Reagent Kit Vidas® Antibody Test SARS-COV-2 IgG For use with Instruments of the VIDAS Family 60 Tests

Features

• VIDAS® SARS-COV-2 IgG Assay is 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 of 1988 (CLIA)
• 42 U.S.C 263a
• that meet requirements to perform moderate or high complexity tests The VIDAS® SARS-COV-2 IgG is an automated assay using the ELFA (Enzyme Linked Fluorescent Assay) technique intended for qualitative detection of IgG antibodies to SARS-CoV-2 in human serum or plasma (lithium heparin) on instruments of the VIDAS family The VIDAS® SARS‑COV‑2 IgG 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 VIDAS® SARS‑COV‑2 IgG may occur due to cross‑reactivity from pre‑existing antibodies or other possible causes Kit contains: 60 Strips (9COM)
• 60 Solid Phase Receptacles(9COG) 2 x 30
• Standard (9COG) 1 X 0.5 mL (liquid)
• Positive control (9COG) 1 x 0.5 mL (liquid)
• Negative Control 1 X 0.5 mL (liquid)
• and package insert