For ADVIA Centaur XP / XPT / CP Immunoassay Systems
Form
Ready-to-Use Liquid
Number of Tests
100 Tests
Product Dating
SLI Medical Acceptable Dating: we will ship >= 90 days
Sample Type
Human Serum / Plasma Sample
Specialty
Requires Refrigeration
Storage Requirements
Chemiluminescent Immunoassay
Test Category
SARS-CoV-2 IgG (sCOVG)
Test Format
Antibody Test
Test Method
41116010
Test Name
40 µL Sample Volume
Test Type
UNSPSC Code
Volume
Features
The ADVIA Centaur SARS-CoV-2 IgG (sCOVG) 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-serology-and-other-adaptive-immune-response-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 requirements to perform moderate or high complexity tests
The ADVIA Centaur® SARS-CoV-2 IgG (sCOVG) assay is a chemiluminescent immunoassay intended for qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma (lithium heparin) using the using the ADVIA Centaur® XP
ADVIA Centaur® XPT
and ADVIA Centaur® CP Immunoassay Systems
Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
The sensitivity of the ADVIA Centaur SARS-CoV-2 IgG (sCOVG) assay early after infection is unknown; negative results do not preclude acute SARS-CoV-2 infection
False positive results for the ADVIA Centaur SARS-CoV-2 IgG (sCOVG) assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes
Samples should only be tested from individuals who are 15 days or more post symptom onset
Kit Contents: 1 ReadyPack primary reagent pack containing ADVIA Centaur sCOVG Lite Reagent
Solid Phase
and Ancillary Well Reagent; 1 ReadyPack ancillary reagent pack containing ADVIA Centaur sCOVG DIL; ADVIA Centaur sCOVG master curve card 1 vial ADVIA Centaur sCOVG CAL low calibrator; 1 vial ADVIA Centaur sCOVG CAL high calibrator; ADVIA Centaur sCOVG CAL calibrator assigned value sheets and barcode labels
