Siemens 11207863 - Antigen Test Control… | USA MedPremium
Antigen Test Control Set Atellica® IM SARS-CoV-2 Antigen Level 1: Negative, Level 2: Positive
USAMP#45760102SKU: 11207863Atellica® 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
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
