Immunoassay Reagent Vidas® SARS-COV-2 IgM For Instruments of the VIDAS Family 60 Tests

Features

• VIDAS® SARS-COV-2 IgM 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 IgM is an automated assay using the ELFA (Enzyme Linked Fluorescent Assay) technique intended for qualitative detection of IgM antibodies to SARS-CoV-2 in human serum or plasma (lithium heparin) on instruments of the VIDAS family
• The VIDAS® SARS‑COV‑2 IgM is intended for use as an aid in identifying individuals with an adaptive immune response to SARS‑CoV‑2, indicating recent 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

More Information

• Vidas SARS-COV-2 IgM FDA EUA Letter
• Vidas SARS-COV-2 IgM Assay IFU
• Vidas SARS-COV-2 IgM Healthcare Providers Fact Sheet
• Vidas SARS-COV-2 IgM Recipients Fact Sheet