Intended use:
The GeneFinderTM COVID-19 Ag Plus Rapid Test is a lateral flow immunochromatographic assay intended for the qualitative detection of antigen from SARS-CoV-2 in nasopharyngeal or nasal swab specimens directly collected, or nasopharyngeal swab collected in transport media, from individuals suspected of COVID-19 by their healthcare provider within seven days of symptom onset.
- All necessary reagents provided (individually packed)
- Highest accuracy - Sensitivity (96.7%) and Specificity (99%)
Principle of the test:
GeneFinder COVID-19 Ag Rapid Test uses monoclonal antibodies specific to COVID-19 antigens to detect COVID-19 specific antigens in human nasopharyngeal swab specimens. A nitrocellulose membrane strip in the device has a test line and a control line. The test line is pre-coated with anti-mouse monoclonal antibody to SARS-CoV-2 nucleocapsid and RBD for 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 migrates to the conjugate pad, which contains antibodies against the SARS-CoV-2 antigen conjugated with colloidal gold. If the sample contains SARS-CoV-2 antigens, an antigen-antibody conjugate complex is formed. The complex continues to migrate across the membrane until it reaches the detection area (test line) where the complex binds to immobilized antibodies and forms a visible colored band in the test line. The sample continues to move along the membrane until it reaches the control line, where excess conjugate binds and forms a second visible line. This control line indicates that the sample migrated along the membrane as intended and that the test was performed properly.
Reagents and materials included:
- Test devices individually packed in aluminum bags (25 tests / box)
- Disposable test tubes with extraction buffer (25 pcs / box )
- Filter cap (25 pcs / box )
- Sterilized swabs for sampling (25 pcs / box )
- Instructions for use
Results interpretation:
Performance characteristics:
- Sensitivity 96.03%
- Specificity 99.78%
Video instructions: 