Calibrator Set AdviseDx SARS-CoV-2 IgG II 6 X 2 mL For the Calibration of the ARCHITECT 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 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
• 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 Calibrator Kit is for the calibration of the ARCHITECT 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)
• 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
• 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 AdviseDx SARS-CoV-2 IgG II assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes
• Due to the risk of false positive results, confirmation of positive results should be considered using a second, different IgG assay
• Calibrator A contains phosphate buffer and protein (bovine) stabilizer
• Calibrators B through 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 ARCHITECT i System IFU
• AdviseDx SARS-CoV-2 IgG II Recipients Fact Sheet
• AdviseDx SARS-CoV-2 IgG II Healthcare Providers Fact Sheet