Antibody Test Control 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