Access SARS-CoV-2 IgG Antibody Test

Driving the path forward to end the coronavirus pandemic

By integrating high-quality antibody testing into their routine workflow, laboratories of all sizes can help identify front-line healthcare providers, patients, and community populations who have potentially developed an immune response to the SARS-CoV-2 virus. Armed with this insight, individuals with coronavirus antibodies can make informed decisions about returning to work and other activities.

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.

Antibody testing could be a vital tool for determining who has already been infected and might have immunity to the virus. Serology testing for SARS-CoV-2 is at increased demand in order to better quantify the number of cases of COVID-19, including those individuals who may be asymptomatic or have recovered.

The U.S. Food and Drug Administration (FDA) has said there are three use cases for serological tests:

  • They could one day help support decision making as to whether people can return to work
  • They could determine the people who may qualify for a vaccination once it is available
  • They could identify individuals who have recovered to see if they can donate plasma that may be used as a treatment for people with severe forms of the disease caused by the novel coronavirus

Accurate and Reliable Coronavirus Antibody Results That Clinicians Can Trust

The Access SARS-CoV-2 IgG antibody test features market-leading sensitivity and specificity. Sensitivity and specificity matter because tests without extremely high accuracy could lead to large numbers of incorrect results, potentially resulting in dangerous consequences.

Why add the Access coronavirus antibody test to your laboratory’s test menu?

  • The Access SARS-CoV-2 IgG assay is being validated against over 1,000 negative broad population-based samples—significantly more than the number of samples required by the FDA for Emergency Use Authorization
  • 100% sensitivity and 99.8% specificity—one of the highest dual rates for SARS-CoV-2 antibody tests in the market
  • Releasing a standalone SARS-CoV-2 IgG test and not a combined IgG-IgM may be more clinically informative

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 assay is designed to target antibodies against the coronavirus spike protein that may be more likely to confer immunity.
  • 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 assay detects antibodies to the RBD (Receptor Binding Domain) of the spike protein, which may be important for immunity, based on laboratory studies
  • In addition, studies show that antibodies against the RBD are neutralizing, which may indicate that these proteins are an effective measure of immunity when compared to antibodies against other SARS-CoV-2 viral proteins

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 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 assay empower your laboratory to fight the coronavirus pandemic?

  • Access SARS-CoV-2 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 C0-C1, 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.) 25 minutes

Access SARS-CoV-2 IgG Information Package

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

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

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

>18 days between positive PCR & sample collection; for sensitivity analysis, a total of 247 samples were collected from 192 individual patients.


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