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

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



Beckman Coulter logo. (PRNewsfoto/Beckman Coulter)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/beckman-coulters-sars-cov-2-igg-ii-antibody-test-receives-emergency-use-authorization-from-the-fda-301254200.html

SOURCE Beckman Coulter Diagnostics

News Provided by PR Newswire via QuoteMedia

The Conversation (0)

Medtronic announces cash dividend for third quarter of fiscal year 2025

The board of directors of Medtronic plc (NYSE: MDT) on Thursday, December 5, 2024, approved the company's cash dividend for the third quarter of fiscal year 2025 of $0 .70 per ordinary share. This quarterly declaration is consistent with the dividend increase announcement made by the company in May 2024. Medtronic is a constituent of the S&P 500 Dividend Aristocrats index, having increased its annual dividend payment for the past 47 consecutive years. The dividend is payable on January 10, 2025 to shareholders of record at the close of business on December 27, 2024 .

About Medtronic
Bold thinking. Bolder actions. We are Medtronic . Medtronic plc , headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic , visit www.Medtronic.com and follow Medtronic on LinkedIn .

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Cardiex Limited (ASX:CDX)

Cardiex Limited


Keep reading...Show less

Global Medical Service Robotics Market Project to Exceed $20 Billion in 2024 with Additional Growth Expected

FN Media Group News Commentary - Innovations in robotics technology, including artificial intelligence machine learning, and sensor technology, are enhancing the capabilities of medical robots. These advancements enable more precise surgical procedures, improved rehabilitation processes, and efficient hospital logistics, thus attracting more healthcare facilities to adopt robotic solutions. The market is characterized by a moderate level of merger and acquisition (M&A) activity by the leading players. This is due to several factors, including the desire to expand the business to cater to the growing demand for medical service robots. A report from Grand View Research said that the global medical service robots market size was estimated at USD 20.59 billion in 2024 and is projected to grow at a CAGR of 16.5% from 2025 to 2030. It said: "The growth can be attributed to the introduction of technologically advanced robotic equipment in the healthcare sector and the rise in per capita healthcare spending. Continuous advancements in technology, such as robotic catheter control systems (CCS), data recorders, data analytics, remote navigation, motion sensors, 3D-Imaging, and HD surgical microscopic cameras, are projected to drive industry growth. Furthermore, the introduction of swarm robotics is opening new opportunities for industry. It is a new approach to coordinating multi-robotic systems through swarm intelligence." Active Tech Companies in the markets today include Jeffs' Brands Ltd (NASDAQ: JFBR), Serve Robotics Inc. (NASDAQ: SERV), Symbotic Inc. (NASDAQ: SYM), Microbot Medical Inc. (NASDAQ: MBOT), Medtronic plc (NYSE: MDT).

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Healing People and Planet: 3 Things You Need to Know About This Shared Innovation Challenge

By Ken Washington, Chief Technology and Innovation Officer, and Raman Venkatesh, Chief Sustainability Officer, Medtronic

When you think about healthcare technology, you may imagine the pacemaker assisting your dad's ailing heart, the sutures your child received after a bike accident, or the pulse oximeter placed on your finger during your annual physical exam. You probably don't think about the energy or resources required to manufacture those products, nor the resulting emissions and waste.

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Healing People and Planet: New Impact Report Outlines How Medtronic Is Shaping the Future of Health

Medtronic

Medtronic releases 2024 Impact Report highlighting success in healthcare equity with new data from the Healthy Neighbor program, in addition to community engagement and environmental sustainability progress

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×