Furthermore, a hospital must report positive results to regulatory bodies, and many POC tests require cumbersome manual recording of patient data into their EMR.” 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. Moreover, while POC antigen tests have a purpose in diagnosing COVID-19, they are difficult and resource intensive to address high-volume testing needs.ĭr. The Beckman Coulter antigen test can be a reliable alternative for laboratories to manage test demand and decrease their testing turnaround times. 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. 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. 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.”īeckman 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. To test the masses and test them frequently, we need an affordable, reliable and scalable solution. “Until then, the only way to save lives is to mask, socially distance, test, trace and isolate. Feinglass, M.D., M.P.H., chief medical officer for Beckman Coulter. “While vaccines are coming, it will take time before everyone is able to receive their shot,” said Shamiram R.
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.Īdditionally, 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. Beckman Coulter’s SARS CoV-2 Antigen test is designed to address these challenges. 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. Currently, only about 1.8 million RT-PCR tests are performed daily in the U.S. New York University economist Paul Romer suggested recently that number could be significantly higher. 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.Īccording to the Rockefeller Foundation, 4.3 million COVID-19 tests per day are recommended to help minimize infection spread and save lives. 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.
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). with the volume, workflow and scalable flexibility needed to help fight the COVID-19 pandemic.īeckman Coulter’s assay is offered to healthcare providers at $4, making reliable and frequent mass testing affordable 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. Beckman Coulter, a leader 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.