Flu Test Expanded By FDA As 43 States Hit By High Influenza Cases

The U.S. Food and Drug Administration has given the go-signal for the expanded use of a flu test in doctors' offices, emergency rooms, health department clinics and other health care facilities.

The F.D.A. made the move as flu cases continue to rise in the United States, with the latest report showing that 43 states are experiencing either high or widespread flu activity, mostly resulting from circulation of drifted H3N2 viruses.

The Alere i Influenza A & B test, a nucleic acid-based test, has been granted waiver by the F.D.A. under its Clinical Laboratory Improvement Amendments (C.L.I.A.).

With this, the F.D.A. now "allows the first nucleic acid-based test to be available in clinical settings that previously could not use this technology," said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the F.D.A.'s Center for Devices and Radiological Health.

He said tests such as the Alere i will now "allow health care professionals to receive test results more quickly to inform further diagnostic and treatment decisions."

The F.D.A. said the Alere i Influenza A & B test uses a nasal swab sample from a patient with flu signs and symptoms.

The test results can be obtained in just 15 minutes and may be performed in the presence of the patient, the F.D.A. said. However, negative results do not rule out influenza virus infection.

Influenza, or flu, the F.D.A. said, "is a contagious respiratory illness caused by two types of influenza viruses: Type A and Type B."

More than 200,000 people in the U.S. are hospitalized due to seasonal flu-related complications every year, according to the Centers for Disease Control and Prevention.

The C.D.C. has recommended flu vaccination because it can prevent infection and serious flu-related complications.

It said vaccination and immediate treatment should be done especially for high-risk individuals including those who are at least 65, children younger than five years old, pregnant women and those people with health conditions such as heart disease, asthma and chronic lung disease.

Last June the F.D.A first cleared Alere i Influenza A & B test as a prescription device.

It granted the waiver under C.L.I.A. for the test after its manufacturer submitted data that showed the test's ease of use and low risk of false results.

It said the test showed high accuracy in identifying patients with or without influenza A and influenza B by users untrained in laboratory procedures.