United States Approves New Test To Identify Bird Flu in Humans

By Charlene Porter
Washington File Staff Writer

Washington – A new test to detect the H5 avian influenza virus in patients has been approved by the U.S. Food and Drug Administration (FDA), the agency announced February 3.

The new test will allow more rapid identification of the specific strain of avian influenza that emerged in East Asia, infecting hundreds of millions of birds and causing more than 160 human cases of disease so far.

Because of the H5N1 virus’ ability to cross the species barrier and the severe illness it causes in humans, international medical officials warn that it could set off a global influenza pandemic.

Developed by the U.S. Centers for Disease Control and Prevention (CDC), the new test will provide a preliminary result in hours, in contrast to previous testing methods that required two days to three days to produce a result from patient samples.

The influenza virus comes in dozens of types and subtypes. The H5N1 virus can be deadly, but the first symptoms it causes are frequently the same as those caused by common strains of annual flu.

This new test will help speed that first step in diagnosis and tell clinicians whether their patients are infected with a common illness or a lethal disease.

“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,” said Michael Leavitt, secretary of the Department of Health and Human Services, the department that oversees CDC and FDA.

“Thanks to the expeditious and collaborative efforts of CDC and FDA,” Leavitt said, “the availability of this new test gives us one more tool to keep up with the ever-changing nature of influenza viruses.”

After an initial diagnosis of the H5 strain, further testing is required to identify a particular subtype, such as H5N1. Faster identification of a virus will allow health authorities to respond more rapidly with control and prevention activities.

The full textof the announcement is available on the department’s Web site.


Iraq has become the seventh nation to report the fast-moving and severe respiratory disease that humans develop when infected with H5N1.

A 15-year-old Iraqi girl died of avian influenza, a United Kingdom laboratory has confirmed, verifying initial findings reported by the Iraqi Ministry of Health in late January.

According to a February 2 update issued by the World Health Organization (WHO), one other human death and three other human illnesses in Iraq also are being analyzed to determine if they were caused by the bird flu virus that appeared more than two years ago.

The outbreak of disease caused by this viral strain has been the broadest ever recorded, affecting animals in 13 nations and setting off alarms about the possibility of a global influenza pandemic among humans.

Such a pandemic could cause severe illness and death, and widespread social and economic disruption.

At the request of the Iraqi Ministry of Health, a team of international investigators is on the way to the area of northern Iraq where the disease has appeared.

Health officials have emergency operations in place to respond to more cases of disease should they appear, and to investigate rumors of disease. Officials are chasing down reports of additional cases, but so far none has been substantiated.

The human outbreak in Iraq is unusual because the illness was detected in people before reports of illness in birds. Typically bird illnesses and deaths mark the first appearance of the lethal virus in an area.

Early detection in the human population is a good thing, according to the WHO report, because it speaks to a high level of awareness about the disease.

Questions about whether human cases of H5N1 have been detected fully have cast a shadow over the accuracy of the count of human cases reported over the last two years.

Medical officials could not know whether people experienced milder cases of influenza but never visited a doctor or clinic; or, in rural areas of East Asia, perhaps people were dying of the flu because they had no access to medical care.


Turkish health officials are being applauded for their rapid detection, response and prevention when human cases appeared there for the first time in late December 2005 and January 2006.

"Turkey moved quickly to control the outbreak in people as soon as it appeared," said WHO Director-General Dr. Lee Jong-wook in Ankara, Turkey, February 2.

"Turkey reported cases quickly, worked fast on laboratory diagnosis, and informed the public about the risks,” he added. “As a result, the outbreak in humans was limited. Important lessons must now be applied from the Turkish experience."

Turkish officials were testing up to 100 patients a day during the height of the outbreak to determine if they were infected with H5N1.

Officials also were successful in reaching the public and warning them of the presence of disease. As a result, people with symptoms reported for tests.

The Turkish Ministry of Health identified 21 cases of H5N1 avian influenza. A WHO collaborating laboratory in the United Kingdom so far has confirmed 12 of those cases. Four human cases were fatal.

WHO information on bird flu is available on the agency’s Web site.

For additional information on the disease and efforts to combat it, see Bird Flu (Avian Influenza).