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

VITROS™ Anti-SARS-CoV-2 IgG test is used for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

Supplier:  Ortho-Clinical Diagnostics™ 6199919

Catalog No. 23-610-519

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

Specifications

• Content And Storage: 2°C to 8°C
• Packaging Type: 1 Kit
• Test Time: 48 min.

• Sample Type: Serum
• Sample Size: 20 μL
• Validated Application: Assesses immune response by qualitatively measuring IgG antibodies to SARS-CoV-2

Safety and Handling

ShelfLife : Unopened: Expiration Date; Opened: ≤8 Weeks