Beckman Coulter's SARS-CoV-2 IgG II antibody test receives Emergency Use Authorization from the FDA

- Lenco Diagnostic Laboratories among first to offer Beckman Coulter's semi-quantitative antibody test; Lab expects clinicians will use assay to monitor patients' COVID-19 recovery and assess immune response over time[1]

- Assay available to ship in the U.S. and countries accepting the CE Mark

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Beckman Coulter Diagnostics

Mar 23, 2021, 16:15 ET

BREA, Calif., March 23, 2021 /PRNewswire/ -- Beckman Coulter, a clinical diagnostics leader, today announced that its Access SARS-CoV-2 IgG II antibody assay received U.S. Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration. The semi-quantitative assay measures a patient's level of antibodies in response to a previous SARS-CoV-2 infection and provides a qualitative and numerical result of antibodies in arbitrary units (AU).

Serology testing is a way that we look to make sure that individuals are mounting an immune response. What you see when we're looking for an immune response are immunoglobulins rising. When someone gets infected, say with #coronavirus they have an infection called, #COVID-19. With #serology, we measure what those levels of antibodies are in your body.

To identify who has an immune response against the #coronavirus. It’s important to detect an antibody called Immunoglobulin G or #IgG. IgG antibodies are proteins produced seven to fourteen days after an infection by the immune system in response to an infection and are specific to that particular pathogen.

In this video, Beckman Coulter's Chief Medical Officer, Dr. Shami Feinglass, discusses the importance of antibody test quality, and the differences between the types of antibody tests on the marker.

Lenco Diagnostic Laboratories, one of New York City's largest privately-owned, full-service reference labs, is among the first to offer the test in its facilities across Brooklyn, NYC, and the tri-state metropolitan area. Lenco conducted an independent verification of the assay's performance and is highly satisfied with the quality of the results.

"To help in the fight against COVID-19, it is important that we partner with a company that has the reputation, quality, and testing accuracy like Beckman Coulter in meeting the needs of the people of New York," said Robert Boorstein, M.D., Ph.D., medical director, Lenco Diagnostics Laboratories. "This next step in COVID-19 antibody testing creates a pathway in helping us establish a quantitative baseline of different antibody levels and determine how a patient's immune response to COVID-19 is affected over time. We expect that clinicians will find this assay useful for monitoring the progress of a patient's COVID-19 recovery and assessing the immune response over time."

The Access SARS-CoV-2 IgG II assay measures IgG antibodies directed to the receptor-binding domain of the spike protein of the coronavirus. The test has a confirmed 100% negative percent agreement (specificity) and a 98.9% positive percent agreement (sensitivity) at >/= 15 days post symptom onset. The Access SARS-CoV-2 IgG II assay can be used in Random Access Mode (RAM) and seamlessly integrates into existing workflows without batch processing.

"Effective and high-quality diagnostic solutions are essential in the fight against COVID-19," said Shamiram R. Feinglass, MD, M.P.H, chief medical officer at Beckman Coulter. "Antibody assays like our Access SARS-CoV-2 IgG II test can help researchers quantitatively determine the levels of IgG antibodies and enable them to assess the relative changes of an individual's immune response to the SARS-CoV-2 virus over time. This information is essential because it helps continually inform therapeutics and vaccine development."

The Access SARS-CoV-2 IgG II antibody assay is now available in the U.S. and countries accepting the CE Mark. Results of the new test are delivered on Beckman Coulter's award-winning immunoassay analyzers, including the DxI 800 high-throughput analyzer, capable of processing up to 4,800 samples per day.

The IgG II antibody assay is the latest addition to Beckman Coulter's full suite of testing solutions that provide clinicians valuable information in their fight against COVID-19. Beckman Coulter also recently launched an automated SARS-CoV-2 antigen test in the U.S. under Policy C of the FDA's emergency use authorization (EUA) program. For more information on Beckman Coulter's antibody assays, as well as its full suite of COVID-19 diagnostic solutions, visit www.BeckmanCoulter.com/Coronavirus.

For more information about Lenco Diagnostic Laboratories, and its commitment to being part of the solution for COVID-19, visit: https://www.lencolab.com/covid19-antibody/.

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.

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¹ At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.

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