SARS-COV-2 Antigen Rapid Tests（For Self-testing）

Intended Use

SARS-COV-2 Antigen Rapid Tests is a rapid visual immunoassay for the direct and qualitative detection of viral SARS-CoV-2 nucleoprotein antigens in nasal swabs. This test is intended for personal use by people aged 18 and over who are suspected to be infected with COVID-19. Children 2-15 years of age should be tested by an adult. Children aged 15 and over should be assisted by an adult. Do not use this test on children under 2 years of age. SARS-CoV-2 Antigen Rapid Tests is for self-testing use. The test procedure is not automated. Test results should not be used as a sole basis for diagnosis but should always be interpreted by a physician in the clinical context.

Package Contents

Test Devices

Extraction buffers

Instruction for use

Individually wrapped swabs

Plastic garbage bags

Desiccants

Tube Stand

Specification

Application

Precautions

● Do not use the test on children under 2 years of age.

● Children aged between 2 and 18 years old must be supervised or aided by an adult when carrying out the test.

● The SARS-CoV-2 Antigen Rapid Tests is for self-testing use.

Prepare for the Test

● The test should be used at room temperature (15℃ to 30 ℃).

If the test has been stored in a cool place (below 15 ℃), allow the test to stand at room temperature for 30 minutes before use.

● Make sure that all packaging is intact. Do not use the test if the foil packaging is visibly damaged.

● Do not open the foil package until you are ready to perform the test. Use the test within 1 hour of opening.

Test Procedure

1. Before starting the test, clean the table surface.

2. Wash your hands thoroughly with soap and warm water or hand sanitizer for 20 seconds. If you do more than one test, clean the surface and wash your hands again between each test.

3. Just prior to performing the test, open the foil pouch, remove the test device, and place it on a clean, flat surface. For best results, the test should be performed within an hour.

4. Gently squeeze both ends of the stand until it stands up.

5. Insert the extraction buffer into the well on the tube stand and unscrew the blue cap.

6. Gently blow your nose into a tissue to remove any excess mucus and toss the tissue into a closed container. Wash your hands with soap and water or use hand sanitizer for 20 seconds. Open the swab packaging. To do this, pull the loose ends of the packaging apart. Remove the swab from the stem. Do not touch the padded tip of the swab.

a) Insert the swab about 1-2cm into the nostril.(Collect the anterior nasal swab specimen)

b) Gently twist the swab 5 times against the nasal wall. The swab should remain in the nostril for 15 seconds.

c) Pull the swab out of the nose while twisting it slightly.

d) Repeat the process with the same swab in the other nostril, also for 15 seconds.

7. Place the swab into the tube.

8. Rotate the swab while squeezing the lower part of the tube 10-15 times so that a slight pressure is exerted on the tip of the swab.

9. Remove the swab. Squeeze the tube to squeeze as much liquid out of the swab as possible.

10. Screw the blue cap back onto the extraction tube and unscrew the top white cap

11. Invert the tube and add 3 drops of the solution to the sample well by gently squeezing the tube.

12. Look at the clock. You can read the result after 15 minutes. After more than 20 minutes, the result is no longer valid.

13. When your test is finished, put all of the contents of the test kit you used in the waste bag provided. Dispose of the closed waste bag with household waste.

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