The cobas® TaqScreen West Nile Virus Test, for use with the cobas s 201 system, is a qualitative in vitro test for the direct detection of West Nile Virus (WNV) RNA in human plasma.
This test is intended as a donor screening test to detect WNV RNA in plasma specimens from individual human donors, including donors of whole blood and blood components and other living donors. This test is also intended for use in testing plasma specimens to screen individual organ donors when specimens are obtained while the donor’s heart is still beating and in testing blood specimens from cadaveric (non-heart-beating) donors. This test is not intended for use on samples of cord blood.
Plasma from all donors may be screened as individual specimens. For donations of whole blood and blood components, plasma specimens may be tested in pools comprised of not more than six equal aliquots of individual specimens. For donations from cadaveric (non-heart-beating) organ and tissue donors, specimens may only be screened as individual specimens. This test is not intended for use as an aid in diagnosis.