Ortho’s Quantitative COVID-19 IgG Antibody Test First to Receive FDA Emergency Use Authorization

Ortho Clinical Diagnostics’ (Raritan, NJ, USA) VITROS Anti-SARS-CoV-2 IgG Quantitative Test has become the first quantitative COVID-19 IgG antibody test to receive US Food and Drug Administration (FDA) Emergency Use Authorization (EUA).

Ortho’s new quantitative COVID-19 IgG antibody test targets the S1 spike protein and is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. The test offers 100% specificity and excellent sensitivity. The new test is calibrated to the World Health Organization (WHO) International Standard 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. With the FDA EUA, Ortho is now the only company that offers laboratories in the US a quantitative IgG test to the spike protein in addition to a total antibody test to the nucleocapsid protein.


“The development of the VITROS Anti-SARS-CoV-2 IgG Quantitative Test shows Ortho’s leadership in response to the need for standardization of SARS-CoV-2 serological methods currently used,” said Ivan Salgo, MD, head of medical, clinical, and scientific affairs, Ortho Clinical Diagnostics. “Ortho’s quantitative COVID-19 IgG antibody test, which targets the spike protein, is an important tool to help health care and policy teams to understand long-term antibody responses to SARS-CoV-2.”