The Health Canada Approved COVID-19 Antibody Rapid Test is a lateral flow in-vitro immunoassay intended to detect the presence of SARS-CoV-2 IgM and IgG antibodies instantly from a whole blood sample collected from a minimally invasive fingerstick blood collection process.
The test is intended for both laboratory and point-of-care settings (POC).
- Easy to use
- 2-step procedure
- FDA EUA-approved, CLIA - waived
- Rapid results within 15 minutes
- 20x Test Devices
- 20x Disposable Pipettes
- 20x Alcohol Prep Pads
- 20x Sterile Safety Lancets
- 1x Sample Diluent
- 1x Instructions For Use (IFU)
- IgG sensitivity: 90.0%, specificity: 100.0%. IgM sensitivity: 100.0%, specificity: 98.8%.
- Overall positive agreement rate of 80.8%, negative agreement rate of 100.0%.
- Sample Type: Fingertip blood, whole blood sample, serum and plasma
- Detection Method: Colloidal Gold
- Detection Time: 10 – 15 minutes
- Suitable for Point of Care Testing, CLIA waived
- FDA EUA approved; CE Certified, Health Canada approved
Rapid COVID-19 Testing