Covid-19 nasal swab rapid self-diagnostic antigen test

Product Description

Rapid test intended for the qualitative detection of SARS-CoV-2 antigen (nucleocapsid protein) found in nasal cavity (anterior nasal) specimens from individuals with suspected COVID-19 infection. The test kit is intended for self-testing or at-home testing.

Indications

This test uses immune lateral chromatography technology.
When the test specimen contains SARS-CoV-2, the SARS-CoV-2 antigen will react with the coated antibody on the test line (T) to cause a red band to appear in the test line (T) area; when the SARS-CoV-2 content in the test specimen is too low or nonexistent, 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.

Directions for Use and Dosage

1. Use the test kit at room temperature (15°C-30°C). If the kit has previously been stored in a cool place (below 15°C), equilibrate to 15°C-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.
   Then dry your hands.
4. Check the components in the box for damage or breakage.

Sample Collection:

1. Remove the sample extraction tube; unscrew the tube cap.
2. Place the extraction tube on the bracket (attached to the box) to prevent liquid spillage.
3. Tear the swab packaging from the end of the stick 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. Withdraw the extraction tube, dip the soft swab head into the extraction solution, and immerse it in the liquid.
2. Press the soft swab head firmly against the inside 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. If possible, remove the swab.
4. Tighten the tube cap for standby.

Sample Test:

1. Tear the foil pouch, remove the test card and place it horizontally on the test bench.
2. Disconnect the sample addition hole cover 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 testing, place all kit materials in the biohazard waste bag and dispose of it according to your 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 in the red band, while the test line (T line) does not appear in the 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. For use with nasal cavity (anterior nasal) swab specimens.
3. For protein detection only from SARS-CoV-2, not to detect other viruses or pathogens.
4. A person 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 packaging contains a desiccant; eating is prohibited.
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 GP or a healthcare 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. Do not use a test kit that has not been stored as directed.
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 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 packaging is damaged or opened.
14. Use of the swab must strictly follow the instructions for use; otherwise, it may cause serious injury. This may cause nasal 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. Proper 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 samples. Do not reuse the used test kit or kit components.
20. Before making any relevant therapeutic or management decisions, it is recommended to communicate with family doctors or professionals. Do not take medicines in private or do anything that could put you in danger.
21. Used test components and samples can be placed in plastic bags with normal household waste. If the test result is positive, carefully dispose of any 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 specimens or test kits are handled.

Storage

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

Format

The kit contains:

Test device.
Extraction tube.
Disposable swab.
Biohazard bag.
Instructions for use.