Total antibody test from Bio-Rad Laboratories granted EUA from FDA

May 4, 2020

Bio-Rad Laboratories has been granted Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the company's SARS-CoV-2 Total Ab test. Bio-Rad's blood-based immunoassay test can help clinicians identify if an individual has developed antibodies against SARS-CoV-2, the virus associated with COVID-19 disease. The test has also met the CE mark requirements for Europe.

Clinical evaluation of the SARS-CoV-2 Total Ab test has demonstrated diagnostic specificity of more than 99 percent and diagnostic sensitivity of 98 percent. Cross-reactivity testing demonstrated specificity of 100 percent with no reactivity against other interfering specimens including non-CoV-2 coronaviruses.

The SARS-CoV-2 Total Ab test can be used manually or on an automated immunoassay platform, such as Bio-Rad's EVOLIS System, which offers high throughput processing and sample traceability.

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