Access SARS-CoV-2 IgG (1st IS) Assay

Driving the path forward to end the coronavirus pandemic

By integrating a quantitative SARS-CoV-2 antibody assay into the routine workflow, clinicians can establish a baseline to evaluate an individual’s antibody immune response. Access SARS-CoV-2 IgG (1st IS) is traceable to the 1st WHO International Standard for anti-SARS-CoV-2, 20/136.

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.

Serology or antibody testing as a clinical tool may aid with determining who has developed an adaptive immune response to SARS-CoV-2 either from recent or previous infection.

Traceable to the First WHO International Standard

The availability of an International Standard (IS) for antibodies facilitates the standardization of SARS-CoV-2 serological methods and allows for comparison of datasets across laboratories. Standardization against an international reference allows for the accurate calibration of assays, reducing interlaboratory variations and creating a common language for reporting results. This will help determine the antibody response in the development of vaccines and therapeutics, and improve our understanding of virus epidemiology.

Alignment with an international standard can assist in comparison of assays detecting the same class of immunoglobulins with the same specificity (e.g. anti-receptor binding domain IgG). Manufacturers reagents are recommended to be calibrated to the IS acknowledging the different antigen targets and that they may have different potencies of neutralizing and binding antibody recognition. Results will be expressed In International Unit per milliliter (IU/mL). 

Accurate and Reliable Coronavirus Antibody Results That Clinicians Can Trust

Results are specific to IgG antibodies

Quantitative and qualitative assay allows to establish Ab baseline and assessment of titer changes over time to understand durability of immune response:

  • PPA: 100% (95% CI: 95.1 - 100.0%) ≥ 15 days post-symptom onset 
  • NPA: 99.8% (95% CI: 99.4 - 99.9%)

High Medical Value with Targeted Antibody Identification

To identify an immune response against the SARS-CoV-2 coronavirus, it is important to target the right antibodies.

  • The Access SARS-CoV-2 IgG (1st IS) assay is designed to target antibodies against the coronavirus spike protein that may be more likely to confer an immune response.
  • Laboratory studies show that to identify an immune response against the SARS-CoV-2 coronavirus, it is important to target the right antibodies
  • The Access SARS-CoV-2 IgG (1st IS) assay detects antibodies to the RBD (Receptor Binding Domain) of the spike protein

Novel Coronavirus Structure

Illustration of coronavirus with four structural proteins

Figure 1. A coronavirus contains four structural proteins, including spike (S), envelope (E), membrane (M) and nucleocapsid (N) proteins. 

Seamless Integration with Routine Lab Workflow

The Access SARS-CoV-2 IgG (1st IS) assay can be run in random access mode, seamlessly integrating into current laboratory workflow without the need for batching or special maintenance. This can help your laboratory experience industry-leading system uptime.

How else can the Access SARS-CoV-2 IgG (1st IS) assay empower your laboratory to fight the coronavirus pandemic?

  • Access SARS-CoV-2 antibody test throughput on Beckman Coulter immunoassay and integrated systems leads the industry at up to 200 tests per hour depending on the analyzer used (up to 4,800 tests/day)
  • QC procedures only need to be run once every 24 hours, or as required by individual laboratory procedure, and the assay comes in 200 tests/kit, requiring less frequent ordering
  • REMISOL Advance middleware provides patient results from both diagnostic and serology tests on one screen to help improve laboratory efficiency

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.) 30 minutes

Access SARS-CoV-2 IgG 1st IS 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 1st IS New Product Information Package - English

If you have any questions about the Access SARS-CoV-2 IgG 1st IS 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.

This test has not been reviewed by the FDA. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high complexity tests.

The positive percent agreement was evaluated in 170 individual samples from symptomatic patients diagnosed with SARS-CoV-2 by PCR from the Dominican Republic, France, Peru and the United States.

REMISOL Advance is a trademark or registered trademark of Normand-Info SAS in the United States and other countries. Used under license.