FDA Approves Rapid At-Home COVID Test

Tens of millions of tests are expected to be available next month. 

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 Wednesday amid a coronavirus testing shortage as cases of the Omicron variant surge across the country. Siemens Healthineers said it expects to provide “tens of millions” of tests each month beginning in January. 

“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 is reported to have an 86.5 percent accuracy in detecting positive cases and 99 percent accuracy in detecting negative cases, compared to the PCR test. 

As the Lord Leads, Pray with Us…

  • For all officials in the FDA as evaluate and issue authorizations on medication and tests.
  • For protection and healing for those who are exposed to COVID-19.
  • For the president and executive branch as they continue to work to address the ongoing pandemic.

Sources: Washington Examiner, CBS News 


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