Ortho Clinical's COVID-19 Total N Antibody Test Receives FDA's Emergency Use Authorization

(RTTNews) - Ortho Clinical Diagnostics (OCDX) said that its qualitative COVID-19 Total N antibody test received an emergency use authorization from the U.S. Food and Drug Administration.

The new antibody test is the fifth assay to receive EUA within Ortho's COVID-19 testing solutions. The test detects the individual's immune response or total antibodies to the COVID-19 virus and is intended to help clinicians understand if their patient had a recent or prior COVID-19 infection.

Ortho's new qualitative VITROS Anti-SARS-CoV-2 Total N antibody test is designed to capture the nucleocapsid protein, detect total antibodies to the COVID-19 virus, and is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. The test offers 99.2% specificity and excellent sensitivity.