Lucira Health, which developed a dual-purpose diagnostic testing program, said it can produce a negative result in as little as 11 minutes and a negative result in about 30 minutes.
Lucira Health
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Lucira Health
Lucira Health, which developed a dual-purpose diagnostic testing program, said it can produce a negative result in as little as 11 minutes and a negative result in about 30 minutes.
Lucira Health
The Food and Drug Administration used emergency equipment on Friday for the first at-home test that can simultaneously detect both COVID-19 and the flu.
With a nasal swab, the single-use kit can provide results within 30 minutes, indicating whether a person is positive or negative for COVID, as well as influenza A and influenza B, which are two common strains of the virus.
People 14 and older can generally self-test, the FDA says. Those between the ages of 2 and 13 can happen with the help of adults.
Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, called the test “a milestone.”
“We must continue to take a greater approach to testing infectious diseases at home to support optimal public health,” Shuren said in a statement.
The test was developed by Lucira Health, a California-based company that was also the first to receive FDA approval for rapid home-based COVID tests in 2020.
According to the FDA, in human trials, the Lucira home kit accurately detected 88.3% of COVID infections and 90.1% of influenza A infections. The test can identify influenza B in lab studies, the FDA said. But because there aren’t enough cases of the virus circulating in real-world settings, further testing will be required, officials said.
The FDA also warned that, like all rapid diagnostic tests, there is a risk of false positives and false negative results. The agency says individuals who test positive for COVID or influenza should take appropriate precautions and follow up with a health care provider, while people who receive a negative result for either COVID or influenza B should confirm it with a preformed molecular test in a lab. .
Individuals who test negative but continue to experience symptoms of fever, cough or shortness of breath should also follow up with their health care provider in case of other respiratory viruses, the FDA said.
The dual-purpose test comes after a flurry of COVID-19, respiratory syncytial virus — or ARV — forced hospitals across the country last fall.
“The collective impact of COVID-19, the flu, and the flu have overtaken the importance of diagnostic tests for respiratory viruses,” the FDA said in a statement.
In the past few weeks, COVID-related deaths and hospitalizations have begun to decline, according to the most recent data from the Centers for Disease Control and Prevention. Similarly, the CDC found that rates of flu and RSV-related hospitalizations are decreasing.
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