Coronacheck Assure Rapid Test
Manufacturer
Product Type
Product Brochure
The Assure Rapid antibody test uses a fingerstick blood specimen to provide a rapid result for individuals who want to understand their prior exposure to the COVID-19 virus. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Assure Rapid Antibody Test for Point of Care Use
The Assure COVID-19 IgG/IgM Rapid Test Device is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
Important Information
At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Assure COVID-19 IgG/IgM Rapid Test Device should not be used to diagnose acute SARS-CoV-2 infection.
The test is for professional use only.
This test is also authorized for use with fingerstick whole blood specimens only at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
