General Chemistry Reagent Dimension® EXL™ SARS-CoV-2 IgG For Dimension EXL Integrated Chemistry System with LOCI Module 480 Tests

Features

• The Dimension® EXL™ SARS‑CoV‑2 IgG (CV2G) 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 (CLIA) of 1988, 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests
• The Dimension® EXL™ SARS‑CoV‑2 IgG (CV2G) 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® EXL™ integrated chemistry system with LOCI® Module
• Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
• The sensitivity of the Dimension® EXL™ SARS‑CoV‑2 IgG (CV2G) assay 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® EXL™ SARS‑CoV‑2 IgG (CV2G) assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes
• Results are for the detection of SARS‑CoV‑2 IgG antibodies; IgG antibodies to SARS‑CoV‑2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post‑infection is not well characterized
• Dimension EXL CV2G Flex Reagent Cartridge: 8 X 60 Tests

More Information

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