Description
A rapid test for the qualitative detection of SARS-CoV-2 antigen (nucleocapsid protein) found in nasal cavity (anterior nasal) samples from individuals with suspected COVID-19 infection. The test kit is intended for self-testing or home testing.
This test 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) to make a red band appear in the test line area (T); when the SARS-CoV-2 content in the test sample is too low or non-existent, no red band appears in the test line area (T). Regardless of whether the test sample contains SARS-CoV-2, a red band will appear in the quality control line area (C), which is the basis for judging whether the test is effective.

Instructions for use
1. Use the test kit at room temperature (15°C-30°C). If the kit has been previously stored in a cool place (temperature below 15°C), balance to 15°C-30°C for 30 minutes before testing.
2. Prepare a timer, tissues, hand sanitizer/soap and warm water.
3. Wash hands thoroughly (at least 20 seconds) with soap and warm water/hand sanitizer. Then dry hands.
4. Check the components in the box and ensure there is no damage or breakage.
Sample collection:
1. Take out the sample extraction tube; unscrew the tube cap.
2. Place the extraction tube on the stand (fixed to the box) to avoid liquid spills.
3. Tear open the swab packaging from the stick end and remove the swab.
4. Insert the soft head of the swab 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. Take out the extraction tube, immerse the soft head of the swab in the extraction solution and submerge it in the liquid.
2. Firmly press the soft head of the swab against the inner wall of the extraction tube and rotate the swab clockwise or counter-clockwise approximately 10 times.
3. Push the swab head along the inner wall of the sample extraction tube under the liquid in the tube as far as possible, remove the swab.
4. Tighten the tube cap for standby.
Sample testing:
1. Tear open the aluminum foil pouch, take out the test card and place it horizontally on the test bench.
2. Unscrew the sample addition hole cap of the extraction tube.
3. Gently squeeze the extraction tube and drop 2 drops of liquid into the sample well of the test card.
4. Start timing, read the test results at 15 minutes. Do not read before 15 minutes or after 30 minutes.
5. After the test, place all kit materials in the biohazard waste bag and dispose of according to local biohazard waste disposal policy.
6. Rinse hands thoroughly for at least 20 seconds with soap and warm water/hand sanitizer.
Negative: The quality control line (C line) appears as a red band, while the test line (T line) does not appear as a red band.
Positive: Both the quality control line (C line) and the test line (T line) appear as red bands.

Warnings
1. For in vitro diagnostic use only.
2. To be used with nasal cavity (anterior nasal) swab samples.
3. For the detection of SARS-CoV-2 proteins only, not for detecting other viruses or pathogens.
4. Persons under 18 years of age should be tested with the assistance of a legal guardian or authorized 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 desiccant, which is not edible.
7. The sample extraction solution in the extraction tube contains chemical components. Direct contact should be avoided and eating is prohibited. If the solution comes into contact with skin, mucous membranes or eyes, rinse with plenty of water. Please contact your family doctor or a professional or seek medical advice if necessary.
8. The use of gloves and other protective equipment is recommended when performing tests.
9. Test kits must be stored according to the storage conditions required in the instructions for use. It is forbidden to use test kits that have 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 the aluminum foil pouch until just before use. Do not use if the pouch is damaged or open.
13. Disposable swabs are sterile products. Do not use if the swab packaging is damaged or open.
14. The use of the swab must strictly follow the instructions for use; otherwise it may cause nasal cavity bleeding, swab breakage and retention, and 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 swab when handling the swab sample.
17. Correct sample collection and handling are critical 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 samples. 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 medication privately or take any action that may endanger you.
21. Used test components and samples can be placed in plastic bags along with normal household waste. If the test result is positive, carefully dispose of waste components and relevant samples and thoroughly clean and disinfect the work surface to ensure hygiene. If there are special waste requirements in local laws and regulations, they must be strictly observed.
22. Do not eat, drink or smoke in the area where samples or test kits are handled.

Storage
Store between 2°C and 30°C, in a dry place and away from direct sunlight (do not freeze the kit or its components).
Shelf life unopened: 12 months.
Shelf life once opened: 60 minutes.

Format
Main components of the kit:
- Test device.
- Extraction tube.
- Disposable swab.
- Biohazard waste bag.
- Instructions for use.