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

Rhea-AI Summary

Beckman Coulter announced that its Access SARS-CoV-2 IgG II antibody assay has received U.S. Emergency Use Authorization (EUA) from the FDA. This semi-quantitative test measures antibody levels post-SARS-CoV-2 infection, delivering results that will help clinicians monitor patients' immune responses. The assay boasts a 99.9% specificity and 98.9% sensitivity. Available in the U.S. and countries accepting the CE Mark, it integrates into existing workflows and can process up to 4,800 samples per day using the DxI 800 analyzer. Beckman Coulter aims to enhance COVID-19 diagnostics.

Positive

• Access SARS-CoV-2 IgG II antibody assay received U.S. Emergency Use Authorization.
• The assay shows 99.9% specificity and 98.9% sensitivity at 15-60 days post-symptom onset.
• The test integrates with existing workflows and supports high-throughput processing of 4,800 samples per day.

Negative

• None.

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).

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 99.9% negative percent agreement (specificity) and a 98.9% positive percent agreement (sensitivity) at 15-60 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.

References:

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

© 2021 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.
2021-8737

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SOURCE Beckman Coulter Diagnostics

FAQ

What is the Access SARS-CoV-2 IgG II antibody assay?

The Access SARS-CoV-2 IgG II antibody assay is a semi-quantitative test that measures antibody levels in response to a previous SARS-CoV-2 infection.

When did Beckman Coulter receive EUA for its antibody test?

Beckman Coulter received Emergency Use Authorization for the assay on March 23, 2021.

What are the sensitivity and specificity of the IgG II antibody assay?

The assay has a specificity of 99.9% and a sensitivity of 98.9% within 15-60 days post-symptom onset.

What is the processing capability of the DxI 800 analyzer?

The DxI 800 analyzer can process up to 4,800 samples per day.

Where is the Access SARS-CoV-2 IgG II antibody assay available?

The assay is available in the U.S. and in countries accepting the CE Mark.