FDA gives emergency use authorization to SARS-CoV-2 Total Ab Test for COVID-19 diagnostics.- Bio-Rad Labs

Bio-Rad Laboratories announced that it was granted 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.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.