SARS-CoV-2 Antigen Test Kit (LFIA) is a colloidal gold immunochromatography for the rapid qualitative detection of SARS-CoV-2 nucleocapsid antigens present in human anterior nasal samples in vitro. The test kit is designed for use as self-testing. This test kit is intended for individuals by 18 or older with clinical symptoms of SARS-CoV-2 infection or who are suspected of COVID-19. If the suspected individual exhibits respiratory symptoms or suspected to be infected, it is recommended to combine PCR test, clinical symptoms, prevalence and further clinical data to confirm the diagnosis. SARS-CoV-2 Antigen Test Kit (LFIA) detects the SARS-CoV-2 nucleocapsid antigens with colloidal gold immunochromatography using a double antibody sandwich assay.
The test cassette contains:
(1) colloidal gold-labeled anti-SARS-CoV-2 Nucleocapsid Protein antibody,
(2) one detection T line and one quality control C line fixed on a nitrocellulose membrane.
T line is fixed with another anti-SARS-CoV-2 Nucleocapsid Protein antibody for detecting SARS-CoV-2. The quality control antibody is fixed on the C line. When the appropriate amount of test sample treated with lysis bu¬ffer is added to the sample well of the test cassette, the sample will move forward along the test strip via capillary action. If the sample contains SARS-CoV-2 nucleocapsid antigens and concentration is higher than the limit of detection, the antigens will bind to the colloidal gold-labeled anti-SARS-CoV-2 Nucleocapsid Protein antibody. The immune complex will be captured by another anti-SARS-CoV-2 Nucleocapsid Protein antibody immobilized on the membrane, forming a red T line and indicating a positive result for SARS-CoV-2. If the sample contains no SARS-CoV-2 nucleocapsid antigens or concentration is lower than the limit of detection, a negative result is displayed.
Product Directions:- Tear the seal of the lysis buffer and place it on the test-tube rack.
- Insert the swab (stick with larger absorbent tip) into a nostril (2.5 cm). Be sure to collect any nasal drainage that may be present. Carefully rotate the swab in a circular path 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 lysis buffer and rotate the swab against the inner tube wall 10 times.
- Squeeze the swab from the outer tube wall 5 times. Lift the swab above the buffer solution, squeeze the swab from the outer tube wall one time to leave the sample in the tube as much as possible.
- Break the swab and cover the tube with the dropper.
- Add 4 drops processed sample extract into the sample well.
- Read the results within 15-20 mins.
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