QuidelOrtho VITROS™ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator

Description

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.

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 Immunodiagnostic 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.

Calibrator Contents:

• 2 vials of VITROS™ Anti‐SARS-CoV-2 IgG Calibrator (anti-SARS-CoV-2 IgG in anti-SARS-CoV-2 IgG negative human serum with antimicrobial agent, 1 mL)
• Lot calibration card
• Protocol card
• 8 calibrator bar code labels

Materials Required but Not Provided:

• VITROS™ Immunodiagnostic Products Signal Reagent
• VITROS™ Immunodiagnostic Products Universal Wash Reagent
• VITROS™ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack (Part No. 6199919)
• 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
• For Use With (Equipment): VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems
• Sample Type: Serum
• For Use With (Application): Assesses immune response by qualitatively measuring IgG antibodies to SARS-CoV-2
• Packaging: 2 Vials