The assay is currently undergoing clinical evaluation in several hospitals, but 700 samples of data have shown specificity above 99%.
After being infected with SARS-CoV-2, viral antigens stimulate the immune system to produce antibodies and fight the virus. Bio-Rad suggests the blood-based immunoassay kit can help clinicians determine if an individual has been infected by the virus and developed an immune response.
“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,” clinical diagnostics executive VP and president Dara Wright said in a news release. “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.”
Bio-Rad’s immunoassay kit can detect total immunoglobulin and is designed for manual use or on an automated immunoassay platform like the company’s Evolis System.
The company plans to offer the immunoassay kit globally and plans to use the FDA’s emergency use authorization process to expedite U.S. availability.