Originally created 12/02/05

FDA approves test for screening West Nile virus

WASHINGTON - The Food and Drug Administration said Thursday it has approved the first test to screen blood, organ and tissue donations for West Nile virus.

The test has been widely used since 2003 at blood banks on an experimental basis. The FDA's action Thursday does not appear to significantly widen the test's availability. But it may improve testing of organ donations for the disease, an FDA spokeswoman said.

The test, the Procleix WNV Assay, was developed by Gen-Probe Inc. and is marketed by Chiron Corporation.

Since it was introduced, U.S. blood banks have detected and removed 1,600 donations infected with West Nile. At least 30 people caught West Nile from infected blood transfusions, and nine died, the FDA said.

The virus, first detected in the United States in 1999, is normally transmitted to humans by mosquito bites. It has caused at least 762 deaths since 2002, when it was discovered it could also be transmitted through blood transfusions.

Most infected people never get sick, but about 20 percent suffer flu-like symptoms. Fewer than 1 percent become severely ill; some people have a potentially fatal inflammation of the brain, membranes of the brain or spinal cord.

The FDA, in a statement, praised the speed in which the test was developed, distributed and approved.

Other laboratory tests are already available for testing if an individual has contracted the virus.


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