Ortho Clinical Diagnostics Receives FDA Emergency Use Authorization

12 July 2021 | Monday | News

Ortho Clinical Diagnostics' Quantitative COVID-19 IgG Antibody Test First to Receive FDA Emergency Use Authorization
Image Source : Public Domain

Image Source : Public Domain

Ortho's new VITROS® Anti-SARS-CoV-2 IgG Quantitative Test targets the S1 spike protein and is calibrated to the 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

- Ortho is the only company that offers laboratories in the U.S. a quantitative IgG test to the spike protein in addition to a total antibody test to the nucleocapsid protein

 Ortho Clinical Diagnostics (Nasdaq: OCDX), one of the world's largest pure-play in vitro diagnostics companies, today announced its VITROS® Anti-SARS-CoV-2 IgG Quantitative Test is the first quantitative COVID-19 IgG antibody test to receive U.S. 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.1

The new test is calibrated to the World Health Organization (WHO) International Standard2 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.

"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." 


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