Ortho Clinical Diagnostics’ COVID-19 antibody test ready for use after receiving authorization from USFDA

US – Ortho Clinical Diagnostics, one of the world’s largest pure-play in vitro diagnostics companies, received an emergency use authorization (EUA) from the US Food & Drug Administration (FDA) for its VITROS Anti-SARS-CoV-2 IgG Quantitative Test.

The new quantitative COVID-19 IgG antibody test is the first quantitative COVID-19 IgG antibody test to receive USFDAs EUA and is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2.

Ortho’s VITROS COVID-19 Testing Solutions will 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.

Its COVID-19 antibody tests include IgG and Total tests that target the S1 spike protein, and a Total test that targets the nucleocapsid protein.

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, HIT levels and reagent efficiency.

Currently, the new test is calibrated to the World Health Organization (WHO) International Standard2 for anti-SARS-CoV-2 IgG antibodies, which gives clinicians and public health leaders a standard tool to measure antibody response to SARS-CoV-2.

This uniform data is a first step toward understanding the rise and fall of antibodies in individuals and the long-term impacts of the COVID-19 pandemic on communities and the overall population.

About In Vitro Diagnostics

In vitro diagnostic (IVD) devices are tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick.

IVDs can detect diseases or other conditions and can be used to monitor a person’s overall health to help cure, treat, or prevent diseases.

There are several types of SARS-CoV-2 and COVID-19 related IVDs and they include:

  • Diagnostic Tests: Tests that detect parts of the SARS-CoV-2 virus and can be used to diagnose infection with the SARS-CoV-2 virus. These include molecular tests and antigen tests.
  • Serology/Antibody and Other Adaptive Immune Response Tests: Tests that detect antibodies (for example, IgM, IgG) to the SARS-CoV-2 virus or that measure a different adaptive immune response (such as, T cell immune response) to the SARS-CoV-2 virus. These types of tests cannot be used to diagnose a current infection.
  • Tests for Management of COVID-19 Patients: Beyond tests that diagnose or detect SARS-CoV-2 virus or antibodies, there are also tests that are authorized for use in the management of patients with COVID-19, such as to detect biomarkers related to inflammation.

Once patients are diagnosed with COVID-19 disease, these additional tests can be used to inform patient management decisions.

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