Ortho-Clinical Diagnostics™ VITROS™ Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack

Description

• The VITROS™ Immunodiagnostic Products Anti-SARS-CoV-2 Total test is performed using the VITROS™ Anti-SARS-CoV-2 Total Reagent Pack and the VITROS™ Anti-SARS-CoV-2 Total Calibrator on the VITROS™ ECi/ECiQ/3600 Immunodiagnostic System and the VITROS™ 5600/XT 7600 Integrated Systems
• An immunometric technique is used; this involves a two stage reaction: In the first stage antibodies to SARS-CoV-2 present in the sample bind with SARS-CoV-2 spike protein antigen coated on the well
• Unbound sample is removed by washing
• In the second stage horseradish peroxidase (HRP)-labeled recombinant SARS-CoV-2 antigen is added in the conjugate reagent
• The conjugate binds specifically to any anti-SARSCoV-2 captured on the well in the first stage
• Unbound conjugate is removed by the subsequent wash step
• The bound HRP conjugate is measured by a luminescent reaction
• A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent is added to the wells
• The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light
• The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission
• The light signals are read by the system
• The amount of HRP conjugate bound is indicative of the amount of SARS-CoV-2 antibody present
• Reagent Pack Contents (Part No
• 6199922): 1 reagent pack containing: 100 coated wells (streptavidin, bacterial; binds ≥ 3 ng biotin per well; biotin recombinant SARS-CoV-2 antigen 0.1 μg/mL) 6.0 mL assay reagent (buffer with bovine protein stabilizers and antimicrobial agent) 16.2 mL conjugate reagent (HRP-recombinant SARS-CoV-2 antigen, 0.5 μg/mL) in buffer with bovine protein stabilizers and antimicrobial agent Required but not included: VITROS™ Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator (Part No
• 6199923) Quality control materials such as VITROS™ Immunodiagnostic Products Anti‑SARS-CoV-2 Total Controls (Part No
• 6199924) VITROS™ Immunodiagnostic Products Signal Reagent VITROS™ Immunodiagnostic Products Universal Wash Reagent VITROS™ Immunodiagnostic Products Reagent Pack Storage Box (optional) with desiccant