Immunoassay Reagent / Calibrator Kit Advia Centaur® SARS-CoV-2 IgG (sCOVG) For Advia Centaur CP / Centaur XP / Centaur XPT Immunoassay Systems 100 Tests
USAMP#53794470SKU: 11207376Advia Centaur®
Product Spotlight
- 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
