The Food and Drug Administration has granted emergency use authorization to a new at-home rapid COVID-19 test manufactured by Siemens Healthineers.
The German-American company's at-home test was approved by the agency Wednesday amid a coronavirus testing shortage as cases surge across the country. Siemens Healthineers said it expects to provide "tens of millions" of tests each month beginning in January.
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“Undetected COVID-19 exposure is a major driver of community spread. With the CLINITEST Rapid COVID-19 Antigen Self-Test, consumers will have access to a fast, reliable, and convenient test to provide additional safety,” said Christoph Pedain, head of point of care diagnostics, in a statement. “Siemens Healthineers is proud to bring this high-quality test, already used and trusted by families, medical professionals, businesses and governments in many parts of the world, to the United States under FDA emergency use authorization.”
The test is a self-administered nasal swab with results in 15 minutes. It has an 86.5% accuracy in detecting positive cases and 99% accuracy in detecting negative cases compared to the PCR test.
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A test developed by Roche was approved last week. The Biden administration announced earlier this month it would distribute 500 million at-home tests free of charge.
The number of coronavirus cases has surpassed the highest number on record, with 265,000 new cases on average per day.