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New Applied Biosystems test diagnoses flu fast
WASHINGTON (Reuters) - A fast new genetic flu test from Applied Biosystems Inc and the U.S. Centers for Disease Control and Prevention won approval from the U.S. Food and Drug Administration on Tuesday.
The test, designed to quickly detect both bird flu and seasonal influenza strains, should be rolled out to state health departments soon, the company and the CDC said.
"We are now better prepared to more rapidly detect seasonal and pandemic influenza strains," the CDC's Dr. Dan Jernigan said in a telephone interview.
The test amplifies genetic material from the virus so it can be measured, to quickly identify the specific strain of flu that is infecting someone.
Telling a dangerous new strain of flu apart from the ordinary seasonal kind is key to identifying a pandemic, Jernigan said.
"The importance early in a pandemic is detection of the pandemic strains when they first emerge in a community," he said.
The new test is designed to be used by specialized labs such as those at state health departments, and not in doctors' offices.
Flu season is just beginning in the northern hemisphere. Most experts agree that a pandemic of a new and dangerous flu strain has to come some time, but no one can say when or where. The chief suspect now is the H5N1 avian influenza strain mostly affecting birds.
According to the World Health Organization, H5N1 has infected 387 people in 15 countries and killed 245 of them. The fear is that it will mutate just enough to allow it to pass easily from person to person.
If it does so, it could cause a catastrophic pandemic, killing tens of millions of people.
The new test can tell health officials if people are infected with garden variety flu or a new strain. People are occasionally infected with flu from pigs or birds, usually without serious effects, but there is no real system in place for keeping tabs on this, Jernigan said.
The new test will help CDC do that.
"It will also help us to find these things that we don't even know what it is yet," he said.
"Developed through a coordinated effort between the CDC and Applied Biosystems, the new test can accurately detect and identify commonly circulating human influenza viruses as well as avian influenza A (H5N1, Asian lineage) viruses within four hours and in multiple samples at one time," the company said.
(Editing by Cynthia Osterman)
