Antibody Test Control Set Vitros® Anti-SARS-CoV-2 Total Positive Level / Negative Level 3 X 1 mL

Features

• For use under an Emergency Use Authorization (EUA) Only : 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
• Results are for the detection of total SARS-CoV-2 antibodies; reactive results could occur after infection and can be indicative of acute or recent infection
• Laboratories within the United States and its territories are required to report all reactive results to the appropriate public health authorities
• Non-reactive results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions; results must be combined with clinical observations, patient history, and epidemiological information
• VITROS Anti‑SARS-CoV-2 Total Controls 1 and 2 contain: SARS-CoV-2 antibody negative plasma obtained from donors who were tested individually and who were found to be negative for hepatitis B surface antigen, and for antibodies to hepatitis C virus (HCV) and HIV, using approved methods (enzyme immunoassays)
• VITROS Anti‑SARS-CoV-2 Total Control 2 in addition contains: SARS-CoV-2 antibody; handle as if capable of transmitting infection
• Includes: 3 sets of VITROS Anti-SARS-CoV-2 Total Controls 1 and 2 (human matrix with anti-microbial agent, 1 mL)ARS-CoV-2 Total Control 2 in addition contains: SARS-CoV-2 antibody; handle as if capable of transmitting infection
• Supplied ready-to-use

More Information

• Vitros Anti-SARS-CoV-2 Total Controls IFU
• Ortho-Clinical Vitros FDA Emergency Use Authorization Letter
• Vitros Anti-SARS-CoV-2 Health Care Providers Fact Sheet
• Vitros Anti-SARS-CoV-2 Patient Fact Sheet