Beckman Coulter SARS-CoV-2 IgG II antibody test received EUA

Lenco Diagnostic Laboratories was among the first to offer a semi-quantitative Beckman Coulter antibody test

Beckman Coulter, head of clinical diagnostics, announced that his test for Access SARS-CoV-2 IgG II antibodies received US approval for emergency use (EUA) from the US Food and Drug Administration. A semiquantitative test measures a patient’s antibody level in response to a previous SARS-CoV-2 infection and gives a qualitative and numerical result of the antibody in arbitrary units (AU).

Lenco Diagnostic Laboratories, one of the largest privately owned private services laboratories with full service, was among the first to offer testing at its facilities across Brooklyn, New York State and the three-state metropolitan area. Lenco conducted an independent test performance check and is very satisfied with the quality of the results.

“To help fight COVID-19, it’s important to team up with a company that has a reputation, quality and precision testing like Beckman Coulter to meet the needs of New Yorkers,” said Dr. Robert Boorstein, MD, Medical Director, Lenco Diagnostics Laboratories. “The next step in testing antibodies to COVID-19 creates a pathway that helps us establish a quantitative baseline of different antibody levels and determine how it affects a patient’s immune response to COVID-19 over time. We expect clinicians to find this test useful for monitoring the progress of a patient’s recovery from COVID-19 and assessing the immune response over time. “

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

“Effective and high-quality diagnostic solutions are key in the fight against COVID-19,” said Shamiram R. Feinglass, Ph.D. Med., Medical Officer, Chief Medical Officer at Beckman Coulter. “Antibody analyzes such as our Access SARS-CoV-2 IgG II test can help researchers quantify IgG antibody levels and allow them to assess the relative changes in an individual’s immune response to the SARS-CoV-2 virus over time. This information is crucial because it helps to continuously inform about the therapy and development of vaccines. “

The Access SARS-CoV-2 IgG II antibody test is now available in the United States and countries that accept the CE mark. The new test results are delivered on award-winning Beckman Coulter immunoassay analyzers, including a DxI 800 high-pass analyzer, capable of processing up to 4,800 samples per day. IgG II antibody analysis is the latest addition to Beckman Coulter’s complete suite of testing solutions that provides clinicians with valuable information in their fight against COVID-19. Beckman Coulter also recently launched an automated SARS-CoV-2 antigen test in the United States under policy C of the FDA’s Emergency Authorization Program (EUA). For more information on Beckman Coulter antibody tests, as well as the complete COVID-19 diagnostic package, visit www.BeckmanCoulter.com/Coronavirus. For more information about Lenco Diagnostic Laboratories and its commitment to being part of the COVID-19 solution, visit: lencolab.com/covid19-antibody/.

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