WASHINGTON (AP) – A laboratory test that can give a preliminary diagnosis of bird flu in humans received expedited approval Friday from the government.
The new test can provide results on suspected H5 influenza samples within four hours.
If the test is positive for the H5 strain, further testing would still be needed to confirm and identify the specific subtype of the virus, including the H5N1 strain responsible for the deaths of 86 people since 2003.
The FDA approved the test, developed by the Centers for Disease Control and Prevention.
“Preparing for a possible flu pandemic is a top priority for our nation, and FDA acted quickly to evaluate and expedite CDC’s request for approval of this test,” acting FDA Commissioner Dr. Andrew von Eschenbach said.
Health officials fear the H5N1 strain will evolve into a virus that can be passed from human to human and lead to an influenza pandemic.
The test “may enable earlier detection of influenza cases caused by this specific virus and allow public health agencies to investigate sources of infection and more quickly respond with control and prevention activities,” said CDC Director Dr. Julie Gerberding.
The new test will be distributed to laboratories in all 50 states beginning next week, the CDC said. The agency plans to share the technology with health officials around the world, including the World Health Organization.
Bird flu began cropping up in poultry stocks across Asia in 2003. Since then, it has killed or forced the slaughter of an estimated 140 million birds.
Almost all of the human deaths due to the virus have been linked to contact with infected poultry.
Because of safety concerns associated with the virus, only 140 U.S. laboratories with proper controls in place will receive the tests, said Dr. Steve I. Gutman, director of the FDA’s Office of In Vitro Diagnostics Device Evaluation and Safety.
Eighty percent of the population lives within one hour of one of the labs, said Stephan S. Monroe, acting director of the CDC’s Division of Viral and Rickettsial Diseases.
The test is not intended for mass screening, officials said. The initial plan is to give it to people with respiratory symptoms who have traveled to areas where the flu is present, Gutman said.
The FDA took just two weeks to approve the test. Von Eschenbach said the speed did not compromise the “quality or integrity of the FDA review process.”
—
Associated Press writer Randolph E. Schmid contributed to this report.
—
On the Net:
Government bird flu information: http://www.pandemicflu.gov
AP-ES-02-03-06 1554EST
Send questions/comments to the editors.
Success. Please wait for the page to reload. If the page does not reload within 5 seconds, please refresh the page.
Enter your email and password to access comments.
Hi, to comment on stories you must . This profile is in addition to your subscription and website login.
Already have a commenting profile? .
Invalid username/password.
Please check your email to confirm and complete your registration.
Only subscribers are eligible to post comments. Please subscribe or login first for digital access. Here’s why.
Use the form below to reset your password. When you've submitted your account email, we will send an email with a reset code.