Nucleic Acid Test Screens Blood and Organ Donors for West Nile Virus

An automated nucleic acid test detects whether donated blood and organs have been infected with West Nile Virus (WNV) even before the donor's body has begun to produce antibodies against the virus. The test is expected to improve the safety of donated blood and organs.

Called the cobas TaqScreen WNV test, it detects the virus in plasma specimens from human donors of whole blood and blood components (plasma, red, or white cells, platelets) and living donors of cells, reproductive cells, and other tissues. It is also intended for use in testing plasma specimens of organ donors when specimens are obtained while the donor's heart is still beating. The test is not intended for use on samples of cord blood or as an aid in the diagnosis of WNV infection.

Manufactured by Roche Molecular Systems, Inc. (Pleasanton, CA, USA), the cobas TaqScreen WNV test is the second test to be approved by the U.S. Food and Drug Administration (FDA; Rockville, MD, USA) for detection of West Nile virus (WNV) in blood and organs.

"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 FDA's Center for Biologics Evaluation and Research. "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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Roche Molecular Systems
U.S. Food and Drug Administration