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

Beckman Coulter, a clinical diagnostics leader, has 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 patients’ 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: lencolab.com/covid19-antibody/.

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