Beckman Coulter Launches A Fully Quantitative and Automated COVID-19 IgG Test to Assess Antibody Immune Response Levels


  • The availability of an International Standard (IS) for antibodies facilitates the standardization of SARS-CoV-2 serological methods
  • Access SARS-CoV-2 IgG (1st IS) measures the quantity of antibodies so physicians can determine an individual’s COVID-19 antibody immune response and aids in the monitoring of patients who were previously diagnosed.
  • High-quality test has a PPA ≥15 days post-symptom onset of 100% and NPA of 99.8% and delivers results traceable to 1st WHO International Standard for anti-SARS-CoV-2, 20/136
  • Available to all customers in countries accepting the CE mark and to customers throughout the U.S. and Puerto Rico under FDA Policy D

BREA, CALIF., MAY. 19, 2021 — Beckman Coulter, a global clinical diagnostics leader, today announced the launch of Access SARS-CoV-2 IgG (1st IS), a fully-quantitative lab-based Immunoglobulin G (IgG) serology test that measures the quantity of antibodies against the virus that causes COVID-19. The newest addition to its suite of COVID-19 solutions, this high-quality assay is traceable to the 1st WHO International Standard for anti-SARS-CoV-2, 20/136 and reports results directly aligned with BAU/mL (Binding Antibody Units) established by the World Health Organization. As the pandemic continues its global assault, serology testing is emerging as a test with public health and clinical utility for monitoring and responding to the COVID-19 pandemic and caring for patients1.

“Serology testing has wide-ranging clinical utility. For example, according to the CDC, antibody testing may be useful to provide evidence of a previous COVID-19 infection,” said Shamiram R. Feinglass, M.D., MPH, chief medical officer for Danaher Diagnostics and Life Sciences. “With a quantitative assay such as the IgG (1st IS), physicians can now compare results to a standard and look across populations.”

The Clinical Utility of COVID-19 Serology Testing

Beckman Coulter launched its first COVID-19 IgG and IgM tests in 2020 during the initial outbreak. The tests were designed to qualitatively detect antibodies produced against the spike protein of the SARS-CoV-2 virus. Following the launch, the company delivered highly accurate IgG and IgM tests to provide reliable information for both individual health decisions as well as population-based monitoring.

Chart showing COVID-19 test types measured by time intervals and detection rates vs response curve

A menu that matters in the fight against COVID-19. Graphic developed with supporting evidence
(Source: Guglielmi, G. (2020). Fast coronavirus tests: what they can and can’t do. Nature, 585(7826), 496–498.)

"These assays are going to help physicians better understand the immune response of patients who develop COVID-19 infections."
Dr. Bernard Cook
Division Head of Chemistry and Director of Operations of the Core Automated Laboratory
Henry Ford Hospital

About Beckman Coulter
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation (NYSE: DHR) since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.

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1CDC. (2021, March 17). Interim guidelines for COVID-19 antibody testing. Retrieved March 23, 2021, from CDC.gov website: https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html
*Currently available in the U.S., pending CE registration