Siemens 11207584 - Antibody Test Master… | USA MedPremium
Antibody Test Master Curve Material Atellica® IM SARS-CoV-2 Total Level 1, 2, 3, 4 4 X 1 mL
USAMP#66404369SKU: 11207584Atellica® IM
Product Spotlight
Atellica® IM SARS-CoV-2 Total (COV2T) assay is ONLY for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
The Atellica® IM SARS-CoV-2 Total Master Curve Material (COV2T MCM) is for in vitro diagnostic use in the verification of calibration and measuring interval of the Atellica® IM SARS-CoV-2 Total (COV2T) assay
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform moderate or high complexity tests
Atellica IM SARS-CoV-2 Total (COV2T) assay is intended as an aid in identifying patients with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection; at this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity
Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
The sensitivity of the Atellica IM SARS-CoV-2 Total (COV2T) assay early after infection is unknown; negative results do not preclude acute SARS-CoV-2 infection - if acute infection is suspected, direct testing for SARS-CoV-2 is necessary
False positive results for the Atellica IM SARS-CoV-2 Total (COV2T) assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes
