Now you can test yourself for COVID at home without a prescription, FDA says
The U.S Food and Drug Administration granted an emergency use authorization Tuesday for the first at-home COVID-19 test that does not require a prescription from a health care provider.
This means people can visit their local drug store, purchase a test, swab their own nose at home and get their results in about 20 minutes, said FDA commissioner Stephen Hahn in a statement.
The “Ellume COVID-19 Home Test” connects to a smartphone application that not only teaches people how to perform the test, but also helps them interpret their results. Any one over 2 years old can use the test.
“Today’s authorization is a major milestone in diagnostic testing for COVID-19,” Hahn said in the statement. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.”
Last month, the FDA authorized the first prescription at-home COVID-19 test, McClatchy News previously reported. Now, there are more than 225 authorized diagnostic coronavirus tests, including 25 that could be done at home.
The newly authorized test is an antigen test, which differs from the molecular (PCR) test most commonly used to diagnose COVID-19.
By wiping a nasal swab across a paper strip coated with “reactive molecules,” the test can detect pieces of proteins that belong to the coronavirus, if present in the sample. This can tell if a person is currently infected with the virus.
The FDA said the test “correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms. In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples.”
However, the agency notes that the test may get it wrong sometimes because antigen exams are known to have a lower sensitivity rate than molecular tests.
Antigen tests are usually cheaper and return results faster, but they have a sensitivity that varies between 34% to 80%, according to the World Health Organization, meaning “half or more of COVID-19 infected patients might be missed by such tests.”
Results from these exams usually need to be confirmed with a molecular test, which are accurate about 95% or more of the time, the FDA says.
How well antigen tests work depends on when during one’s illness the test is administered, the concentration of the virus in the sample, the quality of the sample and the “precise” mixture of liquids used in the chemical analysis in the test kit, according to the WHO.
False-positive results with antigen tests are less common than false-negatives, the FDA said, but they can occur if the reactive molecules on the test strip also recognize those of other coronaviruses, like those that cause the common cold.
The agency advises those who get a positive result using the new Ellume exam to get another test to confirm their diagnosis. The same action applies to people who test negative but are experiencing coronavirus-like symptoms.
Ellume officials said they expect to produce more than 3 million tests in January 2021.
This story was originally published December 15, 2020 at 1:45 PM with the headline "Now you can test yourself for COVID at home without a prescription, FDA says."
