Bio-Rad’s SARS-CoV-2 Serology Test Becomes First Total COVID Antibody Test to Secure FDA EUA

Bio-Rad Laboratories, Inc. (Hercules, CA, USA) has been granted US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the company's SARS-CoV-2 Total Ab test, making it the first total antibody test to secure 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. 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.

Clinical evaluation of the SARS-CoV-2 Total Ab test has demonstrated diagnostic specificity of more than 99% and diagnostic sensitivity of 98%. Cross-reactivity testing demonstrated specificity of 100% 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."