Beckman Coulter Launches High-Throughput COVID-19 Antigen Test

Beckman Coulter 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 one of 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.

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 25 million tests per month, and the assay separates sample collection and processing, enabling test providers to leverage the existing infrastructure and workflows.

"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."

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.

Beckman Coulter is filing for Emergency Use Authorization (EUA) 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.