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

Driving the path forward in the fight against COVID

By integrating a semi-quantitative SARS-CoV-2 antibody assay into the routine workflow, clinicians can establish a baseline to evaluate an individual’s adaptive immune 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.

Another 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 adaptive immune response based on a numerical value
  • Assess an immune response to SARS-CoV-2 over time

 

Always, Quality First

  • The positive percent agreement (PPA) of the Access SARS-CoV-2 IgG II assay is 98.9% ≥ 15 days post symptom onset
  • The overall negative percent agreement (NPA) of the Access SARS-CoV-2 IgG II assay is 100%
  • High Specificity of 100% 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
    "Serological tests can play a critical role in the fight against COVID-19 by helping healthcare professionals to identify individuals who have overcome an infection in the past and have developed an immune response.4"
    STEPHEN M. HAHN, M.D.
    COMMISSIONER OF FOOD AND DRUGS
    U.S. FOOD AND DRUG ADMINISTRATION

    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.)
    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
    4https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-serological-tests