Reagent Kit Vitros® SARS-CoV-2 Antigen For use with Vitros 3600 Immunodiagnostic System and Vitros 5600 / XT 7600 Integrated Systems 100 Tests
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
Product Specifications
Description
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