Calibrator Alinity i SARS-CoV-2 IgG For the Calibration of the Alinity i Systems when used for the Qualitative Detection of IgG Antibodies to SARS-CoV-2 in Human Serum and Plasma

Features

• SARS-CoV-2 IgG test for use with Alinity i 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 SARS-CoV-2 IgG assay is intended for use as an aid in identifying individuals 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
• The SARS CoV-2 IgG assay should not be used to diagnose acute SARS-CoV-2 infection
• Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C 263a, to perform moderate or high complexity test
• Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
• 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 SARS-CoV-2 IgG assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes
• The SARS-CoV-2 IgG assay is only for use under the Food and Drug Administration’s Emergency Use Authorization
• The SARS-CoV-2 IgG Calibrator Kit is for the calibration of the Alinity i system when used for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum, serum separator tube and plasma (ACD, CPD, CPDA-1, dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin separator tube, sodium citrate, sodium heparin)
• Calibrator contains inactivated, cell-free, human blood-derived material, reactive for anti-SARS-CoV-2 IgG

More Information

• Alinity i SARS-CoV-2 IgG FDA EUA Letter
• Alinity i SARS-CoV-2 IgG Calibrator Kit IFU
• Alinity i SARS-CoV-2 IgG Patient Fact Sheet
• Alinity i SARS-CoV-2 IgG Health Care Provider Fact Sheet