COVID-19 Ag Test: A nitrocellulose membrane strip on the left side of 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.
Influenza A/B Ag Test: A nitrocellulose membrane strip on the right side of the device contains two test lines and one control line. The test line A is pre-coated with monoclonal antibody to Influenza A, test line B is pre-coated with monoclonal antibody to Influenza B 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, influenza A/B antigen. If the sample contains the targeted antigens, antigen-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
COVID-19 virus is 5 x 100.8 TCID50/mL, for Influenza A H1N1 antigen is 2.075ng/mL, for Influenza A H3N2 antigen is 5.5ng/mL and for Influenza B virus is 78ng/mL.
Clinical sensitivity
COVID-19; 95.5% (107/112) (95% CI: 90.0%-98.1%)
Influenza A; 100% (28/28) (95% CI: 87.9%-100%)
Influenza B; 100% (25/25) (95% CI: 86.7%-100%)
Clinical specificity
COVID-19; 100.00% (191/191) (95% CI: 98.0%-100.0%)
Influenza A; 98.6% (71/72) (95% CI: 92.5%-99.8%)
Influenza B; 100% (75/75) (95% CI: 95.1%-100%)
For more information, pricing and availability contact sales@clsdiagnostics.com