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Ortho Clinical Diagnostics Picks up EUA for COVID-19 Total Antibody Assay: UPDATED

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Ortho Clinical Diagnostics Picks up EUA for COVID-19 Total Antibody Assay: UPDATED
Image by Alexey_Hulsov on Pixabay
The Raritan, NJ-based company’s EUA is the latest in a long line of COVID-19-related authorizations FDA has granted in the past few months.

UPDATE: In April MD+DI shared news that Ortho Clinical Diagnostics received an EUA from FDA for its Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators. In July, Dr. Lily Li, Director, Medical & Scientific Affairs, published a white paper, “Neutralizing Antibodies to SARS-CoV-2: An Important Mechanism of Immunity,” exploring the role neutralizing antibodies could potentially play in preventing viral infection. The paper shares a few details from a recent study of “six different serological tests for their correlation with neutralization assays.” 

The original story follows below.

FDA continues to grant Emergency Use Authorization during the coronavirus crisis. This time the federal agency has granted EUA to Ortho Clinical Diagnostics for a total antibody assay for COVID-19.

The test is called the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators.

The Raritan, NJ-based company said its COVID-19 total antibody test can help determine who can responsibly be permitted to go back to work by aiding in the identification of currently infected or previously exposed individuals who may have developed an immunity.

Ortho Clinical Diagnostics added that the test can also help screen plasma donations for convalescent plasma therapy, which helps critically ill patients fight the virus, help medical professionals and epidemiologists better understand the spread of the disease, and is an important tool for aiding vaccine development efforts to monitor immune responsiveness.

When coupled with information from a molecular test, which detects active infection, it can monitor disease progression by measuring when antibodies appear in the blood.

The firm said the test can be run on the Vitros XT 7600 Integrated System, the Vitros 3600 Immunodiagnostic System, the V5600 Integrated System and will soon be available on VECi/ECiQ Immunodiagnostic Systems. Vitros Systems, already installed in more than 1,000 hospitals and reference labs in the U.S., are self-contained and do not require an external water source to run, offering labs placement flexibility.

"The COVID-19 pandemic continues to impact individuals, families, and communities around the world," said Chris Smith, CEO, Ortho Clinical Diagnostics, in a release. "Ortho is proud to be working toward large-scale solutions that will help people return to work, reducing the strain on both employees and the economy as a whole. Our focus on improving patients' lives through diagnostics led us to rapidly develop this test, providing one of the key resources needed for diagnosing and treating COVID-19. We remain committed to helping laboratories deliver fast, accurate, reliable results to healthcare professionals, patients and the researchers developing the long-term, sustainable management of this disease."

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