Immunoassay Reagent Abbott SARS-CoV-2 IgG For Architect i Systems 100 Tests

Features

• The SARS-CoV-2 IgG assay 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 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 Kit contents include: (100) Tests
• 6.6 mL Microparticles
• 5.8 mL Conjugate
• 7.9 mL Assay Diluent