Self-Test Rapid SARS-CoV-2 Antigen Test Card

A home test for the rapid qualitative detection of SARS-CoV-2 virus antigen in anterior nasal swabs within 7 days of symptom onset.

Performance Characteristics

Sample type: nasal swab 

Time to result: 15-20 min

Sensitivity: 96.77% 

Specificity: 99.20% 

Accuracy: 98.72%

Layperson study statistics: 

99.10% of non-professionals carried out the test without requiring assistance 

97.87% of different types of results were interpreted correctly

Test Procedures

1. Rotate the lid of sample extraction buffer bottle. Caution: Open it away from your face and be  careful not to spill any of the liquid.

2. Squeeze all extraction buffer out of the bottle into  the extraction tube. Caution: Avoid touching the bottle against the  tube.

3. Identify the soft, fabric tip of the swab. Peel open the swab packaging and gently take out the swab. Caution: Never touch the soft, fabric tip of the  swab with your hands.

4. Carefully insert swab into one nostril. The swab tip  should be inserted no less than 2.5 cm (1 inch) from  the edge of the nostril. Roll swab 3-4 times along  the mucosa inside the nostril. Leave swab in the  nostril for several seconds. Using the same swab,  repeat this process for the other nostril. Withdraw  swab from the nasal cavity. Caution: This may feel uncomfortable. Do not  insert the swab any deeper if you feel strong  resistance or pain.

5. Place swab into extraction tube. Roll swab three to  five (3-5) times. Leave swab in extraction buffer  for 1 minute.

6. Pinch extraction tube with fingers and remove the  solution from swab as much as possible.

7. Install the nozzle cap onto the sample extraction  tube tightly.

8. Bring the kit components to room temperature  before testing. Open the pouch and remove the  card. Place the card on a flat and level surface. Caution: Once opened, the test card must be  used immediately

9. Invert the extraction tube and add 3 drops of test  specimen into the specimen well (S) by gently  squeezing the extraction tube. Caution: The formation of air bubbles in the  specimen well (S) must be avoided.

10. Read the results at 15-20 minutes. Caution: Results after 20 minutes may not be  accurate.

Interpretation of Results

Positive: If two colored bands appear with one colored band in the Control Zone  (C) and another in the Test Zone (T) within 15-20 minutes, the test result is positive. 

Caution: No matter how faint the colored band is in the Test Zone (T), the result should be considered as positive.

Negative: If one colored band appears in the Control Zone (C) and no colored  band appears in the Test Zone (T) within 15-20 minutes, the test result  is negative.

Invalid: If no color line appears in the control area (C) within 15-20 minutes,  the test is invalid. Repeat the test with a new test card