Faster Flu Test Wins FDA Approval

A new test to quickly and effectively distinguish between seasonal, H1N1, and other types of flu promises to improve pandemic preparedness.

Flu symptoms are easy to spot, but figuring out which strain of influenza is at work is often a complex and time consuming task. A new tool promises to streamline the process, providing public health officials with a faster diagnosis to help governments respond quickly and efficiently to the threat of a pandemic.

Developed by the Centers for Disease Control and Prevention (CDC), the diagnostic kit uses a novel modular design, incorporating multiple tests that were previously performed separately. Combining them saves time and money, according to CDC’s Influenza Division director, Nancy Cox, PhD.

“This will lead to more efficient testing, with cost savings for the federal government and for state and local public health agencies,” said Dr. Cox, who is also Director of the World Health Organization Collaborating Center for Surveillance, Epidemiology and Control of Influenza.

The kit uses specimens taken from the upper or lower respiratory tracts. The first module determines whether the virus is influenza type A or B. The second module classifies the virus by its subtype, such as H1N1, H3N2, or 2009 H1N1. The final module detects the highly pathogenic H5N1 avian flu. CDC plans to distribute the kit globally to qualified public health laboratories.

Frequent testing is a key element of pandemic preparedness—a lesson US officials learned during the rapid spread of the H1N1 virus in 2009. A thorough review of that incident “showed a clear need for better diagnostic tests,” said Nicole Lurie, MD, MPH, assistant secretary for preparedness and response in the US Department of Health and Human Services.

“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,” Dr. Lurie said.