Description
The SARS-CoV-2 Rapid Antigen Test (Colloidal Gold) is intended for the qualitative detection of SARS-CoV-2 antigen (nucleocapsid protein) in nasal cavity (anterior nasal) swab specimens from individuals suspected of having COVID-19. The test kit is intended for self-testing or at-home testing.
It uses 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), causing a red band to appear in the test line (T) region. When the SARS-CoV-2 content in the test sample is too low or nonexistent, a red band will not appear in the test line (T). Regardless of whether the test sample contains SARS-CoV-2, a red band will appear in the quality control line (C) region, which is the basis for judging the effectiveness of the test.

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 previously been 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 hot water.
3. Wash your hands thoroughly (at least 20 seconds) with soap and warm water/hand sanitizer. This step ensures the kit is not 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 correctly. Anyone under 18 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 inside wall of the extraction tube and rotate the swab clockwise or counterclockwise approximately 10 times.
3. Push the head of the swab 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 foil bag, 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: Bubbles in the extraction tube may result in incorrect sample volume and inaccurate test results. If bubbles are present in the extraction tube, gently shake the extraction tube to squeeze out some of the liquid and remove the bubbles.
4. Start timing. Read the results after 15 minutes. Do not read before 15 minutes or after 30 minutes.
5. Upon completion of the test, place all test kit materials into the biohazard waste bag and dispose of it 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 the 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 you still suspect the infection, repeat the test after 1-2 days. Due to the 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.
Caution: 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 did not strictly follow 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 the 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. For the detection of SARS-CoV-2 proteins only, not for the detection of other viruses or pathogens.
4. Persons under 18 years of age 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, do not eat.
7. The sample extraction solution in the extraction tube contains chemicals. Direct contact should be avoided, and eating is prohibited. If the solution comes into contact with skin, mucous membranes, or eyes, rinse with water. Please contact your GP or healthcare professional and seek medical advice if necessary.
8. The use of gloves or other protective devices is recommended when performing the 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 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. Use of the swab must strictly follow the instructions for use; otherwise, it may cause nasal bleeding, breakage and retention of the swab, 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 accurate 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 making any significant therapeutic or management decisions, it is recommended to consult with your family doctor or other professionals. Avoid taking medications in private or engaging in any action that could endanger yourself or others.
21. Used test kit components and samples can be placed in plastic bags 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 samples 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.
Shelf life of intact packaging: 24 months.

Format
Materials provided:
- 1 test;
- test device;
- extraction pipe;
- disposable swab;
- biohazard waste bag;
- instructions for use.