Ortho Clinical Diagnostics, Raritan, N.J., launched the first quantitative COVID-19 IgG antibody test in addition to a total COVID-19 nucleocapsid antibody test.

Ortho is the only company that offers laboratories in the United States a quantitative test in combination with a nucleocapsid test. Both tests help healthcare teams differentiate the cause of antibodies against SARS-CoV-2 and are processed on Ortho’s Vitros systems.

“In the United States, all vaccines administered are designed to create an antibody response against the spike protein of the SARS-CoV-2 virus,” says Ivan Salgo, MD, head of medical, clinical, and scientific affairs, Ortho Clinical Diagnostics. “Ortho’s new quantitative IgG antibody test, together with its new nucleocapsid antibody test, can provide additional data to help determine whether an antibody response came from natural infection or a spike-protein targeting vaccine.”

Ortho’s Vitros Anti-SARS-CoV-2 IgG Quantitative Antibody test is the first antibody test available in the United States that provides numerical values calibrated to the World Health Organization (WHO) International Standard. Standardized quantitative antibody tests help align SARS-CoV-2 serological methods and allow for unified data comparison across laboratories. This uniform data is a first step toward understanding the rise and fall of antibodies in individuals and long-term impacts of the COVID-19 pandemic on communities and the overall population.

Ortho’s new IgG quantitative test is intended for the qualitative and quantitative measurement of IgG antibodies to SARS-CoV-2 in human serum and plasma with 100% specificity and excellent sensitivity.

Ortho’s new Vitros Anti-SARS-CoV-2 Total Nucleocapsid Antibody Test is a highly accurate test for the qualitative detection of SARS-CoV-2 nucleocapsid antibodies in patients who have been infected with the SARS-CoV-2 virus.

“We continue to learn new things about the SARS-CoV-2 virus each day and Ortho is dedicated to equipping labs with highly accurate solutions that help them tackle both the present-day and future challenges of this ongoing pandemic,” says Chockalingam Palaniappan, PhD, chief innovation officer, Ortho Clinical Diagnostics.

Ortho’s COVID-19 quantitative antibody test completed the process for emergency use notification (EUN) from the FDA 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 process for EUN on May 5, 2021 and an EUA was also submitted.