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BARDA supports a second COVID-19 antibody test by DiaSorin, Inc.

BARDA Response

BARDA is expanding a partnership with DiaSorin, Inc. to bring an additional COVID-19 test to market. In April 2020, BARDA supported the validation and submission of DiaSorin’s COVID-19 IgG serology test to the Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) to use the test in U.S. laboratories. That test detects the presence of antibodies to SARS-CoV-2 in the blood of a recently infected individual and can provide up to 170 test results per hour. Now that the company has obtained an EUA for their IgG assay, BARDA will support the validation and EUA submission for an IgM antibody test. Testing for both types of antibodies can be helpful given that SARS-CoV-2 infections can elicit IgM and IgG antibodies in infected individuals with variable timelines.

DiaSorin’s IgG and IgM antibody tests run on their LIAISON® XL instrument platform. The test would be performed in hospital and reference diagnostic laboratories across the U.S. that currently have LIAISON ® XL instruments installed. This will increase the capability for testing to detect current or past infections by adding the detection of IgM antibodies to the existing capability of IgG antibody testing.

Serology tests for SARS-CoV-2 antibodies allow people to know if they have been infected in the recent past, even if they never had symptoms. Research is still ongoing to determine whether these antibodies confer long-lasting protection against re-infection. As more information is learned about this, having a wide breadth of serology tests available in U.S. laboratories will enable a wider testing capability for the population.

DiaSorin’s LIAISON® XL platform is FDA 510(k) cleared and is used routinely in clinical testing labs across the United States. The system is a fully automated, easy to use, detection platform that performs a range of immunodiagnostic assays. The platform consists of the automated LIAISON instrument and an immunodiagnostics assay workflow.

About the Company:

DiaSorin is a global leader in the laboratory diagnostics market, specializing in the immunodiagnostics and molecular diagnostics segments. For over 50 years DiaSorin Group has been developing, producing, and commercializing diagnostic tests. DiaSorin supports clinical laboratory needs and activities, providing solutions that are reliable, innovative, fully automated and standardized. DiaSorin continually invests in Research & Development, using distinctive expertise in the field to deliver a high level of innovation. More information is available at:

Last Updated: August 06, 2020