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

Features

• The Dimension Vista® SARS‑CoV‑2 IgG (COV2G) 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
• Use of this test is limited to laboratories certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA) that meet requirements to perform moderate- or high-complexity testing
• The Dimension Vista® SARS‑CoV‑2 IgG (COV2G) assay is a chemiluminescent immunoassay intended for qualitative and semiquantitative detection of IgG antibodies to SARS‑CoV‑2 in human serum and plasma (dipotassium EDTA and lithium heparin) using the Dimension® Vista® System
• Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
• Results from antibody testing should not be used to diagnose or exclude acute SARS‑CoV‑2 infection
• Positive results may be due to past or present infection with non‑SARS‑CoV‑2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E
• Negative results do not preclude acute SARS‑CoV‑2 infection. If acute infection is suspected, direct testing for SARS‑CoV‑2 is necessary
• The sensitivity of the Dimension Vista® SARS‑CoV‑2 IgG (COV2G) assay early after infection is unknown
• This test has been authorized only for detecting the presence of IgG antibodies against SARS‑CoV‑2, not for any other viruses or pathogens
• Dimension Vista COV2G Flex Reagent Cartridge: 4 x 60 Tests

More Information

• Dimension Vista SARS-CoV-2 IgG FDA EUA Letter
• Dimension Vista SARS-CoV-2 IgG Assay IFU
• Dimension Vista SARS-CoV-2 IgG Assay Healthcare Providers Fact Sheet
• Dimension Vista SARS-CoV-2 IgG Assay Patients Fact Sheet