Description
The SARS-CoV-2 (colloidal gold) antigen rapid test is intended for the qualitative detection of SARS-CoV-2 antigen (nucleocapsid protein) found in the nasal cavity (anterior nasal) buffer sample from individuals with suspected COVID-19 infection. The test kit is intended for self-testing or home testing.
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 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) A red band does not appear. Regardless of whether the test sample contains the SARS-CoV-2, a red band will appear in the area of the quality control line (C), 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 the 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 (temperature below 15 °C), balance at 15-30 °C for 30 minutes before the test.
2. Prepare a timer, tissues, hand sanitizer/soap and hot water.
3. Wash hands thoroughly (at least 20 seconds) with soap and warm water/hand sanitizer. This step ensures that the kit does not get contaminated, so dry your hands.

Collection of samples
1. Pull out the sample extraction tube, unscrew the extraction tube cap.
2. Place the extraction tube on the bracket (attached to the box) to prevent liquid outputs.
3. Tear off the pad packaging from the end of the stick and pull out the tampon.
4. Clean the nostrils with a tampon:
-Insert the soft head of the tampon into the nostril at less than 1 inch (normally about 0.5-0.75 inches);
-Gently rotate the tampon against the nasal wall with moderate force at least five times;
-Use the same tampon 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 the age of 18 should be tested with the assistance of the legal guardian or a licensed person.

Sample Processing
1. Pull out the extraction tube, immerse the soft swab head in the extraction solution and immerse it in the liquid.
2. Press the soft head of the pad firmly against the inner wall of the extraction tube and rotate the buffer clockwise or counterclockwise for about 10 times.
3. Push the tampon head along the inner wall of the sample extraction tube under the liquid in the test tube as much as possible, pull out the pad.
4. Tighten the tube for standby.

Sample test
1. Tear off the aluminum bag, pull out the test card and place it horizontally on the test bench.
Warning: The platform must be in a horizontal and stable state, and the tilt and swing are strictly prohibited.
2. Disconnect the hole cover for the sample addition 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 can 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 so that the bubbles are removed.
4. Starting to time. Read the results after 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 test kit into the biohazard waste bag and dispose of it according to the local biohazard waste disposal policy.
6. Rinse hands thoroughly (at least 20 seconds) with soap and warm water/hand sanitizer.

Interpretation of results
Negative: The quality control line (line C) appears in red band, while the test line (line T) does not appear in red band.
-It is necessary to continue to take measures related to contact with others and self-protection.
-It is possible that there is an infection, even if the result is negative.
-If it is still suspected, repeat the test after 1-2 days. Because of the coronavirus cannot be accurately detected at every stage of infection.
Positive: Both the quality control line (line C) and the test line (line T) appear red bands.
Attention: regardless of color shades, within the specified detection time, the results should be considered positive.
-COVID-19 infection is present.
-- Contact your local doctor or health department.
-- Comply with self-quarantine requirements and protection guidelines in your area.
-Perform the PCR test for confirmation.
Invalid: Once the red line in the control line region (line C) does not appear, it will be considered invalid.
Warning: Invalid results may indicate that you have not strictly followed the steps of the instructions for use.
-It could be caused by an incorrect operation in the detection process.
-Please repeat the test.
-If the test result is still not valid, contact your doctor or COVID-19 test center.

Warnings
1. For in vitro diagnostic use only.
2. For use with swab samples in the nasal cavity (anterior nasal).
3. Only for detection of SARS-CoV-2 proteins, not to detect other viruses or pathogens.
4. The person under the age of 18 must be tested with the assistance of the legal guardian or a licensed person.
5. Keep the test kit or kit components out of reach of children and pets before and after use.
6. The packaging of the test paper contains a essicant, 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 the skin, mucous membranes or eyes, rinse with water. Please contact your GP or professional and seek medical advice if necessary.
8. It is recommended to use gloves or other protective equipment when testing.
9. It is forbidden 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 aluminum bag 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 may cause bleeding of the nasal cavity, breakage and tampon retention, or other risks.
15. Do not immerse the swab in the extraction solution or other liquid before collecting the sample with disposable swabs.
16. Do not touch the soft tip of the tampon when handling the swab sample.
17. Proper sample collection and manipulation are key to correct results.
18. Do not mix batch components of different kits.
19. All components of the kit are disposable items. Do not use with multiple samples. Do not reuse the test kit or the kit components used.
20. Before deciding to implement relevant treatment or management decisions, it is recommended to communicate with family doctors or professionals. Do not take medicine in private or any action that may endanger yourself or others.
21. Used test kit components and samples can be placed in plastic bags along 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 working surface to ensure hygiene.
22. Do not eat, drink, smoke in the area where you handle samples or test kits.

storage
The test kit must be stored in a condition of 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 aluminum bag.
Validity packaging intact: 24 months.

Format
Material Provided:
- 1 test;
-Test device;
-Extraction tube;
-Disposable buffer;
-Bag for biohazard waste;
-Instructions for use.