Antibody Test Control Set Vitros® Anti-SARS-CoV-2 Total N Antibody Positive Level / Negative Level 3 X 2 mL

Features

• The Vitros Anti-SARS-CoV-2 Total N Antibody test is only for use under the Food and Drug Administration's Emergency Use Authorization: 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
• For use in monitoring the performance of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N test when used on the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems
• 3 sets of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Controls 1 and 2 (defibrinated human plasma with anti-microbial agent, 2 mL); control 1 is non-reactive and Control 2 is reactive
• 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

More Information

• Vitros Anti-SARS-CoV-2 Total N Antibody Test FDA EUA Letter
• Vitros Anti-SARS-CoV-2 Total N Antibody Test Control IFU