Beckman Coulter announced the launch of its new Access SARS-CoV-2 Antigen assay, which can deliver results in as little as 30 minutes. In addition, Beckman Coulter has priced the test at $4 for all healthcare providers, including public and private institutions, governments and non-profits to enable frequent testing, according to a press release.
Beckman Coulter said it is filing for emergency use authorization for 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. The test will be made available to markets accepting the CE Mark in January 2021.
Unlike some other antigen tests to detect SARS-CoV-2, the Beckman Coulter assay is not a point-of-care test.The assay runs on the organization's immunoassay analyzers, including the DxI 800, a high-throughput analyzer capable of processing 200 samples per hour, enabling test providers to leverage the existing infrastructure and workflows.
The Access SARS-CoV-2 Antigen assay has proven 93 percent positive percent agreement (PPA) within seven days post-symptom onset and 100 percent negative percent agreement (NPA). The assay also has a limit of detection of 33 TCID50/mL, which is two 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, Beckman Coulter asserted.
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 being transported to the laboratory for processing.
