Humasis COVID-19 Ag Test uses monoclonal antibodies specific to COVID-19 specific antigens in human nasopharyngael swab specimens. A nitrocellulose membrane strip in the device contains one test line and one control line. The test line is pre-coated with anti-mouse monoclonal antibody to SARS-CoV-2 Nucleocapsid and RBD for the detection of SARS-CoV-2 antigens, and the control line is coated with goat anti-mouse IgG. When the extracted swab specimen is added to the sample well, it will migrate to the conjugate pad, which contains conjugated antibodies conjugated with colloidal gold directed against the SARS-CoV-2 antigen. If the sample contains SARS-CoV-2 antigens, antigen-antibody-conjugate complex will be formed. The complex will continue to migrate across the membrane until it reaches the capture zone (test line) where the complex will bind to immobilised antibodies and form a visible coloured band in the test line. The sample will continue to move along the membrane until it reaches the control line where excess conjugate binds and produces a second visible line. This control line indicates that the sampe has migrated across the membrane as intended and the test was performed properly. Results available in 15 minutes.
The kit contains test devices, disposable test tube, filter caps and sterilised swabs for specimen collection for 25 tests.
Limit of Detection: 2 x 103 TCID50/mL
Clinical sensitivity: 92.00% (23/25) (95% CI: 75%-97.8%)
Clinical specificity: 100.00% (20/20) (95% CI: 83.9%-100.0%)
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