Antigen Test Control Set Atellica® IM SARS-CoV-2 Antigen Level 1: Negative, Level 2: Positive

Features

• The Atellica® IM 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 Atellica® IM SARS-CoV-2 Antigen Quality Control (CoV2Ag QC) is for in vitro diagnostic use in monitoring the performance of the Atellica IM CoV2Ag assay using an Atellica® immunoassay analyzer for the qualitative detection of SARS-CoV-2 nucleocapsid antigen
• 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 Atellica IM SARS-CoV-2 Antigen (CoV2Ag) 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
• Kit contents: 2 X 1.6 mL negative quality control, 2 X 1.6 mL positive quality control and QC assigned value sheet
• For in vitro diagnostic use
• For Prescription use
• For Professional use

More Information

• Atellica IM SARS-CoV-2 Antigen Test FDA EUA Letter
• Atellica IM SARS-CoV-2 Antigen Quality Control
• Atellica IM SARS-CoV-2 Antigen Healthcare Providers Fact Sheet
• Atellica IM SARS-CoV-2 Antigen Patients Fact Sheet
• SDS