The U.S. Food and Drug Administration has cleared for marketing a test that simultaneously detects four common respiratory viruses, including the flu, in a patient's respiratory secretions.
The ProFlu+ test provides results in as few as three hours. Other diagnostic tests for respiratory viruses are fast but not as accurate or are accurate but not as rapid.
The real-time test employs a multiplex platform that allows several tests to be processed using the same sample to detect influenza A virus, influenza B virus, and respiratory syncytial virus A and B (RSV).
These viruses can cause influenza, an infection of the airways called bronchiolitis, and pneumonia. All are among the leading causes of lower respiratory tract infections.
“Antiviral drugs are most effective when initiated within the first two days of symptoms,” said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. “This new test, which is part of the new era of molecular medicine, can help the medical community quickly determine whether a respiratory illness is caused by one of these four viruses and initiate the appropriate treatment.”
ProFlu+ uses a molecular biology process to isolate and amplify viral genetic material present in secretions taken from the back of the throat in patients.