If you have a fever and a cough, you no longer necessarily need to go to the doctor to find out if it’s the flu or Covid-19 – at least in the United States, for now.
On Friday (24), the Food and Drug Administration (FDA), a US agency similar to Anvisa, authorized what it says is the first home test that can tell users if they have the flu and/or Covid-19. .
The test, made by Californian biotechnology company Lucira Health, uses a single self-collected nasal swab and can provide results in about half an hour. The test can be purchased without a prescription. It is authorized for anyone 14 years and older for self-collection, or an adult may use on a child 2 years and older.
The test is capable of identifying a negative result for influenza A with greater than 99% accuracy and a positive result with greater than 90% accuracy. It is 100% accurate for Covid-19 negative samples and over 88% accurate for positive results.
There weren’t enough cases of influenza B while Lucira was testing the product to measure that performance, so the company says it will have to do a real-world test when there are enough viruses in circulation. But in laboratory studies, it detected almost 100% of negative cases.
All tests carry a risk of false positive or false negative results. People who test positive for the flu or Covid-19 should take precautions not to spread the disease. Negative results must be confirmed with a laboratory test, the FDA said, “if necessary for patient management.”
Studies show that an at-home test can be less accurate than a lab test because users may not get enough of a sample for a valid result. Healthcare professionals can also access more sensitive tests.
People with flu-like or Covid-like symptoms but testing negative may have a different type of respiratory infection and should receive follow-up care.
Doctors have historically been reluctant to leave testing to their patients, but the Covid-19 pandemic has changed some of that sentiment. Studies have pointed out that people do not need medical training to test for respiratory diseases.
While the intensity of the pandemic has eased and cases are decreasing, the US still had 236,131 new cases, 2,407 deaths and an average of 3,461 hospitalizations this week, according to the Centers for Disease Control and Prevention (CDC). Seasonal flu activity is low nationally, says the CDC.
Testing for Covid-19 and the flu is helpful because both illnesses can be treated with different medications, and these medications work best when taken as soon as possible after symptoms start.
“Today’s authorization of the first OTC test that can detect Influenza A and B, along with SARS-CoV-2, is an important 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 on Friday.
Source: CNN Brasil
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