Calibrator Kit Alinity i SARS-CoV-2 IgG For the Calibration of the Alinity i System 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