Ortho Clinical Diagnostics, one of the world’s largest pure in vitro diagnostic companies, announced the launch of the first quantitative COVID-19 IgG antibody test and a comprehensive COVID-19 nucleocapsid antibody test.
Ortho is the only company in the United States that provides a combination of quantitative testing and nucleocapsid testing for laboratories. Both of these tests help the medical team distinguish the cause of antibodies against SARS-CoV-2 and process them on Ortho’s trusted VITROS® system.
“In the United States, all vaccines vaccinated are designed to produce an antibody response to the spike protein of the SARS-CoV-2 virus,” said Ivan Sargo, MD, Ortho Clinical Diagnostics, head of medicine, clinical and scientific affairs. “Ortho’s new quantitative IgG antibody test, together with its new nucleocapsid antibody test, can provide additional data to help determine whether the antibody response comes from a natural infection or a spike protein-targeted vaccine.”1
Ortho’s VITROS® Anti-SARS-CoV-2 IgG quantitative antibody test is the first antibody test in the United States to provide values calibrated according to the World Health Organization (WHO) international standards. 2 The standardized quantitative antibody test helps to align the SARS-CoV- 2 serological methods and allows uniform data comparison across laboratories. This unified data is the first step in understanding the rise and fall of individual antibodies and the long-term impact of the COVID-19 pandemic on the community and the overall population.
Ortho’s new IgG quantitative test is designed to qualitatively and quantitatively measure IgG antibodies against SARS-CoV-2 in human serum and plasma, with 100% specificity and excellent sensitivity. 3
Ortho’s new VITROS® Anti-SARS-CoV-2 Total Nucleocapsid Antibody Test is a highly accurate 4 test for the qualitative detection of SARS-CoV-2 nucleocapsid in patients who have been infected with the SARS-CoV-2 virus Antibody.
“We are constantly learning new knowledge about the SARS-CoV-2 virus every day, and Ortho is committed to equip laboratories with highly accurate solutions to help them cope with the current and future challenges of this continuing epidemic,” said Dr. Chockalingam Palaniappan , Chief Innovation Officer of Ortho Clinical Diagnostics.
Ortho’s COVID-19 quantitative antibody test completed the U.S. Food and Drug Administration (FDA) emergency use notification (EUN) process on May 19, 2021, and submitted an emergency use authorization (EUA) for the test to the FDA. Its VITROS® Anti-SARS-CoV-2 total nucleocapsid antibody test completed the EUN process on May 5, 2021, and also submitted the EUA.
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1. Patients vaccinated with inactivated virus vaccines will develop anti-N and anti-S antibodies. 2. https://www.who.int/publications/m/item/WHO-BS-2020.2403 3. 100% specificity, 92.4% sensitivity more than 15 days after the onset of symptoms 4. 99.2% specificity and 98.5% PPA ≥ 15 days after the onset of symptoms
Post time: Jun-22-2021