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The clearance for the BD FACSDuet Sample Preparation System enables it to be integrated with the BD FACSLyric Flow Cytometer.
The RT-PCR-based test, which runs on Becton Dickinson's BD Max system, simultaneously detects SARS-CoV-2, influenza A and B, and respiratory syncytial virus.
The test, which received Emergency Use Authorization from the US Food and Drug Administration in July, runs on the BD Veritor Plus Analyzer System.
The supplement adds a collection vial to the BD Onclarity test and includes performance data for the BD Viper LT and the BD COR Systems.
The Seattle-based firm believes its novel collection devices are convenient and safe enough to use at home to draw blood for many types of tests.
Federal mandates requiring frequent SARS-CoV-2 testing for nursing home employees and significant purchases of rapid antigen tests from HHS have raised concerns about capacity.
Comparing the BD and Quidel rapid antigen tests showed they performed similarly despite sensitivity differences in initial FDA filings.
The new report said that point-of-care testing could rise to 70 million tests per month, or more, by October based on manufacturers' announced market entry plans.
Healthcare providers need multiplexed tests that can differentiate the flu from the coronavirus so they can treat patients quickly and appropriately.
In using the act, the HHS applied priority-rated orders for SARS-CoV-2 diagnostic supply contracts with Becton Dickinson and Quidel through September.