FDA Emergency Use Authorization for COVID-19 Antibody Testing System
FDA Emergency Use Authorization for COVID-19 Antibody Testing System

On August 17, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the BioCheck SARS-CoV-2 IgM and IgG Combo Test and the Sophonix MS-Fast Automated Chemiluminescent Immunoassay Analyzing System for COVID-19 antibody testing. Accelerate Diagnostics distributes and supports this serology-based testing platform.

The Sophonix MS-Fast system and BioCheck SARS-CoV-2 Combo Test kits are capable of processing human serum samples in 30 minutes to detect antibodies that indicate recent or prior COVID-19 infection.

Get more information or inquire about ordering

Press Releases

8/24/2020: announcing FDA EUA of the SARS-CoV-2 IgM and IgG Combo Test Kit and the MS-Fast Analyzer
9/10/2020: announcing FDA EUA of the SARS-CoV-2 Individual IgM and IgG Test Kits