Dec. 18, 2020—Beckman Coulter launched the Access SARS-CoV-2 Antigen assay, a high-throughput COVID-19 test available in the U.S., priced at $4 to health care providers, including public and private institutions, governments, and nonprofits.
The assay has proven 93 percent positive percent agreement within seven days post-symptom onset and 100 percent negative percent agreement and has a limit of detection of 33 TCID50/mL. Test results are available in as little as 30 minutes on the company’s immunoassay analyzers, including the DxI 800, which can process 200 samples per hour. 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.
Beckman is filing for FDA emergency use authorization of the assay; it will be made available to markets accepting the CE mark in January. The company says it can deliver up to 25 million tests per month.