Calibrator Kit Vitros® Anti-SARS-CoV-2 IgG 2 X 1 mL For use with Anti-SARS-CoV-2 IgG Test on Vitros ECi / ECiQ (Available End of May 2020) / Vitros 3600 / 5600 / XT7600 Liquid

Features

• The VITROS Anti-SARS-CoV-2 IgG test 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. section 263a
• to perform moderate and 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 VITROS Anti-SARS-CoV-2 IgG test in early 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 VITROS Anti-SARS-CoV-2 IgG test may occur due to cross-reactivity from pre-existing antibodies or other possible causes VITROS Anti-SARS-CoV-2 IgG test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2
• indicating recent or prior infection At this time
• it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity VITROS Anti-SARS-CoV-2 IgG test should not be used to diagnose acute SARS-CoV-2 infection VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack when used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator is a chemiluminescent immunoassay test intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum VITROS Anti‑SARS-CoV-2 IgG Calibrator is suitable for use until the expiration date on the carton when stored and handled as specified; do not use beyond the expiration date The VITROS Anti‑SARS-CoV-2 IgG test uses 20 μL of calibrator for each determination VITROS Anti‑SARS-CoV-2 IgG Calibrator is supplied ready to use