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Accelerate Diagnostics, BioCheck Receive FDA Emergency Use Authorization for SARS-CoV-2 Antibody Tests

NEW YORK – Accelerate Diagnostics and BioCheck announced Thursday that the BioCheck SARS-CoV-2 IgM and IgG individual test kits received Emergency Use Authorization from the US Food and Drug Administration.

Last month, BioCheck's MS-Fast instrument and BioCheck SARS-CoV-2 IgM and IgG Combo Test received EUA. The instrument and tests will be marketed and commercialized by Accelerate Diagnostics after an April commercial supply and collaboration agreement between the two companies.

The BioCheck chemiluminescence tests process human serum samples in 30 minutes to detect IgG and IgM antibodies signifying a previous COVID-19 infection. The tests target the S1 protein, which Accelerate said has the fewest similarities to other coronaviruses and can cut down on false positives due to cross reactivity. 

"Offering the individual BioCheck SARS-CoV-2 IgM and IgG tests alongside the BioCheck SARS-CoV-2 IgM and IgG Combo Test will provide our customers with the flexibility to meet their specific testing needs," Accelerate CEO Jack Phillips said in a statement.