BARDA expanded partnership with Ortho Clinical Diagnostics to develop high-throughput, automated COVID-19 antigen and further advancements to antibody tests

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BARDA expanded an existing partnership with Ortho Clinical Diagnostics to accelerate 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 millions 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; visit BARDA’s COVID-19 Portfolio to learn more.

About Ortho Clinical Diagnostics, Inc.:

The following information is provided by company and does not indicate endorsement by the federal government of the company or its products.

Ortho Clinical Diagnostics is a global leader of in vitro diagnostics dedicated to improving and saving lives through innovative laboratory testing and blood-typing solutions.

Ortho proudly serves the clinical laboratory and transfusion medicine communities with customized solutions that enhance clinical outcomes, improve lab performance, overcome staffing challenges and better manage costs.

Ortho Clinical Diagnostics is powered by Ortho Care™, their global, award-winning, holistic approach to service, which supports customers with best-in-class technical support, award-winning field support, and remote service and inventory support.

For more information about Ortho’s solutions and services, visit

Last Updated: September 18, 2020

COVID-19 Medical Countermeasure Portfolio

This award is one component of BARDA's expanding COVID-19 medical countermeasure portfolio; visit BARDA's COVID-19 Portfolio to learn more.