VITROS Anti-SARS-CoV-2 IgG Quantitative Antibody test is for use under an FDA EUA: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-serology-and-other-adaptive-immune-response-tests-sars-cov-2
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high-complexity tests
The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack when used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Calibrators is a chemiluminescent immunoassay test intended for the qualitative and quantitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma (EDTA and lithium heparin)
The VITROS Anti-SARS-CoV-2 IgG Quantitative test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2
Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
The sensitivity of VITROS Anti-SARS-CoV-2 IgG Quantitative test in early infection is unknown; negative results do not preclude acute SARS-CoV-2 infection
False positive results for VITROS Anti-SARS-CoV-2 IgG Quantitative test may occur due to cross-reactivity from pre-existing antibodies or other possible causes
Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus; follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals
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
Kit includes: 3 sets of VITROS Anti-SARS-CoV-2 IgG QN Controls 1, 2 and 3 (matrix with anti-microbial agent, 2 mL)

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