FDA approves expansion of the scope of influenza rapid detection products

The U.S. flu season has so far killed 21 people, and in an effort to combat the flu, the U.S. Food and Drug Administration has approved the expansion of the use of a molecular test product that quickly detects influenza viruses with a swab in the nose.
testing products manufactured by Alere and are now widely used clinically, including doctors' offices, emergency rooms, clinics and other medical facilities. Previously, the product could only be used a limited number of times in the laboratory.
the U.S. Food and Drug Administration first approved Alere's I influenza A-B testing product in June as a prescription device, which is classified as medium complex and therefore not widely used.
FDA said that based on data submitted by the company, untrained operators are more susceptible to use and have a low risk of false positive results, so the agency agreed to a wider application of the product.
today's decision allows nucleic acid testing products to be used clinically for the first time and cannot be used before," said Gutierrez, director of the FDA's Office of In-body Diagnostics and Radiological Health. "
nucleic acid test is to detect the genetic material of the virus. Alere's test products take only 15 minutes to get results and can be performed in front of patients.
influenza is caused by two types of viruses: type A and type B. Infections range from mild to severe. According to the Centers for Disease Control and Prevention, more than 200,000 people are hospitalized or have flu-related complications in the United States each year.
Alere rose 1.4 percent to $37.25 on the New York Stock Exchange. (Lilac Garden)