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

Description

• The VITROS™ Immunodiagnostic Products Anti-SARS-CoV-2 IgG test is performed using the VITROS™ Anti-SARS-CoV-2 IgG Reagent Pack and the VITROS™ Anti-SARS-CoV-2 IgG Calibrator on the VITROS™ ECi/ECiQ/3600 Immuanodiagnostic Systems 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 coated on wells
• Unbound sample is removed by washing
• In the second stage horseradish peroxidase (HRP)-labeled murine monoclonal anti-human IgG antibodies are added in the conjugate reagent
• The conjugate binds specifically to the antibody portion of the antigen-antibody complex
• If complexes are not present, the 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 IgG antibody present
• Reagent Pack Contents 1 reagent pack containing: 100 coated wells (recombinant SARS-CoV-2 antigen derived from human cells, coated at 110 ng/well) 18.0 mL assay reagent (buffer with bovine protein stabilizers and antimicrobial agent) 20.4 mL conjugate reagent [anti-human IgG (murine monoclonal) conjugated to horseradish peroxidase, 5 ng/mL] in buffer with bovine protein stabilizers and antimicrobial agent Materials Required but Not Provided: VITROS™ Immunodiagnostic Products Signal Reagent VITROS™ Immunodiagnostic Products Universal Wash Reagent VITROS™ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator (Part No
• 6199920) Quality control materials such as VITROS™ Immunodiagnostic Products VITROS™ Anti‐SARS-CoV-2 IgG Controls (Part No. 6199921) VITROS™ Immunodiagnostic Products Reagent Pack Storage Box (optional) with desiccant