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).

Benefits

• Easy to use
• 2-step procedure
• FDA EUA-approved, CLIA - waived
• Rapid results within 15 minutes

Contents

• 20x Test Devices
• 20x Disposable Pipettes
• 20x Alcohol Prep Pads
• 20x Sterile Safety Lancets
• 1x Sample Diluent
• 1x Instructions For Use (IFU)

Specification

• 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