Siemens 11207868 - Antigen Test Control… | USA MedPremium
Antigen Test Control Set ADVIA Centaur® SARS-CoV-2 Antigen Level 1: Negative, Level 2: Positive 4 X 1.6 mL
USAMP#20611814SKU: 11207868Advia Centaur®
Product Spotlight
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
Kit contents: 2 X 1.6 mL negative quality control, level 1, 2 X 1.6 mL positive quality control, level 2 and quality control assigned value sheet
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
Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
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
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
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
