Beckman Coulter Launches First 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, or suspected of having COVID-19
• High-quality test has a PPA/sensitivity ≥15 days post-symptom onset of 100% and NPA/specificity 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 /PRNewswire/ -- Beckman Coulter, a global clinical diagnostics leader, today announced the launch of Access SARS-CoV-2 IgG (1^st 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, even while vaccinations are being rolled out, 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 patientsⁱ.

“Serology testing has wide-ranging clinical utility currently, as well as in a post-vaccinated world. For example, according to the CDC, antibody testing may be useful to support a diagnosis of a previous COVID-19 illness,” 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 as they were strongly suspected to be neutralizing. 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 immunity monitoring.

“With the launch of a fully quantitative COVID-19 IgG assay, we [can] determine seroprevalence in a population and also help determine the quantity of antibodies in individuals over time, which wasn’t possible before because we didn’t have standardization across quantitative serology tests,” said Dr. Bernard Cook, division head of chemistry and director of operations of the core automated laboratory, Henry Ford Hospital in Detroit. “Now, and in a post-vaccinated world, these assays are going to help physicians better understand the immune response of patients who develop COVID-19 infections, those who have post-acute sequelae of COVID-19 and in assessing response to vaccination to SARS-CoV-2.”

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

In a clinical study, Beckman Coulter’s Access SARS-CoV-2 IgG (1^st IS) quantitative test showed a clinical performance of 100% Positive Percent Agreement/Sensitivity (exclusion of false negatives) and 99.8% Negative Percent Agreement/Specificity (exclusion of false positives) in patients tested >/=15 days or more post-symptom onset.

“Laboratory testing remains a powerful tool in our fight against the pandemic,” said Chris Hagen, global vice president of the COVID-19 task force at Beckman Coulter. “The Access SARS-CoV-2 IgG (1st IS) assay may be used to inform clinicians about changes in antibody levels over time. This virus continues to evolve, which is why we are continually developing diagnostic solutions to help physicians save lives.”

Beckman Coulter has more than 16,000 immunoassay analyzers worldwide. Just like all of Beckman Coulter’s COVID-19 assays, the Access SARS-CoV-2 IgG (1^st IS) test can be used in Random Access Mode (RAM) and seamlessly integrated into existing workflows without batch processing. Results of the new quantitative antibody test are delivered quickly on Beckman Coulter’s award-winning immunoassay analyzers, including the DxI 800 high-throughput analyzer, which is capable of processing up to 200 Access SARS-CoV-2 IgG (1^st IS) samples per hour.

Access SARS-CoV-2 IgG (1^st IS) can be immediately shipped to customers in countries accepting the CE mark and to customers throughout the U.S. and Puerto Rico under the U.S. Food and Drug Administration’s (FDA) Policy D. The company has filed for Emergency Use Authorization of the assay with FDA.

Important Resources

Learn more about Beckman Coulter’s suite of COVID-19 solutions at our website www.beckmancoulter.com/coronavirus

Learn about Access SARS CoV-2 IgG (1st IS) at www.beckmancoulter.com/igg1stIS

Access the COVID-19 media kit, which contains product videos, articles and other assets at https://www.beckmancoulter.com/igg1stIS-media

Learn more COVID-19 antibody testing by watching these educational videos:

• Antibody Testing: IgG and IgM explained
• COVID-19 and Antibody tests explained: IgM and IgG antibodies to Coronavirus
• SARS-CoV-2 IgG antibodies and why the receptor-biding domain of the spike protein is so important

Beckman Coulter’s Suite of COVID-19 Testing Solutions

Beckman Coulter offers a menu that matters for COVID-19, including the $4 Access SAR-CoV-2 Antigen assay* as well as four antibody assays: Access SARS-CoV-2 IgM, Access SARS CoV-2 IgG, the semi-quantitative SARS-CoV-2 IgG II and Access SARS-CoV-2 IgG (1^st IS).

The company also has an interleukin 6 (IL-6) assay, which can be used to aid physicians in identifying a severe inflammatory response and determining the risk of intubation with mechanical ventilation in COVID-19 patients. Beckman Coulter also offers a biomarker that measures monocyte distribution width (MDW), which can be used as an aid in the early detection of sepsis in adult patients presenting to the emergency department. Earlier this year, the company received government funding to develop a machine learning algorithm to help accurately predict and detect sepsis in COVID-19 patients leveraging its MDW test. Additionally, in mid-October, Beckman Coulter was awarded funding by for a multi-center clinical trial to validate the ability of MDW to aid in the rapid detection of Multisystem Inflammatory Syndrome in Children (MIS-C), a severe COVID-19 complication.

All of Beckman Coulter’s assays developed to address COVID-19 can be performed in automated or high-throughput immunoassay formats, as well as with Beckman Coulter’s Access 2 analyzer, a compact, tabletop analyzer enabling high-quality serology testing to be carried out in small hospitals and clinics. Additionally, all of the assays seamlessly integrate into laboratory workflows making it easy to add these tests to routine blood tests performed during inpatient and wellness testing.

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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