cause a red band to appear in the test line (T) area; when the content of SARS-CoV-2 in the test sample is too low or non-existent, a red band will not appear in the test line (T) area. Regardless of whether the test sample contains SARS-CoV-2, a red band will appear in the quality control line (C) area, which is the basis for judging whether the test is effective.
How to use
Test procedure
It takes about 15 minutes to prepare before each test and results can be obtained after 30 minutes.
Preparatory work
1. Use the test kit at room temperature (15°C-30°C). If the test kit has been previously stored in a cool place (below 15°C), equilibrate to 15-30°C for 30 minutes before testing.
2. Prepare a timer, tissues, hand sanitizer/soap, and warm water.
3. Wash your hands thoroughly (at least 20 seconds) with soap and warm water/hand sanitizer. This step ensures that the kit does not get contaminated, then dry your hands.
Sample collection
1. Take out the sample extraction tube, unscrew the extraction tube cap.
2. Place the extraction tube on the bracket (fixed to the box) to prevent liquid leakage.
3. Tear the swab packaging from the end of the stick and remove the swab.
4. Clean the nostrils with a swab:
- insert the soft head of the swab into the nostril less than 1 inch (normally about 0.5-0.75 inches);
- 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.
Warning: False negative results may occur if the antigen sample is not collected properly. The person under 18 years of age should be tested with the assistance of a legal guardian or an authorized person.
Sample processing
1. Remove the extraction tube, dip the soft swab head into 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 swab clockwise or counterclockwise approximately 10 times.
3. Push the swab head along the inside wall of the sample extraction tube under the liquid in the tube as far as possible, withdraw the swab.
4. Tighten the standby tube.
Sample Test
1. Tear off the aluminum foil, take out the test card and place it horizontally on the test bench.
Warning: The platform must be in a horizontal and stable state, and tilting and swinging are strictly prohibited.
2. Disconnect the sample addition hole cover of the extraction tube.
3. Gently squeeze the extraction tube and drop 2 drops of liquid vertically into the sample well of the test card.
Warning: The existence of bubbles in the extraction tube may lead to incorrect sample volume and inaccurate test results. If there are bubbles in the extraction tube, gently shake the extraction tube to squeeze out some of the liquid to remove the bubbles.
4. Start timing. Read results after 15 minutes. Do not read before 15 minutes or after 30 minutes.
5. After testing, place all test kit materials into the biohazard waste bag and dispose of according to your local biohazard waste disposal policy.
6. Rinse your hands thoroughly (at least 20 seconds) with soap and warm water/hand sanitizer.
Interpretation of results
Negative: The quality control line (C line) appears in the red band, while the test line (T line) does not appear in the red band.
- It is necessary to continue to adopt measures regarding contact with others and self-protection.
- It is possible that there is an infection, even if the result is negative.
- If still suspected, repeat the test after 1-2 days. Due to coronavirus it cannot be accurately detected at every stage of infection.
Positive: Both the quality control line (C line) and the test line (T line) appear as red bands.
Attention: Regardless of the color shades, within the specified detection time, the result must be considered positive.
- COVID-19 infection is present.
- Contact your doctor or local health department.
- Follow self-quarantine requirements and protection guidelines in your area.
- Perform PCR test for confirmation.
Invalid: Once the red line in the control line region (C line) does not appear, it will be considered invalid.
Warning: Invalid results may indicate that you have not strictly followed the steps in the instructions for use.
-It may be caused by incorrect operation in the detection process.
- Please repeat the test.
- If your test result is still invalid, contact your doctor or COVID-19 testing center.
Warnings
1. For in vitro diagnostic use only.
2. For use with swab specimens from the nasal cavity (anterior nasal).
3. Only for the detection of SARS-CoV-2 proteins, not for the detection of other viruses or pathogens.
4. Persons under the age of 18 must be tested with the assistance of a legal guardian or an authorized person.
5. Keep the test kit or kit components out of the reach of children and pets before and after use.
6. The test paper package contains a desiccant, it is forbidden to eat.
7. The sample extraction solution in the extraction tube contains chemical components. Direct contact should be avoided and eating prohibited. If the solution comes into contact with skin, mucous membranes or eyes, rinse with water. Please contact your GP or professional and seek medical advice if necessary.
