Ortho Launches First Quantitative COVID-19 IgG Spike Antibody Test and New Nucleocapsid Antibody Test

Ortho is the only company that offers laboratories in the US a quantitative test in combination with a nucleocapsid test. Both tests help health care teams differentiate the cause of antibodies against SARS-CoV-2 and are processed on Ortho's trusted VITROS Systems. Ortho's VITROS Anti-SARS-CoV-2 IgG Quantitative Antibody test is the first antibody test available in the U.S. 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.

"In the United States, all vaccines administered are designed to create an antibody response against the spike protein of the SARS-CoV-2 virus," said Ivan Salgo, M.D., 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."

"We continue 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," said Chockalingam Palaniappan, PhD, chief innovation officer, Ortho Clinical Diagnostics.