SARS-CoV-2 Antigen Test Kit(GICA)

The SARS-CoV-2 Antigen Test Kit is a gold immuno-chromatographic assay (GICA) that is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab, and saliva specimens directly from individuals who are suspected of COVID-19 by their healthcare provider.

Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results should be treated as presumptive and confirmed

with a molecular assay, if necessary for patient management. Negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. The SARS-CoV-2 Antigen Test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings.

Production information

1. Open your test kit and take out all the components.

2. Twist off the top of the buffer bottle, slowly dispense all of the buffer into the extraction tub.

3. Open and take out the swab

4. Carefully insert the swab into the nostril until you fell a slight resistance (about 1.5-2.5cm up your nose). Using gentle rotation, roll the swab firmly around the inside of the nostril, making 5 complete circles each nostril, and then slowly remove it while wiping.

5. Elution of samples from swabs

6.Open pouch and place the card on a clean, dry, flat surface

7. Apply 3 drops of extracted sample at a 90º angle to the specimen well of the test card.

8. Wait 15 minutes

9. Interpret the test results at 15~20 minutes.