Ortho Clinical Diagnostics expands COVID-19 test offerings

Ortho Clinical Diagnostics, one of the world’s largest pure-play in vitro diagnostics companies, has announced its qualitative COVID-19 Total N antibody test received U.S. Food and Drug Administration EUA. This new antibody test is the fifth assay to receive EUA within Ortho’s COVID-19 testing solutions. The test detects the individual’s immune response or total antibodies to the COVID-19 virus and is intended to help clinicians understand if their patient had a recent or prior COVID-19 infection.

Ortho’s new qualitative VITROS^® Anti-SARS-CoV-2 Total N antibody test is designed to capture the nucleocapsid protein, detect total antibodies to the COVID-19 virus, and is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. The test offers 99.2% specificity and excellent sensitivity.1 Ortho is the first company to have an EUA for both a quantitative IgG antibody assay targeting the spike protein and a total assay targeting the nucleocapsid protein.

About Ortho’s VITROS^® COVID-19 Testing Solutions

Ortho’s VITROS^® COVID-19 Testing Solutions help labs meet the demands of the pandemic with reliable, high-throughput testing solutions that offer SARS-CoV-2 infection and antibody testing on Ortho's trusted VITROS^® Systems.

Up to 150 antibody tests or up to 130 antigen tests can be processed each hour on Ortho’s VITROS Systems, already installed in more than 1,000 labs across all 50 states in the U.S and in over 5,400 labs across the world.

The VITROS^® SARS-CoV-2 Antigen Test is a high-throughput, highly accurate test that detects acute infection of SARS-CoV-2. The VITROS^® COVID-19 antibody tests include IgG and Total tests that target the S1 spike protein.

The VITROS^® COVID-19 Performance Dashboard allows labs to easily view COVID-19 antibody testing data and enables more informed decisions. The web-based system provides productivity information regarding Ortho analyzers, test volumes, workload balance, sample quality metrics, and reagent efficiency.

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