cobas® Zika

Real-time PCR based donor screening test for Zika virus

Zika

First commercially available FDA-approved donor screening test in the U.S. for Zika virus

Safe donor blood. Safer blood supply.

The cobas® Zika test is a real-time PCR-based nucleic acid test (NAT) for the detection of the Zika virus RNA in samples of human plasma intended for use in screening blood donations. This qualitative blood screening assay is for use on the cobas® 6800/8800 Systems.

Features and benefits of the cobas® Zika

  • Ready-to-use reagents – no thawing, pouring or mixing
  • Stabilized real-time PCR reagents – no calibration required
  • Full-process internal control – result integrity
  • cobas® Zika Control Kit as true external positive controls with no effect on result calculation
  • Ability to be run simultaneously with other assays on the cobas® 6800/8800 Systems
Intended use

Intended use

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 not more than six 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 other body fluids. This test is not intended for use on samples of cord blood.

Registration status

US-IVD