Press Release

Statement From Ortho Clinical Diagnostics Regarding the Omicron Variant


Ortho Clinical Diagnostics has been actively monitoring all 26 SARS-CoV-2 variants, including Omicron, on the potential impact to the performance of the VITROS® COVID-19 Testing Solutions including:


  • VITROS® Anti-SARS-CoV-2 Total Assay*
  • VITROS® Anti-SARS-CoV-2 IgG Assay*
  • VITROS® Anti-SARS-CoV-2 IgG Quantitative Antibody Test*
  • VITROS® SARS-CoV-2 Antigen Test
  • VITROS® Anti-SARS-CoV-2 Total N Antibody Test*


To date, based on our assessment, we are confident that the Omicron variant is unlikely to affect the ability of our tests to detect SARS-CoV-2 antigens or antibodies to the virus.


We closely monitor literature reports regarding emerging mutations, and as materials from the Omicron variant become available, we will test the performance of our assays against these variant proteins. Additional analyses include assessments and documentation done twice monthly to understand how the VITROS® Immunodiagnostic Systems perform over time regionally and globally, paying special attention to areas endemic with known variants.


Ortho Clinical Diagnostics has led the U.S. COVID-19 laboratory testing response, with the first emergency use authorization for mass-scale antigenantibodyquantitative antibody, and nucleocapsid and spike antibody tests to serve clinical laboratories' needs as variants have developed.


Now more than ever, COVID-19 testing solutions are vital to the fight against the pandemic and remain a priority, Because Every Test Is A Life™.

*The VITROS® Anti-SARS-CoV-2 Total, VITROS® Anti-SARS-CoV-2 IgG and VITROS® Anti-SARS-CoV-2 IgG Quantitative Antibody Tests use the S1 domain of SARS-CoV-2 in the assay architecture. The VITROS Anti-SARS-CoV-2 Total N Antibody Test (available only in the U.S.) uses the nucleocapsid protein of SARS-CoV-2 in the assay architecture.


About Ortho Clinical Diagnostics

Ortho Clinical Diagnostics (Nasdaq: OCDX) is one of the world’s largest pure-play in vitro diagnostics (IVD) companies.


More than 800,000 patients across the world are impacted by Ortho’s tests each day. Because Every Test is a Life™, Ortho provides hospitals, hospital networks, clinical laboratories and blood banks around the world with innovative technology and tools to ensure test results are fast, accurate, and reliable. Ortho's customized solutions enhance clinical outcomes, improve efficiency, overcome lab staffing challenges and reduce costs.


From launching the first product to determine Rh+ or Rh- blood type, developing the world’s first tests for the detection of antibodies against HIV and hepatitis C, introducing patented dry-slide technology and marketing the first U.S. Food and Drug Administration-authorized high-volume antibody and antigen tests for COVID-19, Ortho has been a pioneering leader in the IVD space for over 80 years.


The company is powered by Ortho Care™, an award-winning, holistic service and support program that ensures best-in-class technical, field and remote service and inventory support to laboratories in more than 130 countries and territories around the globe.

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