First Total COVID-19 Antibody Test Receives Emergency Use Authorization From the FDA

The FDA has granted Bio-Rad Laboratories Emergency Use Authorization for the company’s SARS-CoV-2 Total Ab test.

The FDA has granted Bio-Rad Laboratories Emergency Use Authorization (EUA) for the company’s severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Total Ab test. This test is the first total antibody test that has received an EUA from the FDA.1

The blood-based immunoassay test will be able to help clinicians identify whether an individual has antibodies against SARS-CoV-2, the virus associated with coronavirus disease 2019 (COVID-19). The test will be available for use both manually or on an automated immunoassay platform.1

In the clinical evaluation of the SARS-CoV-2 Total Ab test, it presented diagnostic specificity of more than 99% and diagnostic sensitivity of 98%. Furthermore, when researchers conducted cross-reactivity testing, they found the test presented specificity of 100%, with the results also presenting no reactivity against other interfering specimens, including non-CoV-2 coronaviruses.1

“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,” said Dara Wright, MBA, Bio-Rad Clinical Diagnostics group EVP and president, in a press release. “We are pleased to have received FDA Emergency Use Authorization for our SARS-CoV-2 Total Antibody test to support COVID-19 diagnosis.”1

REFERENCE

  • Bio-Rad’s SARS-CoV-2 (COVID-19) Serology Test Granted FDA Emergency Use Authorization, the First Total Antibody Test to Receive EUA from the FDA [news release]. Hercules, CA: Bio-Rad Laboratories, Inc. April 30, 2020. businesswire.com/news/home/20200430006016/en. Accessed May 1, 2020.