The cobas® Zika test for use on the cobas® 6800 and cobas® 8800 Systems is a qualitative in vitro nucleic acid screening test for the direct detection of Zika virus RNA in human plasma. This test is intended for use to screen donor samples for Zika virus RNA in plasma samples from individual human donors, including donors of whole blood and blood components, and 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 beating.
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 individual samples. The test is not intended for use as an aid in diagnosis of Zika virus infection. This test is not intended for use on samples of cord blood. This test is not intended for use on cadaveric blood specimens.