Immunoassay Reagent Dimension® EXL™ SARS-CoV-2 Total For Dimension EXL 200 / EXL LM 320 Tests

Features

• The Dimension® EXL™ SARS‑CoV‑2 Total antibody assay (CV2T) is for use under FDA Emergency use Authorization 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
• 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® EXL™ SARS‑CoV‑2 Total antibody assay (CV2T) 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 Total antibody assay (CV2T) may occur due to cross‑reactivity from pre‑existing antibodies or other possible causes Dimension® EXL™ SARS‑CoV‑2 Total antibody assay (CV2T) 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® EXL™ integrated chemistry system with LOCI® Module This assay requires 10 µL of serum or plasma for a single determination 16 minutes time to first result