FDA Clears New Test for Identification of Influenza

A new test developed by the U.S. Centers for Disease Control and Prevention (CDC) to diagnose influenza infections and influenza A (H5N1) viruses has been cleared by The U.S. Food and Drug Administration (FDA). In addition, for diagnostics use with the test, the FDA also cleared a diagnostic system developed by Applied Biosystems, Incorporated, to be used to analyze the test material.

The device, known as the Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel), can the detect virus and differentiate between seasonal and novel influenza by utilizing a molecular biology technique. In secretions taken from a person’s nose or throat, the device isolates and magnifies any viral genetic material. This material is then marked with fluorescent molecules and detected and analyzed by the diagnostic instrument called the Applied Biosystems 7500 Fast Dx. Both products received the FDA 510(k) clearance independently. However, they are required to be used together as a system for the detection of influenza.

The new test panel, together with the diagnostics system, can test numerous samples at once and provide results in about four hours, identifying circulating human influenza viruses and influenza A (H5N1) viruses. The use of the two-part system can help to standardize testing and sub-typing the flu virus while providing accuracy, specification and dependability of test results.
U.S. Department of Health and Human Service Secretary, Mike Leavitt said, “This is a significant achievement for public health surveillance.” He then added, “The test allows us to better support laboratories on the front line of influenza testing in the United States and abroad.”

Regarding the possibility of a pandemic, Leavitt explained, “The application of the test to detect an emergent influenza virus would be especially important in the early stages of a pandemic. This breakthrough allows for a more timely detection of a pandemic virus, which helps in determining when to begin broad control strategies as well as life-saving mitigation measures, such as closing schools, canceling social gatherings and informing businesses to begin work-at-home policies.”

Mark Stevenson, president and chief operating officer for Applied Biosystems stated, "In this instance, we've been able to apply our real-time PCR technology to support laboratories on the front line of influenza testing in the United States. This is an important diagnostic tool that will enhance monitoring of influenza infections each year and improve early detection of influenza viruses with pandemic potential in the United States and abroad."

The CDC, Applied Biosystems, and the Association of Public Health Laboratories worked together to develop the test. State public health laboratories in Virginia, Iowa, California, Massachusetts, Wisconsin, and Washington performed clinical evaluations of the flu panel. The test will be available for diagnosing influenza this fall to CDC-qualified laboratories, with some laboratories having the ability to obtain substances used in the testing, known as reagents, at no cost.