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HHS/BARDA supports DiaSorin, Inc to develop a fully automated serology test to detect novel coronavirus infections

BARDA Response

BARDA is collaborating again with DiaSorin, this time to develop a clinical laboratory test to identify people 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 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.

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 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.

The system is a fully automated, easy to use, quantitative detection platform that performs a range of immunodiagnostic assays. The platform consists of the automated LIAISON instrument and an immunodiagnostics assay workflow.

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.

This award is one component of BARDA’s Rapidly-Expanding COVID-19 Medical countermeasure portfolio, visit BARDA’s COVID-19 Portfolio to learn more.

 

About the Company:

The following information has been provided by the company and does not indicate an endorsement by the U.S. government of the company or its products.

DiaSorin, Inc., 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: https://www.diasorin.com.

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