Immunoassay Reagent Advia Centaur® SARS-CoV-2 Antigen For Advia Centaur XP / Centaur XPT Immunoassay Systems 100 Tests

Features

• ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag) assay is only for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
• The ADVIA Centaur® SARS-CoV-2 Antigen (CoV2Ag) assay is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in anterior nasal (AN) swab specimens collected in Siemens Healthineers Sample Inactivation Media, from individuals who are suspected of COVID-19 by their healthcare provider within the first 7 days of symptom onset, using the ADVIA Centaur® XP and ADVIA Centaur® XPT systems
• Testing is limited to 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 ADVIA Centaur SARS-CoV-2 Antigen assay does not differentiate between SARS-CoV and SARS-CoV-2
• 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 results to the appropriate public health authorities
• Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed; 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 ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag) assay is intended for use by trained clinical laboratory personnel specifically instructed and trained in in vitro diagnostic procedures and proper infection control procedures
• Kit contains: 1 ReadyPack primary reagent pack containing ADVIA Centaur CoV2Ag Lite Reagent and Solid Phase, 1 ReadyPack ancillary reagent pack containing ADVIA Centaur CoV2Ag Ancillary Reagent, and ADVIA Centaur CoV2Ag master curve card
• The following materials are required to perform these assays, but are not provided: 11208047 ADVIA Centaur CoV2Ag CAL (calibrator), 11207868 ADVIA Centaur CoV2Ag QC (quality control material), 11208651 Sample Inactivation Media (inactivation reagent), 03395373 ADVIA Centaur Ancillary Probe Wash 1 (probe wash), 03333963 ADVIA Centaur Probe Wash 3 (probe wash), 01137199 (112351) ADVIA Centaur Wash 1 (wash), 03773025 ADVIA Centaur Wash 1 (wash)

More Information

• ADVIA Centaur SARS-CoV-2 Antigen FDA EUA Letter
• ADVIA Centaur SARS-CoV-2 Antigen IFU
• ADVIA Centaur SARS-CoV-2 Antigen Healthcare Providers Fact Sheet
• ADVIA Centaur SARS-CoV-2 Antigen Patients Fact Sheet
• SDS