Molecular Diagnostic Panel Approved for Influenza

A human influenza virus real-time polymerase chain reaction (RT- PCR) Diagnostic Panel has been approved as a laboratory test kit.

The kit was developed by the US Centers for Disease Control and Prevention (CDC; Atlanta, GA, USA) and it uses a three-module design that streamlines two of the CDC's previously approved diagnostic tests.

The kit is designed to diagnose human infections with seasonal influenza viruses and human infections with novel influenza A viruses that have pandemic potential. The first module is used to identify and distinguish between infection with influenza A and B viruses; the second module further classifies influenza A viruses by subtype (H1N1, H3N2, or 2009 H1N1); and the third module specifically detects highly pathogenic avian influenza A (H5N1), commonly known as "bird flu." The kit is also the only in vitro diagnostic test for influenza to be cleared for use with lower respiratory tract specimens, thereby facilitating disease detection in critically ill patients such as those requiring mechanical ventilation. Each component can be ordered separately, according to the laboratory's needs.

Nancy Cox, PhD, director of the CDC's Influenza Division said, "This will lead to more efficient testing, with cost savings for the federal government and for state and local public health agencies." The diagnostic panel has been approved by the US Food and Drug Administration (FDA; Silver Springs, MD, USA). Nicole Lurie, MD, assistant secretary for preparedness and response in the US Department of Health and Human Services (Washington DC, USA) stated that, "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." Accordingly, the CDC test kit will be given at no cost to qualified international public health laboratories.

Related Links:
US Centers for Disease Control and Prevention
US Food and Drug Administration
US Department of Health and Human Services