The 15-Minute Flu Test

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The 15-Minute Flu Test

FDA grants waiver for Alere i Influenza A & B test

By Aaron Severson
to Save

200,000 Americans each year require hospital care for seasonal flu complications. A newly available flu test promises to make it a little easier for clinicians to determine whether a patient actually has influenza or just flu-like symptoms.

No Lab Required

The nucleic acid-based Alere i Influenza A & B test uses a nasal swab and can produce results in just 15 minutes. False negatives are possible, but the test can help doctors diagnose influenza infection.

The test has actually been available since last June, but it was initially limited to prescription-only use in labs licensed to conduct moderate- or high-complexity tests. The new waiver opens the door for the test to be distributed to other settings such as emergency rooms, health department clinics and physicians’ offices.

The FDA says the waiver was prompted by manufacturer-submitted clinical data showing that the test can be administered relatively easily and highly accurately by providers without laboratory training.

The Way of the Future?

“We expect many other simple and accurate tests using nucleic acid-based technology to be developed in the near future,” says Alberto Gutierrez, Ph.D., director of the FDA’s Office of In Vitro Diagnostics and Radiological Health. “Once cleared by FDA, such tests can allow healthcare professionals to receive test results more quickly to inform further diagnostic and treatment decisions.” 

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