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Lenco diagnostic labs among the first to offer Beckman Coulter semi-quantitative antibody test
Beckman Coulter, a leader in clinical diagnostics, announced that its Access SARS-CoV-2 IgG II antibody test has received US Emergency Use Clearance (EUA) from the U.S. Food and Drug Administration. United States. The semi-quantitative test measures a patient’s antibody level in response to a previous infection with SARS-CoV-2 and provides a qualitative and numerical result of antibodies in arbitrary units (AU).
Lenco Diagnostic Laboratories, one of New York’s largest private full-service reference laboratories, is among the first to offer the test at its facilities in Brooklyn, New York and the tri-state metro area. Lenco has performed an independent verification of the test performance and is very satisfied with the quality of the results.
“To help fight COVID-19, it’s important that we partner with a company that has the reputation, quality and accuracy of testing like Beckman Coulter to meet the needs of New Yorkers,” said Robert Boorstein, MD, Ph.D., medical director, Lenco Diagnostics Laboratories. “This next step in testing for COVID-19 antibodies creates a pathway that helps us establish a quantitative basis for different levels of antibodies and determine how a patient’s immune response to COVID-19 is affected over time. We hope clinicians find this test useful in tracking a patient’s progress in recovery from COVID-19 and assessing the immune response over time.
The Access SARS-CoV-2 IgG II assay measures IgG antibodies directed against the receptor binding domain of the coronavirus spike protein. The test has a confirmed negative percent agreement of 100% (specificity) and a positive percent agreement of 98.9% (sensitivity) at> / = 15 days after symptom onset. The Access SARS-CoV-2 IgG II assay can be used in Random Access (RAM) mode and fits seamlessly into existing workflows without batch processing.
“High-quality, effective diagnostic solutions are essential in the fight against COVID-19,” said Shamiram R. Feinglass, MD, MPH, medical director of Beckman Coulter. “Antibody tests like our Access SARS-CoV-2 IgG II test can help researchers quantitatively determine IgG antibody levels and allow them to assess relative changes in an individual’s immune response to the SARS virus. -CoV-2 over time. This information is essential because it helps to continuously inform the development of therapies and vaccines. “
The Access SARS-CoV-2 IgG II Antibody Test is now available in the United States and in countries accepting the CE mark. New assay results are delivered on award-winning Beckman Coulter immunoassay analyzers, including the DxI 800 high-throughput analyzer, capable of processing up to 4,800 samples per day. The IgG II antibody test is the latest addition to Beckman Coulter’s comprehensive line of test solutions that provide 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 the FDA’s Emergency Use Authorization (EUA) Policy C. For more information on Beckman Coulter’s antibody assays, as well as its full line of COVID-19 diagnostic solutions, visit www.BeckmanCoulter.com/Coronavirus. For more information on Lenco Diagnostic Laboratories and its commitment to be part of the solution for COVID-19, visit: lencolab.com/covid19-antibody/.
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