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

Used for the qualitative measurement of total antibody (including IgG and IgM) to SARS-CoV-2 in human serum and plasma (K2 EDTA) samples from patients suspected of COVID-19 by a healthcare provider, using VITROS™ ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS™ 5600/XT 7600 Integrated Systems.

Supplier:  Ortho-Clinical Diagnostics™ 6199922

Catalog No. 23-610-516

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

Specifications

• Content And Storage: 2°C to 8°C
• For Use With (Equipment): VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems
• Sample Size: 80 μL

• Sample Type: Serum, K2 EDTA Plasma
• Quantity: 1 Kit
• Validated Application: Detection of total SARS-CoV-2 antibodies

Safety and Handling

ShelfLife : Unopened: Expiration Date; Opened ≤8 Weeks