On February 24, the Food & Drug Administration (FDA) authorized what the agency says is the fist at-home test for detecting both COVID-19 and the flu.
The test uses one nasal swab to collect a sample from the nose and generates results in roughly 30 minutes. It can be purchased without a prescription and is authorized for use in anyone over 14 years-old, or in children two to 14 with the help of an adult. It is made by Lucira Health, a biotech company based in California’s Bay Area.
“Today’s authorization of the first OTC test that can detect Influenza A and B, along with SARS-CoV-2, is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement. “The FDA strongly supports innovation in test development, and we are eager to continue advancing greater access to at-home infectious disease testing to best support public health needs. We remain committed to working with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them.”
According to the FDA, The Lucira COVID-19 and Flu Home Test can recognize positive results for influenza A with more than 90 percent accuracy and negative results with over 99 percent accuracy. For influenza B, there were not enough cases for a clinical study while Lucira was testing the product. However, in lab tests, it was 99.9 percent accurate in detecting negative results.
With COVID-19, it is 99.9 percent accurate for a negative result and more than 88 percent accurate with a positive result.
“As with all rapid diagnostic tests, there is a risk of false positive and false negative results. Individuals who test positive for either flu or COVID-19 should take appropriate precautions to avoid spreading the virus and should seek follow-up care with their physician or healthcare provider as additional testing may be necessary,” the FDA wrote.
The COVID-19 pandemic has changed some doctor’s hesitations regarding testing being performed by patients. A 2020 study found that people do not require medical training to test themselves for respiratory illnesses like COVID-19 and the flu.
Wilbur Lam, a pediatric hematologist and bioengineer at Emory University who helped federal officials with test development and validation, told The New York Times that this new test is the first in a series of tests that was taken for multiple illnesses at once.
“Now we’re in this new era that’s honestly pretty exciting,” said Lam. “It’s exciting for a health care provider, it’s exciting for the technology developers, and I think exciting for the public because we have this new test. And this is only the beginning.”
According to the US Centers for Disease Control and Prevention, the US saw 236,131 new cases, 2,407 deaths, and an average of 3,461 hospitalizations last week. After getting off to an explosive and early start, flu activity is low around the country.