Product Overview
The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody test is a chemiluminescent immunoassay designed for the qualitative detection of total antibodies to SARS-CoV-2 in human serum and plasma. It serves as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
This test is intended for use by authorized laboratories under the U.S. Food and Drug Administration's (FDA) Emergency Use Authorization (EUA).
Key Components & Identification
- Product Name: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Reagent Pack and Calibrators
- Model/Code: CV2TN, REF 619 9975, REF 619 9976, REF 619 9924
- Manufacturer: Ortho Clinical Diagnostics
Intended Use & Limitations
- Qualitative detection of total antibodies to SARS-CoV-2.
- Aid in identifying individuals with adaptive immune response (recent or prior infection).
- Important: Not for diagnosing acute SARS-CoV-2 infection.
- Results should be interpreted in conjunction with clinical findings and other laboratory tests.
- Performance characteristics have not been established for individuals vaccinated against COVID-19.
Operational Information
- For in vitro diagnostic and laboratory professional use only.
- Requires specific VITROS systems for operation.
- Refer to the full Instructions for Use for detailed procedures, warnings, and quality control.
