Calibrator Set AdviseDx SARS-CoV-2 IgG II 6 X 2 mL For the Calibration of the Alinity i Systems when used for the Qualitative and Semi-Quantitative Detection of IgG Antibodies to SARS-CoV-2 in Human Serum

Features

• The AdviseDx SARS-CoV-2 IgG II assay is for use under an Emergency Use Authorization Only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas#individual-serological
• Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C 263a, that meet 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
• The AdviseDx SARS-CoV-2 IgG II assay is a chemiluminescent microparticle immunoassay (CMIA) intended for the qualitative and semi-quantitative detection of IgG antibodies to SARS CoV-2 in human serum (including collected using a serum separator tube) and plasma (acid citrate dextrose, sodium citrate, dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin in a separator tube, and sodium heparin) on the Alinity i system
• At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity
• The AdviseDx SARS-CoV-2 IgG II assay should not be used to diagnose or exclude acute SARS-CoV-2 infection
• A positive result may not indicate previous SARS-CoV-2 infection; consider other information, including clinical history and local disease prevalence, in assessing the need for a second but different serology test to confirm an immune response
• A negative result for an individual subject indicates the absence of detectable anti-SARS CoV-2 antibodies; Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions
• A negative result can occur if the quantity of the anti-SARS-CoV-2 antibodies in the specimen is below the detection limits of the assay, or if the antibodies are not present during the stage of disease in which a sample is collected
• The AdviseDx SARS-CoV-2 IgG II Calibrator Kit is for the calibration of the Alinity i system when used for the qualitative and semi quantitative detection of IgG antibodies to SARS-CoV-2 in human serum (including collected using a serum separator tube) and plasma (acid citrate dextrose, sodium citrate, dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin in a separator tube, and sodium heparin)
• Calibrator A contains phosphate buffer and protein (bovine) stabilizer
• Calibrators B - F contain anti-SARS-CoV-2 IgG (human, monoclonal) in phosphate buffer with protein (bovine) stabilizer

More Information

• AdviseDx SARS-CoV-2 IgG II FDA EUA Letter
• AdviseDx SARS-CoV-2 IgG II for Alinity i System Calibrator
• AdviseDx SARS-CoV-2 IgG II Recipients Fact Sheet
• AdviseDx SARS-CoV-2 IgG II Healthcare Providers Fact Sheet