Siemens 11208048 - Calibrator Set Atellica… | USA MedPremium
Calibrator Set Atellica® IM SARS-CoV-2 Antigen 4 X 1 mL For Calibrating the Atellica IM CoV2Ag Assay using an Atellica Immunoassay Analyzers
USAMP#68691031SKU: 11208048Atellica® IM
Product Spotlight
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
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 contains: 2 x 1.0 mL low calibrator, 2 x 1.0 mL high calibrator and calibrator lot-specific value sheet
