Beckman Coulter plans $4, high-volume COVID-19 antigen check

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Beckman Coulter plans to launch a $Four coronavirus antigen check designed for mass screening, with the purpose of delivery as much as 25 million per 30 days by March.

The Entry antigen assay is designed for high-throughput laboratory {hardware} and may ship particular person leads to 30 minutes whereas processing as much as 200 samples per hour. The corporate stated it’s presently submitting the check to the FDA for emergency overview.

As well as, the $Four price ticket holds for all healthcare suppliers—in addition to private and non-private establishments resembling faculties, companies, authorities companies and nonprofit organizations—to assist encourage repeated COVID-19 screenings.

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“To check the plenty and check them often, we’d like an reasonably priced, dependable and scalable answer,” stated Beckman Coulter’s chief medical officer, Shamiram Feinglass.

As well as, Beckman Coulter stated its lab-based check will be extra delicate and simpler for screening giant volumes of individuals in comparison with the speedy, hand-held antigen exams that will must be run separately.

“A degree-of-care check that delivers a lead to 15 minutes for a single particular person can’t carry out as effectively when it’s requested to ship outcomes for bigger populations; the workflow breaks down with too many handbook steps within the course of,” Feinglass stated. “Moreover, a hospital should report constructive outcomes to regulatory our bodies, and lots of [point-of-care] exams require cumbersome handbook recording of affected person information into their [electronic medical record].”

RELATED: With FDA nod, Beckman Coulter plans to ship 30M antibody exams per 30 days

Nevertheless, the trade-off consists of probably delayed outcomes as a result of time wanted to ship samples to a centralized testing laboratory for evaluation. Beckman Coulter stated its nasopharyngeal swabs will be saved at room temperature for 24 hours and refrigerated for 48 hours throughout transport.

The antigen assay has been proven to agree with constructive outcomes from molecular-based PCR exams 93% of the time and with detrimental outcomes 100% of the time when used inside seven days of the primary signs.

Following authorization from the FDA, the corporate stated it could instantly start delivery 18 million exams month-to-month within the U.S.; Beckman Coulter additionally plans to make the check obtainable in Europe beneath a CE mark in January.

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