COVID-19 Serology Test Available COVISURE™ COVID-19 IgM/IgG Rapid Test
The Hemosure COVISURE™ COVID-19 IgM/IgG Rapid Test is a lateral flow immunoassay test device for the rapid presumptive qualitative simultaneous detection and differentiation of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum or plasma. It is being offered as outlined in Section IV.D of the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019 (May 2020).
The FDA does not intend to object to the development and distribution by commercial manufacturers, or development and use by laboratories, of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to FDA, and information along the lines of the following is included in the test reports and instructions for use:
- This test has not been reviewed by the FDA.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
- Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
- Test Type: Rapid Antibody (IgM/IgG)
- Specimen Type: Human whole blood, serum or plasma
- Turnaround Time: Not valid before 15 minutes or after 20 minutes
- FDA Status: EUA pending
- CLIA Complexity: Highly complex
COVID-19 Ig M/IgG Rapid Test