Ortho Quantitative COVID-19 IgG antibody test receives FDA EUA

July 12, 2021

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.

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