Bio-Rad Laboratories, Inc., a global leader of 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.

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 immunoglobulin. 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.