“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. “These assays are going to help physicians better understand the immune response of patients who develop COVID-19 infections.”
Access SARS-CoV-2 IgG (1st IS)
In a clinical study, Beckman Coulter’s Access SARS-CoV-2 IgG (1st IS) quantitative test showed a clinical performance of 100% Positive Percent Agreement (exclusion of false negatives) and 99.8% Negative Percent Agreement (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 (1st 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 (1st IS) samples per hour.
Access SARS-CoV-2 IgG (1st 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.
Learn more about Beckman Coulter’s suite of COVID-19 solutions at www.beckmancoulter.com/coronavirus
Lean 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 www.beckmancoulter.com/iggistIS-media
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 (1st 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.