Immunoassay Reagent Vitros® SARS-CoV-2 Antigen For Vitros 3600 Immunodiagnostic System and Vitros 5600 / XT 7600 Integrated Systems 100 Tests

Features

• The Vitros SARS-CoV-2 Antigen Reagent Pack used in combination with the Vitros SARS-CoV-2 Antigen Calibrator is for use under an FDA EUA only: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
• Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet the requirements to perform moderate or high complexity tests
• The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen test is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasopharyngeal (NP) specimens from individuals who are suspected of COVID-19 by their healthcare provider within one to six days of the onset of symptoms using the VITROS 3600 Immunodiagnostic System and the VITROS 5600/XT 7600 Integrated Systems
• Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status; positive results do not rule out bacterial infection or co-infection with other viruses
• Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
• Negative results from patients with symptom onset outside of one to six days should be treated as presumptive
• Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions
• Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19
• The VITROS SARS-CoV-2 Antigen test is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures, and proper infection control procedures
• EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act
• 48 Minutes time to first result
• Reagent pack contains 100 coated wells, 6 mL assay reagent and 16.2 mL conjugate reagent

More Information

• Vitros SARS-CoV-2 Antigen Reagent Pack and Calibrator FDA EUA Letter
• Vitros SARS-CoV-2 Antigen Reagent Pack IFU
• Vitros SARS-CoV-2 Antigen Healthcare Providers Fact Sheet
• Vitros SARS-CoV-2 Antigen Patients Fact Sheet