Beckman Coulter launches its semi-quantitative SARS-CoV-2 IgG II antibody test

Beckman Coulter, a clinical diagnostics leader, today launched its Access SARS-CoV-2 IgG II assay that measures a patient's relative level of antibodies in response to a previous SARS-CoV-2 infection. The new capabilities of this assay enable clinicians to establish a baseline to evaluate an individual's immune response to the SARS-CoV-2 virus based on a numerical value and assess relative changes of an individual's immune response to the virus over time. The assay may also help researchers as they begin to understand the levels of IgG antibodies needed to be considered protective. 2

The organization is filing for Emergency Use Authorization of the assay with the U.S. Food and Drug Administration (FDA) and will immediately begin shipping assays to its customer base throughout the U.S. under Policy D. Beckman Coulter is also planning to make the assay available to markets accepting the CE Mark before the end of the year.

"Having a clearer picture of the immune response to SARS-CoV-2 plays an important role in the fight against COVID-19, especially before a vaccine is widely available," said Shamiram R. Feinglass , M.D., MPH, chief medical officer Beckman Coulter. "While it's unknown how long antibodies persist following infection, and if the presence of antibodies confers protective immunity, having a quantifiable baseline is a critical step towards furthering the understanding of the adaptive immune response to SARS-CoV-2 in individuals over time."

Access SARS-CoV-2 IgG II semi-quantitative assay provides a numerical result in Arbitrary Units (AU) from 2.00- 450 AU/mL ¹ as well as a qualitative result and offers the same high level of quality as Beckman Coulter's Access SARS-CoV-2 IgG and IgM serology tests already on the market. The assays use the receptor-binding domain (RBD) of the spike protein. Beckman Coulter selected the RBD of the spike protein as it is critical for viral entry into human cells and has been shown to be the target for neutralizing antibodies in a surrogate model. This selection is also aligned with the multiple vaccines in development that target or include the RBD of the spike protein, with the goal of producing protective antibodies.

The Access SARS-CoV-2 IgG II semi-quantitative assay is the latest addition to Beckman Coulter's full suite of testing solutions designed to provide valuable information to clinicians in their fight against COVID-19. The next product expected from the organization is an automated SARS-CoV-2 antigen test which is currently under development. While point of care (POC) antigen tests have a purpose in diagnosing COVID-19, they are difficult and resource intensive to scale to address high volume testing needs ³ . Beckman Coulter's antigen test is being designed to provide ultimate flexibility in scaling to address the needs of small, moderately complex laboratories that operate a desktop analyzer, to large laboratories that implement automated, high-throughput analyzers for mass testing.

About the Access SARS-CoV-2 IgG II assay
The Access SARS-CoV-2 IgG II assay is a semi-quantitative and qualitative immunoassay that measures IgG antibodies directed to the receptor-binding domain of the spike protein of the novel coronavirus in response to a previous infection. The assay then provides a numerical result ranging from 2.00-450/mL ¹ as well as a qualitative result for SARS-CoV-2 IgG antibodies.

The test has a confirmed 96.0% positive percent agreement (PPA, sensitivity) at 8-14 days post symptom onset and 99.9% negative percent agreement (NPA, specificity) evaluated in a study with 1,448 samples from donors in the U.S.A. and France collected prior to December 2019 . With this high NPA rate, false positive results are extremely low to ensure accurate and reliable test results. It uses immobilized virus antigens on magnetic particles to capture IgG antibodies from patient serum or plasma samples and reveals them using labelled anti-IgG antibodies.

The Access SARS-CoV-2 IgG II assay can be used can be used in Random Access Mode (RAM) and seamlessly integrated into existing workflows without batch processing. Results of the new Access SARS-CoV-2 IgG II test are delivered quickly on Beckman Coulter's award-winning immunoassay analyzers, including the DxI 800 high-throughput analyzer, which is capable of processing 200 samples per hour. For more information on Beckman Coulter's full suite of testing solutions or its commitment to the fight against COVID-19, visit www.BeckmanCoulter.com/Coronavirus .

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.

References
¹ The result will be displayed as non-reactive (/=10AU/mL).
² At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.
³ All data are based on the Access SARS-CoV-2 IgG II Assay Instructions for Use (C69152)

© 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.

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SOURCE Beckman Coulter Diagnostics