Description
Colloidal gold immunochromatography for the rapid qualitative detection of SARS-CoV-2 nucleocapsid antigens present in human nasal swab specimens in vitro.
The test detects SARS-CoV-2 nucleocapsid antigens with orocolloid immunochromatography using a double antibody sandwich test.
The test cassette contains: colloidal gold-labeled anti-SARS-CoV-2 protein nucleocapsid antibody, a detection line (T) and a quality control line (C) fixed on a nitrocellulose membrane. The T line is fixed with another anti-SARS-CoV-2 nucleocapsid protein antibody. The QC antibody is fixed on the C line.
When the appropriate amount of sample is added to the sample well of the test cassette, the sample will move forward along the test strip by capillary action.
If the sample contains SARS-CoV-2 nucleocapsid antigens and the concentration is above the limit of detection, the antigens will bind to the colloidal gold labeled anti-SARS-CoV-2 nucleocapsid antibody protein. The immune complex will be captured by another anti-SARS-CoV-2 nucleocapsid protein antibody immobilized on the membrane, forming a red line in the T-zone and indicating a positive result.
If the sample does not contain SARS-CoV-2 nucleocapsid antigens or the concentration is below the limit of detection, a negative result is displayed.
The kit is designed to be used as a self-test. It is suitable for use by individuals 18 years of age and older, with clinical symptoms of SARS-CoV-2 infection or suspected of COVID-19.
If the individual exhibits respiratory symptoms or is suspected to be infected, it is recommended to combine PCR testing, clinical symptoms, prevalence, and additional clinical data for diagnosis confirmation.

How to use
Wash and dry your hands carefully.
Read the package insert carefully and check the expiration date on the foil pouch containing the test cassette.
The test kit must be used within 1 hour of opening the foil pouch.

Testing procedure
Tear the seal on the extraction tube and place the tube in the tube holder.
Insert the swab into one nostril (to a depth of 2.5 cm). Be sure to collect any nasal discharge that may be present. Gently roll the swab against the inside of the nostril at least 5 times. Using the same swab, repeat the procedure in the other nostril.
Insert the swab into the extraction tube and rotate it against the inner wall of the tube at least 10 times. Press the swab from the outer wall of the tube at least 5 times. Lift the swab above the liquid in the tube and squeeze the swab from the outer wall of the tube to release as much sample as possible into the tube. Close the test tube with the appropriate measuring cap.
Open the foil pouch and place the test cassette on a clean, flat surface.
Add 4 drops of processed sample to the sample well on the Test Cassette.
Read the result within 15-20 minutes. The result after 20 minutes is invalid.
Place all used components in the biosafety bag and seal tightly.

Interpretation of results
Positive: If both the quality control line (C) and the detection line (T) appear, SARS-CoV-2 antigens have been detected and the result is positive. The color intensity of the detection line (T) is relative to the concentration of SARS-CoV-2 antigens contained in the sample. The