cobas® WNV for use on cobas® 6800 and cobas® 8800 Systems is a qualitative in vitro nucleic acid screening test for the direct detection of West Nile virus (WNV) RNA in human plasma.
This test is intended for use to screen donor samples for WNV RNA in plasma samples from individual human donors, including donors of whole blood and blood components, as well as other living donors. This test is also intended for use to screen organ and tissue donors when donor samples are obtained while the donor’s heart is still beatingusing plasma or from cadaveric (non-heart beating) donorsusing plasma and serum.
Plasma from all donors may be screened as individual samples. For donations of whole blood and blood components, plasma samples may be tested individually or in pools comprised of not more than six individual samples. For all other donors, samples may only be screened as individual samples.
For donations from cadaveric (non-heart-beating) organ and tissue donors, samples may only be screened as individual samples.
This test is not intended for use as an aid in diagnosis of WNV infection.
This test is not intended for use on samples of cord blood.