Medical Device

Beckman Coulter, a clinical diagnostics leader, today announced their commitment to support the U.S. government's plan to invest more than $12 billion to expand COVID-19 testing with their high-throughput, high-quality lab antigen test, Access SARS-CoV-2 Ag,* ideal for mass screening testing.


Beckman Coulter announced in December that their $4 antigen test will be available to all customers and has a confirmed 93% positive predictive agreement (PPA) and 100% negative predictive agreement (NPA). Results can be delivered in as little as 30 minutes on Beckman Coulter's immunoassay analyzers, including the DxI 800 high-throughput analyzer that can process up to 200 samples every 60 minutes.

"We support the U.S. government's goal to expand screening because this is the right way to open up our schools, our economy and get people back to work in tandem with the massive vaccination drive that is underway," said Julie Sawyer Montgomery , president of Beckman Coulter Diagnostics. "The key to saving lives while vaccines are being put into arms is still masking, social distancing, regular testing, tracing and isolation. Our antigen assay makes the regular testing part of this equation a reality by enabling institutions and communities to implement low-cost, frequent, mass COVID-19 testing with automation, ease of handling and speed to enable scalability."

Beckman Coulter's antigen test can be used for testing in high-risk settings, such as nursing homes, hospitals, universities and other group settings where repeat testing, coupled with relevant clinical information, could identify those with a SARS-CoV-2 infection to minimize transmission i .

"We are offering our solution at $4 per test because it's only with affordable and regular testing that we can address disparities and promote equity in COVID-19 testing, which is vital to address COVID-19-related health gaps and advance health equity among high-risk and underserved populations, including racial and ethnic minority groups and people living in rural areas," said Shamiram R. Feinglass , M.D., MPH, chief medical officer for Beckman Coulter.

While point of care (POC) antigen tests have a purpose in diagnosing COVID-19, they are difficult and resource intensive to scale to address high-volume testing needs ii . Only Beckman Coulter's $4 SARS-CoV-2 antigen test makes large-scale, serial testing programs feasible and affordable.

"A point of care test that delivers a result in 15 minutes for a single individual cannot perform as efficiently when it's asked to deliver results for hundreds or thousands of people; the workflow breaks down with too many manual handling steps in the process," said Dr. Feinglass. "Furthermore, a hospital is compelled to report positive results to the regulatory bodies, and some point of care tests require cumbersome manual recording of patient data into their EMR."

Ideal for implementing as part of a large-scale community, workplace or school screening program, Access SARS CoV-2 Antigen test samples are collected with a nasopharyngeal or nasal swab and can be stored at room temperature for up to 24 hours and 48 hours refrigerated (2-8 degrees Celsius) with one freeze/thaw cycle.

The assay also provides ultimate flexibility in scaling to address the needs of small or low volume to moderately-sized laboratories that operate a desktop analyzer, to large laboratories with automated, high-throughput analyzers for mass testing. Whether on a desktop with an Access 2 or on a high-throughput analyzer like the DxI 800, results are immediately delivered electronically to physicians, patient portals and health agencies, allowing clinicians to initiate proper treatment quickly, isolate patients, and start tracing, helping to minimize the spread of COVID-19.

Learn more about Beckman Coulter's affordable, reliable and designed for high-throughput antigen solution at wwwbeckmancoulter.com/accessantigen .

Beckman Coulter's Suite of COVID-19 Testing Solutions

Beckman Coulter offers a menu that matters for COVID-19, including the $4 Access SAR-CoV-2 Antigen assay, as well as three antibody assays: Access SARS-CoV-2 IgM, Access SARS CoV-2 IgG and the semi-quantitative SARS-CoV-2 IgG II. Beckman Coulter is also developing a SARS-CoV-2 quantitative IgG assay based on WHO reference ranges.

The company also has an interleukin 6 (IL-6) assay, which can be used to aid physicians in identifying a severe inflammatory response and determining the risk of intubation with mechanical ventilation in COVID-19 patients. Beckman Coulter also offers a biomarker that measures monocyte distribution width (MDW), which can be used as an aid in the early detection of sepsis in adult patients presenting to the emergency department. Earlier this year, the company received government funding to develop a machine learning algorithm to help accurately predict and detect sepsis in COVID-19 patients leveraging its MDW test. Additionally, in mid-October, Beckman Coulter was awarded funding by for a multi-center clinical trial to validate the ability of MDW to aid in the rapid detection of Multisystem Inflammatory Syndrome in Children (MIS-C), a severe COVID-19 complication.

All of Beckman Coulter's assay to address COVID-19 can be performed in automated or high-throughput immunoassay formats, as well as with Beckman Coulter's Access 2 analyzer, a compact, tabletop 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.

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.

i https://www.reuters.com/article/health-coronavirus-rapid-tests/countries-turn-to-rapid-antigen-tests-to-contain-second-wave-of-covid-idUSL8N2H44VF [Accessed: October 19, 2020 ]
ii
https://www.the-scientist.com/news-opinion/the-push-to-deploy-at-home-antigen-tests-for-covid-19-67831 [Accessed: October 12, 2020 ]

*This test has not been reviewed by the FDA. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high complexity tests.

For Use Under the Emergency Use Authorization (EUA) Only. For In Vitro Diagnostic Use. Access IL-6 is available in the U.S. under the FDA Emergency Use Authorization program as an aid in identifying COVID-19 patients at risk of intubation with mechanical ventilation.

© 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. 2021-8839

Beckman Coulter logo. (PRNewsfoto/Beckman Coulter)

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SOURCE Beckman Coulter Diagnostics

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