FDA OKs Bio-Rad’s Assay to Spot COVID-19 Antibodies

Bio-Rad Laboratories Inc., a firm specializing in life science research and clinical diagnostic products, today announced that the company is launching a blood-based immunoassay kit to identify antibodies to the coronavirus SARS-CoV-2, the virus associated with COVID-19. Preliminary performance of the assay has been established and the kit is now undergoing clinical evaluation in several hospitals to further confirm clinical performance. Initial data collected on more than 700 samples has demonstrated specificity above 99 percent.
 
After infection with SARS-CoV-2, viral antigens stimulate the body’s immune system to produce antibodies to fight the virus. Bio-Rad believes its blood-based immunoassay kit will help clinicians determine if an individual has been infected by the virus and therefore has developed an immune response against SARS-CoV-2.
 
“Using a serology test to support the diagnosis of COVID-19 and to screen populations can provide a more complete understanding of infection rates as well as immunity,” said Dara Wright, Bio-Rad Clinical Diagnostics Group EVP & President. “The detection of antibodies to SARS-CoV-2 on a large scale may be used to guide public authorities in their decisions to lift partial or total containment orders according to the serological status of the population. Molecular and serology testing are highly complementary in this regard,” she said.
 
Bio-Rad’s immunoassay kit detects total immunoglobulin (IgG, IgM, and IgA), an approach which appears to be more sensitive than assays against a single immunoglobulin¹. The test was designed for use manually or on an automated immunoassay platform, such as Bio-Rad’s EVOLIS System, which offers high throughput processing and sample traceability.
 
Bio-Rad plans to offer the immunoassay kit globally. In the United States, the company intends to use the FDA’s Emergency Use Authorization process to expedite U.S. availability.
 
Reference
¹ https://doi.org/10.1101/2020.03.02.20030189