Roche has begun to roll out its high-throughput antigen check for COVID-19 throughout Europe, with plans to ramp up manufacturing to “a double-digit million variety of exams monthly” to assist meet worldwide calls for by early subsequent yr.
The corporate acquired a CE Mark for the automated laboratory diagnostic it first introduced in mid-October, which is designed to alleviate among the burden on molecular-based exams which have served because the gold normal for detecting energetic coronavirus infections for the reason that starting of the pandemic.
The Elecsys antigen check makes use of deep nasopharyngeal or oropharyngeal swab samples collected by healthcare professionals, just like PCR diagnostics, and medical research have proven a 5.5% fee of false-negative outcomes and a false-positive fee of 0.1%, based on Roche.
“Healthcare programs stay beneath important stress to ship sturdy testing choices, with a adequate variety of exams out there,” Roche Diagnostics CEO Thomas Schinecker stated in a press release. “The launch of our high-throughput antigen check will present extra testing capability to reliably help healthcare programs in diagnosing SARS-CoV-2 an infection, as a complement to PCR testing.”
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The check runs on the corporate’s cobase immunochemistry analyzers, at as much as 300 exams per hour. The corporate has additionally filed the diagnostic for assessment with the FDA.
Roche beforehand launched an antigen check designed to ship particular person outcomes on the level of care inside 15 minutes. In September, it outlined plans to start delivery 40 million of these exams to Europe, earlier than rising manufacturing to about 80 million monthly by the top of this yr.
The newest lab-based model, in the meantime, completes the set of Roche’s several types of coronavirus exams and their respective use instances: the corporate now affords PCR, antibody and antigen exams out there for each high-throughput processing in a laboratory in addition to close to the affected person with speedy, point-of-care outcomes.
RELATED: Roche to produce antibody exams to Moderna’s COVID-19 vaccine trial
Earlier this month, Roche acquired an FDA authorization for a brand new, delicate antibody check able to measuring concentrations and gauging an individual’s potential immunity to the novel coronavirus. The corporate additionally introduced it might provide Moderna with the check, to assist measure the success of its vaccine.