BARDA expands partnership with Ortho Clinical Diagnostics to develop high-throughput, automated COVID-19 antigen test

BARDA expanded an existing partnership with Ortho Clinical Diagnostics to accelerate the development of a SARS-CoV-2 Antigen test and to support advancements for the two SARS-CoV-2 antibody tests currently available.

The VITROS^® SARS-CoV-2 Ag (Antigen) Test is designed for the rapid detection of the virus that causes COVID-19 and is intended for the qualitative detection of nucleocapsid SARS-CoV-2 antigens (SARS-CoV-2 protein) in nasopharyngeal (NP) swabs collected from individuals suspected of COVID-19 infection.

The VITROS^® Anti-SARS-COV-2 Total antibody test is intended for the detection of all COVID-19 related antibodies (IgG, IgM, and IgA); Ortho’s COVID-19 IgG antibody test detects the IgG antibody which appears in a patient’s blood in the later phase of the infection and remains elevated even after recovery. The benefit of different types of tests is that they offer choices in tracking, surveillance, and overall patent management. Both Ortho antibody tests can help health care workers assess whether a patient has been infected, even without showing symptoms, and has developed antibodies to the SARS-CoV-2 virus.

The antigen and antibody tests intended for use on Ortho’s high-throughput, random access, fully-automated VITROS^® Systems including the VITROS^® XT 7600 Integrated System, the VITROS^® 3600 Immunodiagnostic System, the VITROS^® 5600 Integrated System, and the VITROS^® ECi/ECiQ Immunodiagnostic Systems. Ortho has already installed these analyzers in more than 1,000 hospitals and labs across the U.S. VITROS Systems are self-contained and do not require an external water source to run, offering labs placement flexibility.

Ortho Clinical Diagnostics manufactures several million tests each week at their sites in Rochester, New York, and Pencoed, United Kingdom.

This award is one component of BARDA's rapidly expanding COVID-19 medical countermeasure portfolio.

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