MONDAY, JUNE 18, 2018

FDA approves new influenza diagnostic kit

The U.S. Food and Drug Administration has authorized the use of a laboratory diagnostic kit to diagnose human infections with seasonal influenza viruses and novel influenza A viruses with pandemic potential.
The Centers for Disease Control and Prevention developed the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, which will be given at no cost to qualified international public health laboratories in an effort to improve global laboratory capacity for detecting influenza virus infections in human respiratory tract specimens.
“As the spread of the H1N1 pandemic slowed last year, we conducted an end–to–end review of our nation’s medical countermeasure enterprise, which showed a clear need for better diagnostic tests,” Dr. Nicole Lurie, the assistant secretary for preparedness and response in the U.S. Department of Health and Human Services, said. “In helping public health officials quickly identify seasonal flu as well as the flu viruses that could become pandemic, this kit can make a real difference in protecting health and saving lives in the United States and around the world.”
The in-vitro kit uses a three-module design. The first module identifies and distinguishes between infection with influenza A and B viruses, the second further classifies influenza A virus by subtype and the last module specifically detects highly pathogenic avian influenza A. The modular design makes the kit more efficient for use by diagnostic laboratories and eliminates waste by allowing users the ability to order components separately.
"This will lead to more efficient testing, with cost savings for the federal government and for state and local public health agencies,” Nancy Cox, the director of the CDC's Influenza Division and the director of the World Health Organization Collaborating Center for Surveillance, Epidemiology and Control of Influenza, said.
While upper respiratory specimens are easily obtainable in an outpatient or inpatient setting, the test kit is the only IVD for influenza that is FDA cleared for use with lower respiratory tract specimens. Studies have shown that testing for lower respiratory tract specimens can help detect influenza virus infections that can be overlooked by testing solely upper respiratory tract samples.