Known as a serology assay, the test detects the presence of IgG antibodies specific to the virus in a person’s blood. Having certain levels of these immuno-protective antibodies indicates that the person is convalescent (recovering or recovered from COVID-19). This knowledge is particularly important for healthcare providers and workers in essential industries such as utilities and food production and may inform a person’s decision on when to return to work after potential exposure to the virus.
BARDA and DiaSorin entered into a public-private partnership, with BARDA contributing approximately $180,000 and DiaSorin funding the total remaining project cost.
DiaSorin’s assay runs on the company’s FDA 510(k) cleared LIAISON XL instrument platform used routinely in hundreds of hospital and reference diagnostic laboratories across the U.S. The platform fully automates management of the diagnostic process, allowing laboratories to process up to 170 patient blood samples per hour, with a minimum level of intervention required by laboratory operators and results in less than 45 minutes. This availability and speed increases the current capacity for testing to detect past infections in people who are recovering or recovered from COVID-19.
This serological test is the second DiaSorin COVID-19 test to be supported by BARDA; the first was the SimplexaTM COVID-19 Direct assay, a molecular test for qualitative identification of SARS-CoV-2 which was developed by subsidiary, DiaSorin Molecular, LLC, of Cypress, California.