Immunoassay Reagent Dimension Vista® SARS-CoV-2 Total For Dimension Vista System 240 Tests

Features

• The Dimension Vista® SARS‑CoV‑2 Total antibody assay (COV2T) 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, to perform moderate or high complexity tests
• Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
• The sensitivity of the Dimension Vista® SARS‑CoV‑2 Total antibody assay (COV2T) early after infection is unknown; 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 Dimension Vista® SARS‑CoV‑2 Total antibody assay (COV2T) may occur due to cross‑reactivity from pre‑existing antibodies or other possible causes
• The Dimension Vista® SARS‑CoV‑2 Total antibody assay (COV2T) is for in vitro diagnostic use in the qualitative detection of total antibodies (including IgG and IgM) to SARS‑CoV‑2 in human serum and plasma (dipotassium EDTA and lithium heparin) using the Dimension Vista® System
• This assay is intended as an aid in identifying individuals with an adaptive immune response to SARS‑CoV‑2, indicating recent or prior infection
• The Dimension Vista® SARS‑CoV‑2 Total antibody assay (COV2T) should not be used to diagnose acute SARS‑CoV‑2 infection
• 16 minutes time to first result

More Information

• Dimension Vista SARS-CoV-2 Total Antibody IFU
• Dimension Vista SARS-CoV-2 Total Antibody FDA EUA Letter
• Dimension Vista SARS-CoV-2 Total Antibody Healthcare Providers Fact Sheet
• Dimension Vista SARS-CoV-2 Total Antibody Recipients Fact Sheet