Beckman Coulter SARS-CoV-2 IgM Antibody Test Receives FDA Emergency Use Authorization

Beckman Coulter, a clinical diagnostics leader, today announced its Access SARS-CoV-2 Immunoglobulin M (IgM) assay has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The assay detects antibodies that recognize the receptor binding domain (RBD) of the spike protein which the SARS-CoV-2 virus uses to enter the human host cells. The assay, which demonstrates 99.9% specificity and 98.3% sensitivity, is part of a suite of diagnostic solutions being developed by Beckman Coulter in response to the ongoing COVID-19 pandemic to guide physicians and patients in their healthcare decision making.


Beckman Coulter's Access SARS-CoV-2 IgM antibody assay receives Emergency Use Authorization from the U.S. FDA

"Since March, the Beckman Coulter team has worked around the clock to develop a suite of assays that play a critical role in the ongoing global fight against COVID-19," said Julie Sawyer Montgomery , president of Beckman Coulter. "As a science-driven company, we continue in our commitment to deliver rigorously validated diagnostics of the highest quality that provide meaningful information, so doctors and patients alike can trust the results for urgent, care decisions."

Beckman Coulter's suite of COVID-19 testing solutions includes the Access SARS-CoV-2 IgM assay and the Access SARS CoV-2 IgG assay, which received EUA in June. The company also recently received FDA Emergency Use Authorization for its interleukin 6 (IL-6) assay, which can be used to assist in identifying severe inflammatory response in patients with confirmed COVID 19 illness to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing. Beckman Coulter is also currently developing a SARS CoV-2 antigen assay as well as a quantitative IgG assay anticipated to be launched later this year.

All of the Beckman Coulter assays to address COVID-19 can be performed in automated or high-throughput immunoassay formats, as well as Beckman Coulter's Access 2 analyzer, a compact, table-top analyzer enabling high-quality serology testing to be carried out in small hospitals and clinics. Additionally, all of the assays seamlessly integrate into laboratory workflows making it easy to add these tests to routine blood tests performed during inpatient and wellness testing.

For more information on Beckman Coulter's suite of testing solutions or its commitment to the fight against COVID-19, visit: www.BeckmanCoulter.com/Coronavirus .

About the Access SARS-CoV-2 IgM Assay

The Access SARS-CoV-2 IgM Assay is a qualitative immunoassay that detects IgM antibodies. The test has confirmed 98.3% positive percent agreement (sensitivity) at 15-30 days post symptom onset and 99.9% negative percent agreement (specificity). The assay utilizes an immunocapture format to bind patient IgM antibodies on the magnetic particle solid phase and a recombinant SARS-CoV-2 protein - enzyme conjugate to detect anti-SARS-CoV-2 IgM. The Access SARS-CoV-2 IgM assay can be used in Random Access Mode (RAM), which means that the antibody tests can be run along with other immunoassay tests. The assay can also be used with a variety of Beckman Coulter analyzers, including the high-throughput DxI 800 designed for large labs, to the DxI 600 for mid-sized labs and the DxC 600i and Access 2 analyzers for smaller labs and healthcare clinics.

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, Calif. , and has more than 11,000 global associates working diligently to make the world a healthier place.

© 2020 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.

Beckman Coulter today announced its Access SARS-CoV-2 Immunoglobulin M (IgM) assay has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The assay detects antibodies that recognize the receptor-binding domain (RBD) of the spike protein which the SARS-CoV-2 virus uses to enter the human host cells.

Beckman Coulter logo. (PRNewsfoto/Beckman Coulter)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/beckman-coulter-sars-cov-2-igm-antibody-test-receives-fda-emergency-use-authorization-301149222.html

SOURCE Beckman Coulter Diagnostics

News Provided by PR Newswire via QuoteMedia

The Conversation (0)
Illustration of heart attack.

Investing in Cardiovascular MedTech Companies

Cardiovascular diseases remain the leading global cause of death, taking an estimated 17.9 million lives annually, based on data from the World Health Organisation. Over 80 percent of these deaths are due to heart attacks and strokes, while one-third of them occur in people under seventy years of age.

Efforts to address the core risk factors associated with cardiovascular diseases are coinciding with recent innovations in medical technology, which have been critical in not only preventing and managing them but also increasing the survival rate.

As medical technologies associated with the diagnosis and treatment of cardiovascular disease continue to evolve, medical technology companies provide an opportunity for investors to create wealth through health.

Keep reading...Show less

Thermo Fisher Scientific Reports First Quarter 2024 Results

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today reported its financial results for the first quarter ended March 30, 2024.

First Quarter 2024 Highlights

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
March Quarterly Appendix 4C

March Quarterly Appendix 4C

Cardiex Limited (ASX:CDX) (Cardiex, the Company) has released its Quarterly Cash Flow Report.


Keep reading...Show less
Cardiex March 2024 Quarter Update

Cardiex March 2024 Quarter Update

Cardiex Limited (ASX:CDX) (Cardiex, the Company) is pleased to present its Quarterly Report.
Keep reading...Show less

Medtronic: Americans Favor Quality Over Quantity in Pursuit of Longevity

According to a new survey from Medtronic and Morning Consult, nearly two-thirds of U.S. adults say they'd opt for a shorter, healthier life than a longer one with health issues

Americans overwhelmingly say that when they think about longevity, it's more than just living longer - it's about living their healthiest, best lives. While most want to live to 90-well past the average U.S. life expectancy of 77.5 years-nearly two-thirds (66%) would choose a shorter, healthier life over a longer one with health issues. These findings, from a survey conducted by global healthcare technology leader Medtronic with Morning Consult, highlight a gap between U.S. adults' desire to live healthier years and the opportunity for more people to improve their quality of life through healthcare technology

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×