NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization to Ortho-Clinical Diagnostics for a SARS-CoV-2 total antibody test.
The Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total N Reagent Pack used in combination with the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators is designed to detect total antibodies against the virus in serum and plasma.
The chemiluminescent immunoassay is authorized for use in identifying individuals with an adaptive immune response to SARS-CoV-2 and runs on Ortho-Clinical's Vitros ECi, ECiQ, 3600, 5600, and XT 7600 systems.
The test may be used by any lab CLIA certified to perform moderate- or high-complexity tests, the FDA said.
Earlier this month, Raritan, New Jersey-based Ortho-Clinical received EUA from the FDA for its Ortho-Clinical Diagnostics' Vitros Anti-SARS-CoV-2 IgG Quantitative test.