The VITROS® SARS-CoV-2 Antigen test is a random-access, high-throughput test for the accurate detection of SARS-CoV-2 infection. Designed for performance, the VITROS® SARS-CoV-2 Antigen test targets the Nucleocapsid Protein, the most abundant protein of the SARS-CoV-2 virus, optimizing test sensitivity. Instrument throughput targeted for up to 130 tests per hour on-board instrument. Now available on the VITROS® XT 7600 and 5600 Integrated Systems, and the VITROS® 3600 Immunodiagnostic System.
Time to first result: 48 minutes
Sample Volume: Pre-Extracted 400 μL
Sample Volume: Post-Extraction 80 μL not including dead volume
Calibration Interval: Lot change or every 28 days
Reagent on-board stability: Up to 4 weeks
Reagent Type: Liquid Ready to Use
Specimens Recommended: Nasopharyngeal (NP)*
Quality Controls: Positive and Negative
*Ortho continues to validate other specimen types. See Instructions for Use for transport media validated by Ortho.
The VITROS® SARS-CoV-2 Antigen test has met the requirements for a diagnostic test cited in Section IV, Policy C in the following FDA Guidance: Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff -- Document issued on the web on May 11, 2020. The VITROS® SARS-CoV-2 Antigen has been validated but FDA’s independent review of the labeling and validation is pending. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.