This rapid kit is used for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen (hereinafter referred to as SARS -CoV-2 N-antigen) in anterior nasal swab samples.

This rapid kit is based on the Colloidal Gold Method to detect SARS-CoV-2 N-antigen. The SARS-CoV-2 N-antigen in the sample forms a complex with the antibody labeled with colloidal gold. This complex migrates along the membrane and reaches the test region (T-line) on which a second antibody against the SARS-CoV-2 N-antigen is applied. Unbound colloidal gold migrate along the membrane to the control region (C-line) and are bound by the control region antibody.

If both the T-line and the C-line are red, the test result is SARS-CoV-2 N- antigen positive; if only the C-line is red and no T-line becomes visible， the test result is SARS-CoV-2 N-antigen negative. If no C-line becomes visible, the test result is invalid and the sample must be retested with a new test cassette.

1 TESTS KIT COMPONENTS

5 TESTS KIT COMPONENTS

25 TESTS KIT COMPONENTS

COLLECTION OF NASAL SWAB SAMPLES

(1) Remove the Swab from the pouch and hold with the handle only. Do not touch the swab tip.

(2) Gently insert the swab up to 1/2 to 3/4 of an inch into the nostril of the patient. Roll the swab around the inside wall of nostril at least 4 times.

(3) Repeat swab step for the other nostril with the same swab to ensure adequate sample is collected.

TEST PROCDURE FOR SWAB SAMPLES

Step 1: Transfer 8 drops of extraction buffer to the extraction vial.

Step 2: Insert the swab into the extraction vial. Rotate the swab 5 times and squeeze the sides of the extraction vial to mix the sample in the buffer.

Step 3: Remove the swab while squeezing the sides of the extraction vial to extract the liquid from the swab as much as possible. Discard the swab.

Step 4: Place the filter cap on the extraction tube and press firmly so that the cap sits tightly in the extraction vial.

Step 5: Place the test cassette on a flat surface. Apply 3 drops of extracted sample to the sample well of the test cassette.Dispense the sample at 90 degree angle to avoid bubbles.

Step 6: After 15 minutes of development time, observe the result window for the result.

Instructions

Instructions(Self testing)

Registered by the BfArM (Germany) BASG(Austria)