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Bird flu test receives federal approval

The new test can provide results on suspected H5 influenza samples within four hours. That process used to take two to three days.

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.
FDA approves faster test for bird flu in humans
03 Feb 2006 18:35:39 GMT
Source: Reuters
 (Adds test and lab details, agency statement, background)

NEW YORK, Feb 3 (Reuters) - U.S. regulators have approved a new, faster test for diagnosing strains of bird flu in humans suspected of being infected with the virus, the U.S. Department of Health and Human Services said on Friday.

The test designed to detect strains of Asian H5 flu provides preliminary results on suspected samples within four hours, instead of at least two to three days with current testing technology, the agency said.

The H5N1 subtype of H5 flu virus has killed 86 people in Asia and Turkey, and is the strain doctors and scientists fear could cause a worldwide flu pandemic should it begin to easily be transmitted from human to human.

More than half of the people known to have been infected by the H5N1 strain of bird flu have died. However, nearly all of the cases are believed to have been caused by exposure to infected poultry.

The new test, which was developed by the Centers for Disease Control and Prevention (CDC), is called the Influenza A/H5 (Asian lineage) Virus Real-time RT-PCR Primer and Probe Set.

"This laboratory test is a major step forward in our ability to more quickly detect cases of H5 avian influenza and provides additional safeguards to protect public health," HHS Secretary Mike Leavitt said in a statement.

"The availability of this new test gives us one more tool to keep up with the ever changing nature of influenza viruses," he said, praising the CDC and the U.S. Food and Drug Administration, which approved the test.

The new test will be distributed to a network of some 140 labs in all 50 U.S. states designated to enhance early detection and surveillance activities as well as to increase laboratory response capacity, the agency said.