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, one of the leaders in clinical diagnostics, has announced the launch of a new test that addresses the three main barriers currently facing schools, businesses, hospitals and communities with the rollout of mass COVID-19 testing. The new Access SARS-CoV-2 Antigen assay is the first cost-effective high-quality, high-throughput COVID-19 test available in the U.S. with the volume, workflow and scalable flexibility needed to help fight the COVID-19 pandemic.

The Access SARS-CoV-2 Antigen assay has proven 93% Positive Percent Agreement (PPA) within seven days post symptom onset and 100% Negative Percent Agreement (NPA). Additionally, the assay and has a limit of detection of 33 TCID50/mL, which is 2 to 200 times lower and therefore more sensitive than the reported limits of detection for most of the available point-of-care (POC) antigen tests. Results of the Beckman Coulter antigen test can be delivered in as little as 30 minutes on the organizations’ immunoassay analyzers, including the DxI 800, a high-throughput analyzer capable of processing 200 samples per hour.

According to the Rockefeller Foundation, 4.3 million COVID-19 tests per day are recommended to help minimize infection spread and save lives. New York University economist Paul Romer suggested recently that number could be significantly higher. Currently, only about 1.8 million RT-PCR tests are performed daily in the U.S.

While several point of care (POC) antigen tests are now available to help increase testing beyond current levels, POC tests come with workflow challenges when scaled to large patient populations. Beckman Coulter’s SARS CoV-2 Antigen test is designed to address these challenges. The organization can deliver up to 25 million tests per month, and the assay separates sample collection and processing, enabling test providers to leverage the existing infrastructure and workflows.

Additionally, Beckman Coulter’s new assay is priced at $4 to all healthcare providers, including public and private institutions, governments, and non-profits to enable frequent testing.

“While vaccines are coming, it will take time before everyone is able to receive their shot,” said Shamiram R. Feinglass, M.D., M.P.H., chief medical officer for Beckman Coulter. “Until then, the only way to save lives is to mask, socially distance, test, trace and isolate. To test the masses and test them frequently, we need an affordable, reliable, and scalable solution. Beckman Coulter is making this happen with a high-quality $4 COVID-19 test, so institutions and communities can implement, frequent mass COVID-19 testing that is easy to scale.”

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 transmission. 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 needs.

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.

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