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FDA Approves Test for West Nile Virus in Blood Donors

Test detects virus shortly after infection in donor blood, cells, tissues and organs

TUESDAY, Sept. 4 (HealthDay News) -- The U.S. Food and Drug Administration has approved an additional test that can detect the West Nile virus in donated blood, cells and other tissues shortly after infection. The cobas TaqScreen WNV test, which is made by Roche Molecular Systems Inc. of Pleasanton, Calif., is the second such test to be approved.

As of late August, 58 cases of West Nile virus-infected donors have been reported to the U.S. Centers for Disease Control and Prevention for 2007. Overall, an estimated 1 million to 3 million cases of West Nile infection have occurred in the United States between 1999 and 2004, and the virus is endemic in nearly every state.

The test, which is not approved for use on cord blood, detects viral genetic material in whole blood, blood components and other tissues obtained from living donors or from plasma specimens obtained from organ donors when the heart is still beating. The test is not intended for use in the diagnosis of infection.

"This action is the culmination of the dedicated efforts of FDA, our sister agencies, blood establishments, and manufacturers to bring donor screening tests to market for this increasingly common virus," said Jesse L. Goodman, M.D., M.P.H., director of the FDA's Center for Biologics Evaluation and Research, in a statement. "As a result, blood centers and hospitals now have a choice of two FDA-approved tests to screen for West Nile virus in donated blood and organs."

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