Beckman Coulter launches its SARS-CoV-2 IgM antibody test in countries accepting CE Mark and will begin shipping to diagnostics labs

Assay has 99.9% specificity and 98.3% sensitivity at 15-30 days post-symptom onset and confirmed 95.5% positive predictive value when disease incidence is as low as 3%

Beckman Coulter developed separate SARS-CoV-2 Immunoglobulin M (IgM) and SARS-CoV-2 Immunoglobulin G (IgG) antibody assays to better help clinicians determine a patient's immune status in response to a recent or past infection

Additional COVID-19 testing solutions coming to market* to guide clinical and public health decision making include a SARS-CoV-2 antigen and quantitative IgG assay

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Beckman Coulter Diagnostics

Nov 10, 2020, 03:00 ET

HIGH WYCOMBE, England, Nov. 10, 2020 /PRNewswire/ -- Beckman Coulter, a clinical diagnostics leader, today announced the launch of its Access SARS-CoV-2 Immunoglobulin M (IgM) assay in countries accepting the CE Mark. The new IgM antibody test demonstrated 99.9% specificity with 1,400 negative samples and 98.3% sensitivity at 15-30 days post-symptom onset. Beckman Coulter's IgM assay is part of a full suite of testing solutions the company is developing to inform clinical and public health decision making during the COVID-19 pandemic. Beckman Coulter is also developing a SARS-CoV-2 antigen test and quantitative IgG assay. Beckman Coulter's antibody assays and its other planned SARS-CoV-2 offerings run on the organisation's award-winning immunoassay analysers, including the DxI 800 high-throughput analyser, which is capable of processing 200 samples per hour.

Basics of COVID-19 Serology, IgG and IgM Antibodies and more, with Shamiram R. Feinglass, M.D., MPH, chief medical officer Beckman Coulter.

"Our new SARS-CoV-2 IgM assay provides information about an individual's immune status with a positive predictive value of 95.5% in a population with disease incidence as low as 3%," said Julie Sawyer Montgomery, president of Beckman Coulter. "As COVID-19 outbreaks continue to grow in intensity in many of our communities, highly accurate tests such as this are critical for providing reliable information for both individual health decisions as well as population-based immunity monitoring."

The full suite of testing solutions, including the IgM & IgG assays currently available and the antigen and quantitative IgG assay under development, provide valuable information in clinical decision making for patients suffering from COVID-19. The company developed separate SARS-CoV-2 IgM and SARS-CoV-2 IgG antibody assays to help clinicians determine a patient's immune status in response to a recent or past infection. The Beckman Coulter IgM assay detects antibodies that may emerge earlier in the course of infection and then dissipate, while the IgG test detects antibodies associated with the longer-term immune response. Both IgM and IgG assays can identify antibodies in asymptomatic individuals. Since each person's seroconversion process is different, the two tests can be used together to provide the most accurate view of their immune response.

Rob Young, UK General Manager for Beckman Coulter, added: "This latest addition to our already extensive offering, which spans serological, antigen, and other diagnostic solutions, brings greater visibility to help monitor the progression of COVID-19 in patients. We continue to innovate and provide a multitude of high-quality tests in high volumes to help clinicians identify patients with the virus and support efforts in fighting the disease."

Around the world, diagnostic labs are under immense pressure to be more efficient when it comes to meeting testing demands. Beckman Coulter's assays can be performed in automated or high-throughput immunoassay formats. The Access SARS-CoV-2 IgM test can also be run on Beckman Coulter's Access 2 analyser, a compact, table-top analyser enabling high-quality serology testing to be carried out in small hospitals and clinics. Additionally, this test seamlessly integrates into laboratory workflows, making it easy to add serology testing to routine blood tests performed during inpatient and wellness testing.

Able to deliver more than 15 million tests each month, the company can meet its customers' global demands, including more than 16,000 immunoassay analysers worldwide. For more information on Beckman Coulter's suite of testing solutions or its commitment to the fight against COVID-19, visit www.BeckmanCoulter.com/Coronavirus.

About the Access SARS-CoV-2 IgM Assay
The Access SARS-CoV-2 IgM Assay is a qualitative immunoassay that detects IgM antibodies. The test has confirmed 98.3% positive percent agreement (sensitivity) at 15-30 days post symptom onset and 99.9% negative percent agreement (specificity). The assay utilises an immunocapture format to bind patient IgM antibodies on the magnetic particle solid phase and a recombinant SARS-CoV-2 protein - enzyme conjugate to detect anti-SARS-CoV-2 IgM. The Access SARS-CoV-2 IgM assay can be used in Random Access Mode (RAM), which means that the antibody tests can be run along with other immunoassay tests. The assay can also be used with a variety of Beckman Coulter analysers, including the high-throughput DxI 800 designed for large labs, the DxI 600 for mid-sized labs and the DxC 600i and Access 2 analysers for smaller labs and healthcare clinics.

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, California, and has more than 11,000 global associates working diligently to make the world a healthier place.

*The SARS-CoV-2 antigen assay and SARS-CoV-2 IgG quantitative assay are currently under development, have not yet received the CE Mark and are not yet available for sale in countries that accept the CE Mark.

© 2020 Beckman Coulter. All rights reserved. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. 2020-8328

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