- The Food and Drug Administration (FDA) announced Tuesday the emergency approval of the first COVID-19 test that can be done fully at home.
- Lucira Health’s COVID-19 nasal swab self-test provides results in 30 minutes or less, and is authorized only on prescription.
- People over the age of 14 can take the test if their healthcare provider suspects they may have COVID-19, the FDA said.
- Stephen M. Hahn, FDA commissioner, said: “While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home.”
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The US Food and Drug Administration (FDA) on Tuesday approved the first at-home COVID-19 test kit for emergency use.
The COVID-19 All-In-One Test Kit, made by biotech company Lucira Health, is the first nasal swab test that can be fully self-administered at home, and it provides results in 30 minutes or less, according to a statement from the government agency.
Once the patient has done the nasal swab, it is then stirred into a vial and placed in a test unit. Within minutes, lights indicate whether the individual is positive, negative, or needs to repeat the test.
The single-use test has been approved for people over the age of 14 where their healthcare provider suspects they may have coronavirus, the FDA said. It was authorized for prescription use only.
The kit can also be used in hospitals, urgent care centers, and emergency rooms, but patients under 14 years should have their sample collected by a healthcare provider, the FDA said.
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Stephen M. Hahn, FDA commissioner, said in the statement: “While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home.
“This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.”
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The FDA didn’t say how much the test would cost, Lucira Health’s website says the test is “intended to cost less than $50.”
Business Insider has contacted Lucira for comment.
More than 11.4 million people in the US have been infected with coronavirus and more than 248,000 people have died from it, according to the New York Times’ COVID-19 tracker.
The US has more cases than any other country, and is currently being hit by a third wave of infections.