Coronavirus COVID-19 Antigen Self Test (1 pc/box)
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COVID-19 antigen self test introduction
The WESAIL COVID-19 antigen self test kit remains capable of detecting the mutated omicron coronavirus variant (download manufacturer’s certificate). The coronavirus COVID-19 antigen self test is intended for self testing the SARS-CoV-2 nucleocapsid protein. This test is authorized for self-collected human anterior nasal swab specimens from individuals who are suspected of COVID-19 within the first seven days of symptom onset.
Product name: COVID-19 Antigen Self Test
Specimen type: Nasal (2-3 cm)
Kit size: 1 pc/box
Manufacturer: Guangdong Wesail Biotech Co., Ltd.
Expiration date: 2023.04.02.
File number: OGYÉI/45528-6/2022
Registration number: HU/CA01/45528/22
Main components of the COVID-19 antigen self test
- 1 pc test cassette
- 1 pc specimen collection swab
- 1 pc lysis buffer
- 1 pc nozzle cap with protective cover
- 1 pc product insert
- 1 pc medical waste bag
Principle of the procedure
When the sample is added to the sample well, the nucleocapsid protein in the sample reacts with the gold-labeled antibody. It forms an immuno-complex, which flows onto the nitrocellulose membrane. When the immuno-complex reaches the T Line (Test band), it reacts with the COVID-19 antibody pre-coated on the nitrocellulose membrane then develops color on the T Line (Test band), which indicates a positive result.
Regardless of whether the sample contains nucleocapsid protein, the gold labeled quality control antigen will bind to the coated antibody at the C band and develop color.
Sample Collection for anterior nasal swab
1. Take a specimen collection swab from the pouch.
2. Carefully insert the swab into one nostril of the patient about 2-3 cm.
3. Slowly scrape the nasal wall for 5 times. Repeat this process at the other nostril by using the some swab to ensure thot an adequate sample is collected from both nasal cavities.
4. Then slowly take out the specimen collection swab from the nostril. It is recommended to hold your breath when taking an anterior nasal swab.
Caution: Please read the product insert of the kit carefully. Before starting the test, wash your hands use hand sanitizer.
1. Pierce the seolin membrane of lysis buffer tube with the tip of nozzle cap.
2. Unplug the nozzle cap from the tube and place it on the workbench with the protective cover facing down. Be careful not to touch he nozzle tip to avoid contamination. Insert the swab into the lysis buffer tube. Squeeze the tub and stir the swab for 5 times.
3. Keep squeezing the tube and remove the swab. Make sure all the liquid from the swab is removed.
4. Install the nozzle cap with the protective cover facing up. Mix the tube by gently shaking for 10 times. Let stand for 1 minute.
5. Remove the protective cover. Add three drops of processed specimen vertically into the sample well, and then let stand for 15 minutes.
6. Read the test result immediately, the test result will be invalid after 30 minutes.
Interpretation of results
Colored bands appear at both test band (T) and control band (C).
Colored band appears at control band (C) only.
No visible colored bond appears at the control band. The test procedures may not be followed correctly, or the cassette has deteriorated. It is recommended to retest the specimen.