Reagent Kit Vitros® Quantitative Antibody Test Anti-SARS-CoV-2 IgG For use with VITROS ECi / ECiQ / 3600 Immunodiagnostic Systems and the VITROS 5600 / XT 7600 Integrated Systems 20 µL Sample Volume

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

Reagent Pack contains: 100 coated wells (recombinant SARS-CoV-2 antigen derived from human cells, coated at 110 ng/well), 18.0 mL assay reagent (buffer with bovine protein stabilizers and antimicrobial agent), 20.4 mL conjugate reagent [anti-human IgG (murine monoclonal) conjugated to horseradish peroxidase, 5 ng/mL] in buffer with bovine protein stabilizers and antimicrobial agent

100% specificity (95% CI: 99.3-100%) tested on 533 presumed negative blood donor samples collected prior to the COVID-19 pandemic

92.4% sensitivity and positive agreement on samples from 264 discrete individuals confirmed positive to COVID-19 by PCR tested greater than 15 days after symptom onset