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Author: Robin Robinson, Ph.D., Director, Biomedical Advanced Research and Development Authority

Like they do each flu season, during the 2009 H1N1 pandemic healthcare providers sent samples to a lab and waited days to learn whether their patients were sick from the new H1N1 virus or another type of flu virus. The results could change the treatment the doctor prescribed. Today we have fast, easy and reliable flu diagnostic tests which can be used closer to patients in the emergency department. But we don’t know yet what impact these tests really have on clinical decision-making. How does using these near-patient tests affect what treatments doctors prescribe for emergency patients who are at increased risk for flu complications? How can the test results be pulled together in almost real time and health departments alerted to help clinicians control the spread and impact of flu in their communities?

To help answer these questions and more, Johns Hopkins will research the impact of rapid, near-the-patient flu diagnostic tests during the next three years under a new $4.4 million cooperative agreement funded by BARDA. This study marks the first cooperative agreement partnership BARDA has with a non-government partner. We’re excited about the opportunity and coordinating with CDC and public health partners.

Specifically the University’s School of Medicine in Baltimore, Md., will assess the performance of rapid, near-patient tests and evaluate the impact of influenza testing on the decisions doctors make in prescribing antivirals for emergency patients. Johns Hopkins researchers will also develop, validate and implement an electronic clinical decision guide for patients’ symptoms and signs of flu; this guide can assist healthcare providers with influenza testing decisions for their emergency department patients who are at increased risk of complications from the influenza. The research also will demonstrate the feasibility of using an electronic, cloud-based, data aggregation system to consolidate and structure influenza test results in real-time.

The researchers also will look at whether a system like this helps communicate results within facilities and across public health networks more easily than current systems. To do this, they’ll be working with Cepheid, an influenza diagnostic test manufacturer.

Johns Hopkins will coordinate the clinical research in four emergency departments over two influenza seasons. Collaborating in the study are Olive View-UCLA Medical Center in Sylmar, Calif.; Maricopa Integrated Health System in Phoenix, Ariz.; Truman Medical Center in Kansas City, Mo., and Bayview Medical Center in Baltimore, Md. All four of these emergency departments are part of the EMERGEncy ID Net, a network of high-volume, geographically diverse and academically affiliated emergency departments. The network was first formed in 1995 through collaboration and support by CDC.

Emergency departments provide critical information about seasonal and pandemic influenza preparedness and response. Each year, emergency departments evaluate and treat almost 10 million patients with influenza-related illnesses, and more than 200,000 of these patients require hospitalization. Findings from this multi-site, multi-year research will be published to provide an evidence base for clinicians, healthcare facilities and public health officials so they can make important decisions about implementing new rapid influenza tests in near-patient settings, such as emergency departments.

We’re making big strides in developing better flu diagnostic tests and effective antiviral medications and vaccines to protect against influenza and its potentially deadly complications. We know that our healthcare system has to respond to pandemics and other public health emergencies with the systems that are in place at the time. With the research we’re funding through Johns Hopkins, we can make a difference in the systems that are in place, and how ready our nation is for the next public health emergency. And the more prepared we are across the country for pandemic flu, the better we can respond day-to-day to seasonal flu outbreaks. It’s all about saving lives and protecting health in an emergency and every day.

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This is archived ASPR content.