Antibody Test Control Set Alinity i SARS-CoV-2 IgG Positive Level / Negative Level 2 X 4 mL

Features

• For use under an Emergency Use Authorization (EUA) Only : https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
• 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
• Negative control contains human plasma
• Positive control contains inactivated, cell-free, human blood-derived material, reactive for anti-SARS-CoV-2 IgG
• Prescription Use only; For In Vitro Diagnostic Use Only

More Information

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