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Faster genetic test for flu virus approved
2008-09-30
ATLANTA - The government approved a new genetic test for the flu virus Tuesday that will allow labs across the country to identify flu strains within four hours instead of four days. The timesaving test could be crucial if a deadly new strain emerges, federal health officials said. The new test also could help doctors make better treatment decisions during a conventional flu season. The new test was developed by the Centers for Disease Control and Prevention and Applied Biosystems Inc. of Foster City, Calif. The Food and Drug Administration approved the test kit Tuesday, and state health labs are expected to start using it this fall. CDC officials celebrated it as a potential lifesaver, especially if the nation is hit by a pandemic of bird flu or some other mutant influenza. "We'll now be able to detect influenza in the community faster, which allows us to take steps more quickly to protect and save lives," CDC director Dr. Julie Gerberding said in a prepared statement. The CDC is requiring labs to buy Applied Biosystems equipment to run the test, and the CDC will provide the necessary chemicals. About 20 to 30 state labs should be up and running by the end of the year, CDC officials said. Until now, the tests used by different states varied. "Now we have all the states able to do this rapid method," said Pete Shult, who oversees infectious disease testing at Wisconsin's state laboratory. "It's good to use the same method so the results will translate from state to state, and CDC can better understand what's happening," he added. Six state labs evaluated the new test and found it to be as good as the "gold standard" traditional viral culture method, said Shult, who was involved in that review. The test correctly detected the most common flu viruses about 99 percent of the time. It also picked up some viruses that the older test missed. Shult and others said the new method's main selling point is its potential against a dangerous new pandemic. "The bottom line, for us, is that it will allow us to more rapidly detect introduction of a new strain," said Rosemary Humes, senior adviser for scientific affairs at the Association of Public Health Laboratories. But the test could be handy for conventional flu, too, said Dr. Doug Lowery-North, an Emory University emergency physician who does flu research. Doctors usually don't have the luxury of waiting three or four days for lab tests before deciding how to treat a flu-stricken patient. But getting a faster, better reading on the type of flu might help in prescribing the best medication, Lowery-North said. Each year, the flu results in 200,000 hospitalizations and 36,000 deaths, according to official estimates. The elderly, young children and people with chronic illnesses are considered at greatest risk. Health officials have been concerned not only about conventional forms of flu that circulate each year, but new varieties in Asia. They fear the current bird flu virus that has spread among Asian poultry and has killed some people could mutate into a deadly form that is easily spread among humans, potentially triggering a global pandemic.
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