US Regulators Clear New Rapid COVID-19 Test Amid Widespread Shortages

By Zachary Stieber
Zachary Stieber
Zachary Stieber
Reporter
Zachary Stieber covers U.S. news and stories relating to the COVID-19 pandemic. He is based in Maryland.
December 30, 2021 Updated: December 30, 2021

The Food and Drug Administration (FDA) this week authorized a new, quick at-home COVID-19 test produced by Siemens Healthineers, as Americans grapple with a widespread shortage of testing options amid a record spike in COVID-19 cases.

The rapid antigen test is meant for individuals 14 or older to self-collect specimens. It can be used for younger persons if adults collect samples.

Results come back in just 15 minutes, according to the company, and it’s 86.5 percent accurate in detecting positive cases.

“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,” Christoph Pedain, head of point of care diagnostics for Siemens, said in a statement.

Lines at testing sites across the nation have swelled in recent weeks as the Omicron variant of the CCP (Chinese Communist Party) virus became dominant. The variant evades antibodies from both prior infection and vaccines better than the Delta variant, though protection against hospitalization holds up well, early studies show.

People have found it difficult in some areas to find at-home tests, and those ordered online aren’t being shipped until mid-January. Amazon even limited orders because of the jump in demand, as did CVS, Walgreens, and Walmart.

The Biden administration hopes the clearance of the Siemens test and another one from SD Biosensor that it just authorized will help ease the test shortages.

“Increasing Americans’ access to easy-to-use, reliable COVID tests is a top priority for the Biden Administration, and we are using all resources at our disposal to make more tests available and ramp up supply,” Health Secretary Xavier Becerra said in a statement. “Adding two new authorized tests will give Americans more options for testing at home, which helps keep people safe and provides peace of mind.”

The Department of Health and Human Services, which includes the FDA, in October announced it was utilizing $70 million from a congressional package to help bring more at-home tests onto the market.

The effort includes specialists from key agencies working together to analyze tests, speeding the authorization process.

President Joe Biden also last week announced the government would purchase 500 million at-home tests that would then be provided to Americans at no charge. The shipment of those tests is expected to start next month.

Zachary Stieber
Zachary Stieber covers U.S. news and stories relating to the COVID-19 pandemic. He is based in Maryland.