COVID-19 News

BARDA partners with DiaSorin to develop serological COVID-19 test

Biomedical Advanced Research and Development Authority (BARDA) is collaborating again with Italian diagnostics company DiaSorin, this time to develop a clinical laboratory test to identify individuals who have been infected with the SARS-COV-2 virus but have recovered.

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 immunoprotective antibodies indicates that a 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.

This diagnostic test has been designed to respond to the need to identify people in the population who had already been infected with the virus, but whose diagnosis has not been confirmed by performing a swab and a molecular diagnostic test, or who have recovered from recent infection.

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 minimal intervention required by laboratory operators and results in less than 45 minutes. This availability and speed should increase the current capacity for detecting past infections and tracking recovery in those with known infections.

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.

BARDA and DiaSorin entered into a public-private partnership, with BARDA contributing approximately $180,000 and DiaSorin funding the total remaining project cost.

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