Access SARS-CoV-2 IgG II Assay, a semi-quantitative COVID-19 serology tool

Driving the path forward to end the coronavirus pandemic

By integrating a semi-quantitative SARS-CoV-2 antibody assay into the routine workflow, clinicians can establish a baseline to evaluate an individual’s immune status based on the numerical value and assess relative changes in an individual’s response to the SARS-CoV-2 virus over time.

This product may not be available in your country or region at this time. Please contact your Beckman Coulter sales representative or distributor for more information.

A New Assay in the COVID-19 Toolbox

Access SARS-CoV-2 IgG II is a semi-quantitative assay that measures a patient’s level of antibodies in response to a previous SARS-CoV-2 infection, providing a numerical result in arbitrary units (AU) from 2.00-450 AU/mL1 and a qualitative result reported as non-reactive (<10AU/mL) or reactive (>/=10AU/mL) to SARS-CoV-2.

With a semi-quantitative COVID-19 IgG antibody assay, clinicians can:

  • Establish a baseline to evaluate an individual’s immune status based on a numerical value
  • Assess relative changes of an individual’s response to SARS-CoV-2 over time
  • Study the relevance of different levels of IgG antibodies2

 

Always, Quality First

  • The positive percent agreement (PPA) of the Access SARS-CoV-2 IgG II assay is 96.0% at 8-14 days post symptom onset
  • The negative percent agreement (NPA) of the Access SARSCoV-2 IgG assay is 99.9% evaluated in a study with 1,448 samples. This high NPA leads to low false positive rates, allowing clinicians to deliver highly accurate results about immune response to the SARS-CoV-2 virus
  • High Specificity of 99.9% Minimizes Inaccurate Results

    The Center for Disease Control (CDC) Recommends three strategies to improve positive predictive value3:

    Choose a test with a high specificity test persons with a history of COVID-19 Employ an orthogonal testing algorithm
    "We selected the Beckman Coulter Access SARS-CoV-2 IgG antibody assay to be the backbone of Henry Ford's COVID-19 serology testing program because of its outstanding performance in our rigorous independent evaluation."
    Dr. Bernard C Cook
    Division Head of Chemistry-Pathology
    Henry Ford Health System

    Assay Format 2x100 determinations
    Calibrator Format S0-S5, 1 vial/kit, 2mL/vial
    QC Format QC1-QC2, 3 vials/kit, 4mL/vial
    Sample volume 20uL
    Open pack stability 28 days
    Calibration stability 28 days
    Time-to-first result (approx.) 32 minutes

    Access SARS-CoV-2 IgG II New Product Information Package

    To download all technical documents needed for assay implementation, please log in to access launch documents below:

    Access SARS-CoV-2 IgG II New Product Information Package - English

    If you have any questions about the Access SARS-CoV-2 IgG II Antibody Test or the supporting procedural and technical documents, please contact Beckman Coulter technical support.

    Access Family of Immunoassay Systems
    Assay Protocol File (APF) Download

    Please review the APF Web Download Installation Instructions prior to installing the APF on your system.

    Note: The APF web download is not available for the UniCel DxC 600i system at this time.

    1The result will be displayed as non-reactive (<10AU/mL) and reactive (>/=10AU/mL.)
    2 At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity
    3Information for Laboratories about Coronavirus (COVID-19). (2020, February 11). Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibodytests-guidelines.html