Ortho Clinical: Covid-19 Antibody Test Gets Emergency Authorization From FDA

By Stephen Nakrosis

Ortho Clinical Diagnostics Holdings PLC on Friday said its Vitros Anti-SARS-CoV-2 IgG Quantitative Test became the first quantitative Covid-19 IgG antibody test to receive an emergency use authorization from the U.S. Food and Drug Administration.

Ortho said the 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 company also said the test is calibrated to the World Health Organization International Standard for anti-SARS-CoV-2 IgG antibodies.

Ivan Salgo, the company's head of medical, clinical, and scientific affairs, said, "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."

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

July 09, 2021 16:30 ET (20:30 GMT)

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