New York: The first combination test for flu and COVID-19 has been approved by the US Food and Drug Administration (FDA).
The test can be done at home, allowing people to conveniently determine if a runny nose is caused by flu or COVID-19, PTI reported.
The Lucira COVID-19 & Flu Home test can be purchased across the counter without a prescription, and uses self-collected nasal swab samples. The result is delivered in about 30 minutes, FDA said.
COVID self-use test kits were developed early during the pandemic and are readily available for the last two years. This is the first home test for influenza A and B, commonly known as flu.
With FDA granting the test emergency use authorization, it will be available during public health emergencies.
“It’s a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home,” said Jeff Shuren, director of FDA’s Center for Devices and Radiological Health.
The test can be used by people with “signs and symptoms consistent with a respiratory tract infection”. It can be used on children as young as 2 years old, with adults collecting the samples, FDA informed.
There is, however, a risk of false positive and negative results, cautioned FDA.
“Individuals who test negative and continue to experience symptoms of fever, cough and-or shortness of breath may still have a respiratory infection and should seek follow-up care with their healthcare provider,” the agency said.
However, considering the impact of COVID and another respiratory infection RSV, the FDA said it “recognises the benefits that home testing can provide” and will increase the number of tests available.
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