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

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