FDA has granted an emergency use authorization for the SARS-CoV-2 total antibody test from Bio-Rad Laboratories, Hercules, Calif. The test has also met the CE mark requirements for sale in Europe.
The company’s blood-based immunoassay can help clinicians determine whether an individual has developed antibodies against SARS-CoV-2. Clinical evaluation of the test has demonstrated diagnostic specificity of more than 99% and sensitivity of 98%. Crossreactivity testing demonstrated specificity of 100%, with no reactivity against other interfering substances, including non-SARS-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,” says Dara Wright, executive vice president of Bio-Rad Laboratories and president of the company’s clinical diagnostics group. “The total antibody approach enables detection of antibodies in the majority of patients 8 days after the onset of symptoms, versus an IgG-only approach.”
Bio-Rad’s SARS-CoV-2 total antibody test can be performed manually or on an automated immunoassay platform such as Bio-Rad’s Evolis system, which offers high-throughput processing and sample traceability.
For more information, visit Bio-Rad Laboratories.