August 29, 2007

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FDA approves second West Nile Virus test

The U.S. Food and Drug Administration has approved a second screening test for West Nile Virus disease for use in donated blood and organs.

The cobas TaqScreen WNV test is an automated test that's able to detect the genetic material of the virus itself early during the infection process, the FDA said. The nucleic acid testing detects whether donated blood and organs have been infected, even if the donor's body hasn't begun to produce antibodies against the virus.

West Nile Virus is most often transmitted to humans by mosquitoes but it can also be transmitted through blood transfusion or organ transplantation from infected donors.

The approval means blood centers and hospitals will have a choice of two FDA-approved tests, said Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research.

The newly approved test is manufactured by Roche Molecular Systems Inc. of Pleasanton, Calif.

Copyright 2007 by United Press International

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