The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to Ortho Clinical Diagnostics for the company’s VITROS Anti-SARS-CoV-2 IgG Quantitative Test.
In an announcement about issuing the EUA, the FDA said that “quantitative serology tests that are traceable to a certified reference material may be helpful for ongoing medical research to study the immune response to SARS-CoV-2.”
Ortho said its 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. Ortho also offers a total antibody test to the nucleocapsid protein.
The new test has 100% specificity and 91.9% sensitivity at greater than 15 days after symptom onset.
Ortho said 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.
