Overview
A rapid immuno-chromatographic assay for the qualitative detection of COVID-19 antigen (viral nucleoprotein) from a nasopharyngeal swab.
Intended Use
Intended to aid in the rapid differential diagnosis of COVID-19 virus infection in patients with signs and symptoms of respiratory infection; reactive specimens should be confirmed by alternative methods together with clinical findings.
Directions for Use
1. Add 400 µL of extraction buffer (approximately 12 drops) into the reagent tube.
2. Add the nasopharyngeal swab to the tube with extraction buffer.
3. Vigorously rotate and twist the swab against the side of the tube at least 10 times.
4. Squeeze the sides of the tube to obtain as much liquid as possible, then dispose of the swab properly.
5. Apply the cap to the tube, hold it vertically, and add 2 drops (about 80-100 µL) of the specimen without air bubbles into the sample well.
6. Read the result at 20 minutes; do not interpret after 30 minutes.
Reading the Result
1. Positive – a clear pink control band (C) and a detectable test band (T) appear.
2. Negative – a pink colored band appears only at the control region (C).
3. Invalid – no visible band appears at the control region (C); repeat with a new test kit.






