- The Food and Drug Administration on Wednesday announced that it has authorized Abbott Labs' rapid Covid-19 test for at-home use, though doctors must prescribe the test for patients.
- It's the third test authorized in the U.S. "that can be used completely at home," Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement.
- Patients collect the sample with a nasal swab themselves and an app helps guide the testing process and provide results, Abbott said.
The test, which is an antigen test that delivers results in about 15 minutes, had previously been authorized for use by trained personnel only, but the new clearance will allow patients to test themselves at home with virtual assistance from a doctor. It's the third test authorized in the U.S. "that can be used completely at home," Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement.
To deliver the test, which is called BinaxNOW and costs $25 for at-home use, to people's homes and to supervise the collection and testing process, Abbott said it has partnered with telehealth provider eMed. Patients collect the sample with a nasal swab themselves and an app helps guide the testing process and provide results, Abbott said.
Everyone 15 years or older who are suspected of having Covid-19 by their health-care provider and is within the first seven days of symptom onset are eligible for the test, the FDA said. The test can also be used in people 4 years or older, though an adult needs to collect the sample, the agency said.
"FDA continues to authorize COVID-19 tests that will give more Americans access to greater testing flexibility and options," FDA Commissioner Dr. Stephen Hahn said in a statement. "The BinaxNOW COVID-19 Ag Home Test will have a significant manufacturing footprint with the potential to support testing for millions of people."
Abbott said it expects to deliver 30 million at-home tests in the first quarter of 2021, with another 90 million in the second quarter. The FDA noted that antigen tests are not as accurate as many molecular tests.
"As the pandemic has evolved, the need for rapid testing has only grown. Unfortunately, we're still hearing that many people can't access testing as quickly as they need it," Robert Ford, Abbott's president and CEO, said in a statement. "That's why Abbott is bringing our rapid BinaxNOW test and NAVICA platform into homes."
The FDA first authorized the test for use by trained personnel in August, touting it at the time as the first Covid-19 test that costs about $5 and delivers results in minutes on a testing card without lab equipment, similar to a pregnancy test. The U.S. quickly purchased 150 million of the tests for $750 million to expand testing capacity.
However, at-home use of the test will cost $25, more than the $5 it costs in medical settings, Abbott said Wednesday.
"FDA's authorization of the BinaxNOW card test for home use means we should have tens of millions of COVID-19 tests in the coming months that Americans can use without leaving their home," Health and Human Services Secretary Alex Azar said Wednesday in a statement.
The authorization comes after the FDA cleared Ellume's at-home Covid test on Tuesday. That product was authorized for use in anyone 2 years or older and does not require a prescription.