8. The use of gloves or other protective devices is recommended when performing tests.
9. It is prohibited to use the test kit that has not been stored as required.
10. Do not use the test kit beyond the expiration date.
11. Do not use any kit components that have been opened or modified.
12. Leave the test card sealed in its foil pouch until immediately before use. Do not use if the pouch is damaged or opened.
13. Disposable swabs are sterile products. Do not use if the swab package is damaged or opened.
14. The use of the swab must strictly follow the instructions for use; otherwise it may cause nasal cavity bleeding, swab breakage and retention or other risks.
15. Do not immerse the swab in the extraction solution or other liquid before collecting the specimen with disposable swabs.
16. Do not touch the soft tip of the swab when handling the swab sample.
17. Correct sample collection and handling are essential for correct results.
18. Do not mix components from different kit lots.
19. All kit components are single-use items. Do not use with multiple specimens. Do not reuse the test kit or used kit components.
20. Before deciding to implement relevant therapeutic or management decisions, it is recommended to communicate with family doctors or professionals. Do not take medicines in private or any action that could endanger yourself or others.
21. Used test kit components and samples can be placed in plastic bags together with normal household waste. If the test result is positive, carefully dispose of the waste components and relevant samples, and thoroughly clean and disinfect the work surface to ensure hygiene.
22. Do not eat, drink, or smoke in the area where specimens or test kits are handled.
Conservation
The test kit should be stored at 2°C-30°C, in a dry place and away from direct sunlight (do not freeze the kit or its components).
The test card must be used within 60 minutes of opening the foil pouch.
Validity of intact packaging: 24 months.
Format
Materials provided:
- 1 test;
- test device;
- extraction tube;
- disposable swab;
- biohazard waste bag;
- instructions for use.
The SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) is intended for the qualitative detection of SARS-CoV-2 antigen (nucleocapsid protein) found in nasal cavity (anterior nasal) swab specimen from individuals with suspected COVID-19 infection. The test kit is intended for self-testing or home testing.
It adopts immune lateral 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 cause a red band to appear in the test line (T) area; when the content of SARS-CoV-2 in the test sample is too low or non-existent, a red band will not appear in the test line (T) area. Regardless of whether the test sample contains SARS-CoV-2, a red band will appear in the quality control line (C) area, which is the basis for judging whether the test is effective.
How to use
Test procedure
It takes about 15 minutes to prepare before each test and results can be obtained after 30 minutes.
Preparatory work
1. Use the test kit at room temperature (15°C-30°C). If the test kit has been previously stored in a cool place (below 15°C), equilibrate to 15-30°C for 30 minutes before testing.
2. Prepare a timer, tissues, hand sanitizer/soap, and warm water.
3. Wash your hands thoroughly (at least 20 seconds) with soap and warm water/hand sanitizer. This step ensures that the kit does not get contaminated, then dry your hands.
Sample collection
1. Take out the sample extraction tube, unscrew the extraction tube cap.
2. Place the extraction tube on the bracket (fixed to the box) to prevent liquid leakage.
3. Tear the swab packaging from the end of the stick and remove the swab.
4. Clean the nostrils with a swab:
- insert the soft head of the swab into the nostril less than 1 inch (normally about 0.5-0.75 inches);
- 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.
Warning: False negative results may occur if the antigen sample is not collected properly. The person under 18 years of age should be tested with the assistance of a legal guardian or an authorized person.
Sample processing
1. Remove the extraction tube, dip the soft swab head into 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 swab clockwise or counterclockwise approximately 10 times.
3. Push the swab head along the inside wall of the sample extraction tube under the liquid in the tube as far as possible, withdraw the swab.
4. Tighten the standby tube.
Sample Test
1. Tear off the aluminum foil, take out the test card and place it horizontally on the test bench.
Warning: The platform must be in a horizontal and stable state, and tilting and swinging are strictly prohibited.
