The Access SARS-CoV-2 Antigen assay is offered to healthcare providers at $4, making reliable and frequent mass testing affordable
Assay’s limit of detection is 2 to 200 times lower therefore more sensitive than most point-of-care (POC) antigen tests
Test runs on Beckman Coulter’s analyzers capable of processing up to 200 samples per hour, enabling high throughput screening in just 30 minutes and addressing the scalability constraints of POC tests
Company is submitting for EUA and can ship up to 25 million tests per month
BREA, CALIF., DEC. 18, 2020 —Beckman Coulter, a leader in clinical diagnostics, today 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 tests1. 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 lives2. New York University economist Paul Romer suggested recently that number could be significantly higher3. 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.