FDA Approves 40-Minute Bird Flu Test

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Main Category: Bird Flu / Avian Flu
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 09 Apr 2009 - 11:00 PDT

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The US Food and Drug Administration (FDA) announced on Tuesday this week that it had cleared for marketing a new, faster test for detecting bird flu (influenza type A/H5N1) in humans that only takes 40 minutes to identify a marker protein that confirms the presence of the virus subtype from a swab.

The test, called AVantage A/H5N1 Flu Test and made by Arbor Vita Corporation, based in Sunnyvale, California, uses nose or throat swabs taken from patients who have flu symptoms. It takes less than 40 minutes for the test to confirm if the NS1 protein is present in the sample.

NS1 is a specific protein that identifies the presence of the influenza A/H5N1 virus subtype. This is the strain that is mostly found in birds, but can also pass from birds to humans, usually by touching infected poultry, and of the flu strains that infect birds it is the deadliest to humans.

According to the World Health Organization, 412 confirmed cases have occured around the world, mostly in Asia and Northern Africa, and so far none in North America.

However, many experts predict that one day it will mutate into a form that passes from human to human and cause a worldwide pandemic.

Currently approved tests for this flu subtype take up to three or four hours to produce a result.

Director of the FDA's Center for Devices and Radiological Health, Dr Daniel G. Schultz said the new test was an important tool to quickly identify emerging infections and reduce exposure to large populations.

"The clearance of this test represents a major step toward protecting the public from the threat of pandemic flu," he added.

The FDA reviewed evidence from clinical studies where the new test correctly identified the absence of infection in more than 700 specimens. It also correctly detected the presence of the A/H5N1 strain in 24 specimens.

The test manufacturer said in a statement reported by Scientific American yesterday that they had not yet set a price for the test, and although not yet approved in other countries they expected them to follow suit.

Sources: FDA, Scientific American.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
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