Swine flu test authorized for troops overseas

(AP) – 3 hours ago

WASHINGTON — The Food and Drug Administration said Tuesday it has authorized the emergency use of a swine flu test for U.S. troops overseas, allowing the military to speed up diagnoses and treatment of a virus that could cause widespread infections again this fall.

The FDA emergency authorization lets the Defense Department distribute the swine flu test to its qualified laboratories that have the right equipment and personnel to perform and interpret test results.

The authorization allows for the use of unapproved medical products or unapproved uses of approved medical products during a public health emergency, the FDA said.

The FDA said the test will help to speed up diagnosis of H1N1 infections so that deployed troops can quickly begin treatment.

The announcement comes as the government is gearing up for the arrival of a vaccine. First supplies are likely by October but most not until the Thanksgiving season.

Since swine flu was declared to be a pandemic, or global outbreak, by the World Health Organization in June, and it is expected to make a strong return in the fall and winter. The WHO has said the virus has killed nearly 1,800 people worldwide.

A presidential advisory panel said in a report presented Monday that a "plausible scenario" for the United States later this year is large-scale swine flu infections, possibly with 30,000 to 90,000 deaths, mostly among young children and young adults, and perhaps as many as 300,000 sick enough to require intensive care unit treatment at hospitals.

Seasonal flu typically causes 30,000-40,000 annual deaths, mainly among people over 65.
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FDA NEWS RELEASE

For Immediate Release: Aug. 25, 2009

Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Authorizes Emergency Use of H1N1 Test for U.S. Troops Serving Overseas

The U.S. Food and Drug Administration today announced it has issued an Emergency Use Authorization (EUA) that allows a 2009 H1N1 influenza virus test to be used to detect the virus in troops serving overseas.

The EUA allows the U.S. Department of Defense to distribute the H1N1 test to its qualified laboratories that have the required equipment and trained personnel to perform the test and interpret its results. An EUA authorizes the use of unapproved medical products or unapproved uses of approved medical products during a declared public health emergency.

“The FDA worked quickly with the Defense Department to authorize the use of this test to better protect our troops. The test will aid in more rapid diagnosis of 2009 H1N1 influenza infections so that deployed troops can quickly begin appropriate medical treatment,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D.

The U.S. Centers for Disease Control and Prevention (CDC) developed the test, which is called the CDC swH1N1 (swine) Influenza Real-Time RT-PCR.

Under this new EUA, the Defense Department’s Joint Biological Agent Identification and Diagnostic System (JBAIDS) can be used to run the CDC’s test. The FDA previously cleared other assays for use on the JBAIDS beginning in 2005.

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