April 23, 2021

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‘More confidence about the results’: FDA authorizes two rapid COVID-19 tests for home screening

3 min read

Consumers will soon be able to buy rapid COVID-19 tests at chain pharmacies and grocers without a prescription after the Food and Drug Administration on Wednesday authorized two home tests. 

The BinaxNOW COVID-19 self-test will include two tests per kit for serial screening, with the no-prescription test delivering results in 15 minutes which does not require a lab. The FDA also authorized the Quidel QuickVue COVID test that delivers results in 10 minutes and can be used without a prescription. 

The FDA has authorized more than 300 COVID-19 tests and technologies in what’s becoming an increasingly crowded field of medical labs and tech firms touting different technologies.   

The federal agency authorized only two other no-prescription home tests, but companies that make those tests are ramping up production and are not yet available to purchase. Several more tests allow people to collect nasal or saliva samples at home, but people must send samples to a lab, delaying for one to two days. 

But by greenlighting the Abbott and Quidel tests that can be purchased by consumers without a prescription, the federal agency is significantly expanding access to testing for Americans. The authorization comes two weeks after the agency announced a streamlined path for serial testing to screen people without symptoms.

Abbott’s test should be administered twice over three days with 36 hours between tests. Quidel’s test should be used twice over three days with 24 to 36 hours between tests. 

“The benefit is it gives you more confidence about the results,” said Mary Rodgers, an Abbott principal scientist. “If you catch someone at the right time in their infection, testing more than once will give you more opportunities to find any positive results when someone is most infectious.” 

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Abbott’s home test is the same version widely used in nursing homes, schools and workplaces, and the company says the tests will soon be available for purchase at yet-to-be-named food, drug and mass merchandise retailers. The company has the manufacturing muscle to make and ship out 50 million rapid tests each month.

Abbott will sell the two-test kits to retailers for less than $20. Retailers will set prices, but Abbott officials said prices should be comparable or cheaper to other health tests sold directly to consumers.

Quidel said it will announce retail partnerships in the coming weeks and its test will soon be available for purchase. The company is building a new factory that will open later this year with a capacity to make more than 50 million QuickVue rapid antigen tests each month, according to a news release. 

Advocates of screening with inexpensive rapid antigen tests say the authorization of home tests is an important step to give consumers the option of testing themselves without visiting a doctor or telehealth provider — extra steps that take time and cost money. 

Michael Mina, an infectious disease epidemiologist at the Harvard T.H. Chan School of Public Health, said frequent testing can prevent Americans from unknowingly spreading the virus. He believes the frequent testing used in tandem with vaccination will limit the spread of COVID-19.

“Frequent rapid testing will be important in the months and years to come as we understand more about how long immunity lasts from the vaccine and how variants evolve,” he said.

Both the Abbott and Quidel tests can be used on children two years of age or older when adults handle the samples. Adults and most teens will be able to administer their own tests.

The Abbott kit comes with a nasal swab, reagent solution and a test card. Users administer the swab to their nose to obtain a sample and insert the swab in a test card. Similar to a pregnancy test, the card displays results within 15 minutes.

Ken Alltucker is on Twitter as @kalltucker or can be emailed at alltuck@usatoday.com


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