Bio-Rad Laboratories has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 Total Ab serology test.
The firm’s SARS-CoV-2 Total Ab is claimed to be the first total antibody test that secured EUA status from the FDA.
The blood-based immunoassay test enables clinicians to detect the virus linked with COVID-19 disease based on the developed antibodies against SARS-CoV-2 in an individual.
Bio-Rad has also achieved CE mark requirements for the blood-based immunoassay test in Europe.
According to the company, the clinical assessment of the SARS-CoV-2 Total Ab test has shown diagnostic specificity of over 99% and diagnostic sensitivity of 98%.
Cross-reactivity testing showed the specificity of 100% with no reactivity against other interfering specimens including non-CoV-2 coronaviruses, said the company.
The serology test can be used manually or on an automated immunoassay platform
The SARS-CoV-2 Total Ab test provides the flexibility to use manually or an automated immunoassay platform such as the company’s EVOLIS system.
The company has designed the EVOLIS system to deliver high throughput processing and sample traceability.
Bio-Rad Clinical Diagnostics Group EVP and president Dara Wright said: “We are pleased to have received FDA Emergency Use Authorization for our SARS-CoV-2 Total Antibody test to support COVID-19 diagnosis.
“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.”
In April 2019, Bio-Rad Laboratories received FDA approval for its BioPlex 2200 Lyme Total assay.
The BioPlex 2200 Lyme Total assay is an advanced multiplex test method, which will be used in the diagnosis of Lyme disease.
Bio-Rad is engaged in the development, manufacturing and marketing of a range of advanced products for the life science research and clinical diagnostic markets.
