Beckman Coulter Reagent Kit Access® Antibody Test SARS-CoV-2 IgG For use with Access Family of Immunoassay Systems 200 Tests 20 µL Sample Volume - KT/1 - C58961-KT

Beckman Coulter Reagent Kit Access® Antibody Test SARS-CoV-2 IgG For use with Access Family of Im...

Features

• The Access 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
• Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate or high complexity tests
• The Access 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
• 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 the Access SARS-CoV-2 IgG assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes
• The Access SARS-CoV-2 IgG assay is designed to target antibodies against the coronavirus spike protein that may be more likely to confer immunity
• The Access SARS-CoV-2 IgG assay can be run in random access mode, seamlessly integrating into current laboratory workflow without the need for batching or special maintenance
• Time-to-first result (approx.): 25 minutes