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FDA authorizes first COVID-19, flu combo test for use at home

Dr. Stephen M. Hahn said that the combination test is "a significant step toward FDA’s nationwide response to COVID-19."

WASHINGTON — The U.S. Food and Drug Administration on Saturday approved its first at-home COVID-19 and flu combination test.

The Quest Diagnostics RC COVID-19 +Flu RT-PCR test is available to anyone with a prescription showing coronavirus or influenza A or B symptoms. The sample can be collected at home by the patient and shipped directly to a Quest Diagnostics laboratory for analysis.

The illnesses have such similar early symptoms that people who get the flu may mistakenly think they have COVID-19, said Dr. Gregory Poland, an infectious disease specialist at Mayo Clinic. Only a test can tell the two apart.

The FDA Commissioner Dr. Stephen M. Hahn said that the combination test is "a significant step toward FDA’s nationwide response to COVID-19." He added that this will be able to help address the raging pandemic in the middle of a flu season.

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“With just one swab or sample, combination tests that are authorized for use with home-collected samples can be used to get answers to Americans faster, in the comfort and relative safety of their home, which allows patients to continue to quarantine while awaiting results," Hahn said.

The U.S. Centers for Disease Control and Prevention recommends the flu vaccine for everyone starting at 6 months old, and suggests getting it by the end of October.

For most people, the new coronavirus causes mild or moderate symptoms. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia and death.

The United States has more than 14 million confirmed cases of COVID-19, according to data from Johns Hopkins University.

As of Sunday, the U.S. had more than 281,000 deaths from the virus. Worldwide, there are more than 66 million confirmed cases with more than 1.5 million deaths.

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The Associated Press contributed to this report.