Beckman Coulter Launches one of the First High-Quality, High-Throughput COVID-19 Antigen Test Ideal for Mass Testing in the U.S.

Beckman Coulter’s new antigen test is appropriate for many of the same populations as RT-PCR tests—individuals who are suspected of COVID-19 infection by their healthcare providers for various reasons, including known exposure or working in high-risk environments. According to the CDC, antigen tests can be used in high-risk settings, such as nursing homes, hospitals, universities and other group settings where repeat testing, coupled with relevant clinical information could identify COVID-19 infection to minimize transmission⁴. In addition, the FDA recently stated that it is now allowing antigen and molecular diagnostic tests to be used off-label in testing asymptomatic patients, as directed by a prescriber for prescription-use tests.

The Beckman Coulter antigen test can be a reliable alternative for laboratories to manage test demand and decrease their testing turnaround times. Moreover, while POC antigen tests have a purpose in diagnosing COVID-19, they are difficult and resource intensive to address high-volume testing needs⁵.

Dr. Feinglass added, “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 larger populations; the workflow breaks down with too many manual steps in the process. Furthermore, a hospital must report positive results to regulatory bodies, and many POC tests require cumbersome manual recording of patient data into their EMR.”

In contrast to the cumbersome workflow of POC antigen tests, the Beckman Coulter antigen test samples are collected with a nasopharyngeal swab at the point of care and can be stored at room temperature for up to 24 hours and refrigerated for 48 hours while transporting to the laboratory for processing. The ability to separate the sample collection from sample processing allows for flexibility to meet the needs of all Beckman Coulter customers from small laboratories that operate a desktop analyzer, to large laboratories that implement automated, high-throughput analyzers for mass testing.

Whether on a desktop or high-throughput analyzer, results are delivered electronically to physicians, patient portals and health agencies, allowing clinicians to initiate proper treatment, isolate patients, and start contact tracing, helping to minimize the spread of COVID-19.

Nicholas Decker, MLS (ASCP) laboratory director at Memorial Healthcare, “RT-PCR is a great tool; however, it is not one-size fits all. Affordable antigen testing is battle tested and has the ability to turn a laboratory into a well-rounded partner for our providers and patients.”

Beckman Coulter is filing for Emergency Use Authorization of the assay with the U.S. Food and Drug Administration (FDA) and can immediately begin shipping 18 million tests per month, and ramp to 25 million tests per month by March 2021 to its customer base throughout the U.S. and Puerto Rico under Policy C. The test will be made available to markets accepting the CE Mark in January 2021.

To learn more about the $4 Access SARS-CoV-2 Antigen assay including how to place an order, or for the latest information on Beckman Coulter’s response to COVID-19, visit www.beckmancoulter.com/antigenassay.