Diagnosis
In December 2005, the Food and Drug Administration (FDA) approved the Procleix West Nile Virus (WNV) Assay for the direct detection of viral nucleic acid in donors of whole blood and blood components, tissues, and organs. It can be used to screen organ donors whose heart is still beating as well as cadaveric (non-heart-beating) donors.
In March 2007, FDA approved the ProcleixTIGRIS system, the first fully automated WNV nucleic acid test for screening blood, tissues, and organs. The ProcleixWNV screening tests are manufactured by Gen-Probe Inc., and marketed by Chiron Corp.
In August 2007, FDA approved a biologics license application for another automated WNV nucleic acid test (cobas TaqScreen WNV Test) manufactured by Roche Molecular Systems Inc., for the same indication. It is noteworthy that neither the Procleix WNV screening tests nor the cobas TaqScreen WNV Test are intended for use on cord blood specimens or as an aid in diagnosing WNV infection.