2. Disconnect the sample addition hole cover of the extraction tube.
3. Gently squeeze the extraction tube and drop 2 drops of liquid vertically into the sample well of the test card.
Warning: The existence of bubbles in the extraction tube may lead to incorrect sample volume and inaccurate test results. If there are bubbles in the extraction tube, gently shake the extraction tube to squeeze out some of the liquid to remove the bubbles.
4. Start timing. Read results after 15 minutes. Do not read before 15 minutes or after 30 minutes.
5. After testing, place all test kit materials into the biohazard waste bag and dispose of according to your local biohazard waste disposal policy.
6. Rinse your hands thoroughly (at least 20 seconds) with soap and warm water/hand sanitizer.
Interpretation of results
Negative: The quality control line (C line) appears in the red band, while the test line (T line) does not appear in the red band.
- It is necessary to continue to adopt measures regarding contact with others and self-protection.
- It is possible that there is an infection, even if the result is negative.
- If still suspected, repeat the test after 1-2 days. Due to coronavirus it cannot be accurately detected at every stage of infection.
Positive: Both the quality control line (C line) and the test line (T line) appear as red bands.
Attention: Regardless of the color shades, within the specified detection time, the result must be considered positive.
- COVID-19 infection is present.
- Contact your doctor or local health department.
- Follow self-quarantine requirements and protection guidelines in your area.
- Perform PCR test for confirmation.
Invalid: Once the red line in the control line region (C line) does not appear, it will be considered invalid.
Warning: Invalid results may indicate that you have not strictly followed the steps in the instructions for use.
-It may be caused by incorrect operation in the detection process.
- Please repeat the test.
- If your test result is still invalid, contact your doctor or COVID-19 testing center.
Warnings
1. For in vitro diagnostic use only.
2. For use with swab specimens from the nasal cavity (anterior nasal).
3. Only for the detection of SARS-CoV-2 proteins, not for the detection of other viruses or pathogens.
4. Persons under the age of 18 must be tested with the assistance of a legal guardian or an authorized person.
5. Keep the test kit or kit components out of the reach of children and pets before and after use.
6. The test paper package contains a desiccant, it is forbidden to eat.
7. The sample extraction solution in the extraction tube contains chemical components. Direct contact should be avoided and eating prohibited. If the solution comes into contact with skin, mucous membranes or eyes, rinse with water. Please contact your GP or professional and seek medical advice if necessary.
8. The use of gloves or other protective devices is recommended when performing tests.
9. It is prohibited to use the test kit that has not been stored as required.
10. Do not use the test kit beyond the expiration date.
11. Do not use any kit components that have been opened or modified.
12. Leave the test card sealed in its foil pouch until immediately before use. Do not use if the pouch is damaged or opened.
13. Disposable swabs are sterile products. Do not use if the swab package is damaged or opened.
14. The use of the swab must strictly follow the instructions for use; otherwise it may cause nasal cavity bleeding, swab breakage and retention or other risks.
15. Do not immerse the swab in the extraction solution or other liquid before collecting the specimen with disposable swabs.
16. Do not touch the soft tip of the swab when handling the swab sample.
17. Correct sample collection and handling are essential for correct results.
18. Do not mix components from different kit lots.
19. All kit components are single-use items. Do not use with multiple specimens. Do not reuse the test kit or used kit components.
20. Before deciding to implement relevant therapeutic or management decisions, it is recommended to communicate with family doctors or professionals. Do not take medicines in private or any action that could endanger yourself or others.
21. Used test kit components and samples can be placed in plastic bags together with normal household waste. If the test result is positive, carefully dispose of the waste components and relevant samples, and thoroughly clean and disinfect the work surface to ensure hygiene.
22. Do not eat, drink, or smoke in the area where specimens or test kits are handled.
Conservation
The test kit should be stored at 2°C-30°C, in a dry place and away from direct sunlight (do not freeze the kit or its components).
The test card must be used within 60 minutes of opening the foil pouch.
Validity of intact packaging: 24 months.
Format
Materials provided:
- 1 test;
- test device;
- extraction tube;
- disposable swab;
- biohazard waste bag;
- instructions for use.
