Physicians can now use a new, fast molecular flu test in their offices that previously had only been approved for use in specialized laboratories, the U.S. Food and Drug Administration (FDA) announced.
“Today’s decision allows the first nucleic acid-based test to be available in clinical settings that previously could not use this technology,” Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a news release. “We expect many other simple and accurate tests using nucleic acid-based technology to be developed in the near future. Once cleared by FDA, such tests can allow health care professionals to receive test results more quickly to inform further diagnostic and treatment decisions.”
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According to the FDA, the nucleic acid-based test uses a nasal swab sample from a patient with symptoms of flu infection. The test provides results in as little as 15 minutes and may be performed in the presence of the patient. Negative results do not rule out influenza virus infection; the test is intended to aid in diagnosis along with the evaluation of other risk factors.
Because the FDA granted a waiver for the test via the Clinical Laboratory Improvement Amendments (CLIA), the Alere test can be distributed to a broad variety of clinical settings, including physicians practices, emergency departments, health departments, and other healthcare facilities.
The move comes as the nation’s physicians battle one of the severest flu seasons in years, resulting in dozens of deaths so far and higher levels of cases in the majority of states. One concern among public health experts is that a more severe flu strain, known as H3N2, appears to be circulating this season that flu shots do not fully protect against.
Flu symptoms are caused by two types of influenza viruses: Type A and Type B.
Flu infections can range from mild to severe and can sometimes lead to hospitalization and death. According to the Centers for Disease Control and Prevention, more than 200,000 people in the United States are hospitalized from seasonal flu-related complications each year.
To correctly report vaccine counseling and administration, it is important to recognize what the codes do and do not includes.
The codes below are limited to immunization administration, meaning that purchased vaccine products must be separately reported.