Antibody Test Control Set Abbott 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
• 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 SARSCoV-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 human-sourced materials used in the controls have been tested and found to be reactive for anti-SARS-CoV-2 IgG and nonreactive for HBsAg, HIV-1 RNA or HIV-1 Ag, anti-HIV-1/HIV-2, and anti-HCV
• 1 X 4 mL negative control; 1 X 4 mL positive control
• For In Vitro use; Rx only

More Information

• SARS-CoV-2 IgG FDA EUA Letter
• SARS-CoV-2 IgG Patient Fact Sheet
• SARS-CoV-2 IgG Health Care Provider Fact Sheet
• SDS