FDA Approves Second West Nile Screening Test for Donated Blood and Organs

The FDA announced approval of a second test for the detection of West Nile virus (WNV) in blood and organs, manufactured by Roche Molecular Systems.

The cobas TaqScreen WNV test is an automated test to detect the genetic material of the virus itself early in the infection. Such nucleic acid testing improves safety, detecting whether donated blood and organs have been infected even before the donor’s body has begun to produce antibodies against the virus.

The cobas TaqScreen WNV test is approved for the detection of 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.

Approval comes as FDA is preparing guidance on the use of licensed WNV screening tests for blood donors, the agency said.