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

(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."