Bio-Rad’s SARS-CoV-2 serology test becomes first total antibody test to secure FDA EUA

Bio-Rad Laboratories, Inc., a global leader of life science research and clinical diagnostic products, has announced that it was granted U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the company's SARS-CoV-2 Total Ab test, the first total antibody test receiving EUA from the FDA. 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.

“We are pleased to have received FDA Emergency Use Authorization for our SARS-CoV-2 Total Antibody test to support COVID-19 diagnosis,” said Dara Wright, Bio-Rad Clinical Diagnostics Group EVP & President. “The total antibody approach enables detection of antibodies in the majority of patients eight days after the onset of symptoms, versus an IgG-only approach," she said.

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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