Cat#BDT-19
EC Certificate NO.1434-IVDD-521/2021

Clinical performance
The sensitivity was 90% .
The specificity was 99.752%. 
The accuracy was 96.523%. 
INTENDED USE
 
Rapid SARS-CoV-2 Antigen Test Card is for rapid and qualitative detection SARS-CoV-2 virus antigen (including all known variants) in anterior nasal (front nose) swabs of individuals.

TEST PROCEDURE
1. Carefully insert the swab into the user's nostril. The swab tip should be inserted up to 2.5cm(1 inch) from the edge of the nostril. 
2. Dab along the lining of the nostril and roll the swab several times.
3. Remove the swab from the nasal cavity. 
4. Add the sample extraction buffer into extraction tube, then place the swab with specimen into the extraction tube. Roll the swab three to five (3-5) times. Leave the swab in the sample extraction buffer for 1 minute.
​​​​5. Pinch the extraction tube with fingers and remove the solution from the swab as much as possible.
6. Install the nozzle cap onto the sample extraction tube tightly. Use extraction solution as test specimen. 
7. Open the pouch and remove the card. After opening, the test card must be used immediately. 
8. Invert the extraction tube, and gently squeeze the extraction tube, add 2-3 drops of the test sample into the sample hole (S). 
9. Read the result at 15-20 minutes.
Note: The result after 20 minutes may not be accurate.

INTERPRETATION OF TEST RESULTS
Positive:​​​​​​
One ribbon appears in the control zone (C) and the other ribbon appears in the test zone (T). ​​​​​
Negative:
Only one ribbon appears in the control zone (C) and there is no ribbon in the test zone (T).
Invalid result:
No ribbon shows in the Control Zone (C).