FDA Authorizes at-Home Test That Can Help Diagnose COVID, Influenza and RSV

Test samples still need to be sent to a lab, but the tests are the first to be available without a prescription that can be utilized within a patient's home

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One Chicago-area suburb has reached a “high” community COVID risk level, under guidelines set by the Centers for Disease Control and Prevention. At the same time, two additional counties have joined nearly the entire Chicago area in reaching an elevated risk level.

The Food and Drug Administration has authorized a first-of-its-kind at-home testing kit that will allow individuals to collect samples and have them tested for a variety of respiratory illnesses, including COVID-19 and influenza.

According to a press release issued Monday, the FDA gave authorization to Labcorp’s “Seasonal Respiratory Virus RT-PCR DTC” test.

Those tests, available without a prescription, can be used by individuals with symptoms of respiratory viral infection, according to the FDA.

The tests allow an individual to self-collect a nasal swab at home, similar to that of an at-home COVID-19 test. Instead of getting the results in the home, those samples can be sent to Labcorp for testing.

The tests can identify and differentiate between a variety of illnesses, including influenza A and B, respiratory syncytial virus (RSV) and COVID-19, according to the FDA.

“While the FDA has now authorized many COVID-19 tests without prescription, this is the first test authorized for the flu and RSV, along with COVID-19, where an individual can self-identify their need for a test, order it, collect their sample and send it to a lab for testing,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

The kits can be purchased online or in a store. Samples can be self-collected by individuals age 18 or older, or can be self-collected by individuals between the ages of 14 and 17 who are under adult supervision.

Children ages 2 and up can also use the kits, with adults performing the nasal swab to collect the sample.

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