Automated Assay for Influenza and RSV Cleared

The US Food & Drug Administration (FDA) has cleared an on-demand automated molecular test for rapid, reliable determination of Flu A, Flu B, and differentiation of respiratory syncytial virus (RSV) infection. Redundant targets extend coverage for detection of seasonal and emerging new influenza strains.

The FDA-cleared Xpert Flu/RSV XC cartridge test from Cepheid (Sunnyvale, CA, USA) runs on GeneXpert System, Cepheid’s leading molecular diagnostic platform, with more than 7,500 systems installed worldwide.


Upper respiratory infections are one of the most common reasons for doctor and hospital visits and in the US are the most common illnesses leading to school or work absences. RSV is the most common cause of bronchiolitis and pneumonia among infants and children under 1 year of age. With Xpert Flu/RSV XC, hospitals and clinicians can be prepared to reliably diagnose and differentiate influenza strains and RSV in real-time. "Influenza strains are notoriously unpredictable and the severity of flu outbreaks can vary widely from season to season," said John Bishop, Cepheid's Chairman and CEO, "Recent media coverage of serious viruses such as Enterovirus D68 and Ebola have raised public awareness, and created a greater need for healthcare workers to deliver timely and accurate test results for flu or RSV infection."

Doctors Donna M. Wolk and Raquel M. Martinez, investigators at Geisinger Health System, were involved in investigational testing of Xpert Flu/RSV XC during Cepheid's product development phase. Their microbiology team is planning a pilot testing program called FluWorks, which aims to allow test results to be immediately delivered to physicians and patients or designated family members via electronic health records, web portal, or text-messaging.

"We are anxious to understand the role that the Xpert Flu/RSV XC test can play in Geisinger's FluWorks program, designed to improve patient care, clinical operations, and laboratory stewardship. Rigorous investigational testing documented the assay's high accuracy and speed," said Dr. Wolk, "This winter, we plan to leverage the test's unique design to quickly test patients presenting with influenza-like illness at emergency departments, out-patient clinics, and in selected urgent-care clinics."

"We employed a novel in silico approach to identify multiple complementary target segments to avoid the effects of seasonal genetic drift and to anticipate emerging novel influenza strains. Though simple to perform, Xpert Flu/RSV XC is a highly multiplexed, state-of-the-art test for fast and accurate detection and differentiation of Flu A, Flu B, and RSV infection," said David Persing, MD, PhD, Cepheid's Chief Medical and Technology Officer, "This test may also become a valuable asset in efforts toward pandemic preparedness, because it was designed from its inception to provide unprecedented coverage of both human and avian influenza strains."

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