Reagent Kit Vitros® Antibody Test Anti-SARS-CoV-2 Total N Antibody For VITROS ECi / ECiQ / 3600 Immunodiagnostic Systems and the VITROS 5600 / XT 7600 Integrated Systems 80 µL Sample Volume

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate or high complexity tests

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Reagent Pack when used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators is a chemiluminescent immunoassay test intended for the qualitative detection of total antibody (including IgG, IgA and IgM) to SARS-CoV-2 nucleocapsid protein in human serum and plasma (K2 -EDTA)

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 Total N Antibody 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 Total N Antibody 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

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 (streptavidin, bacterial; binds ≥ 3 ng biotin per well; recombinant SARS-CoV-2 nucleocapsid antigen 14 ng/well), 6.0 mL assay reagent (buffer with bovine protein stabilizers and antimicrobial agent), 16.2 mL conjugate reagent (HRP-recombinant SARS-CoV-2 nucleocapsid antigen) in buffer with bovine protein stabilizers and antimicrobial agent