Search
User Profile
Change
Select your user profile

cobas ® Zika test

Zika

US FDA Approved donor screening test for Zika virus

The cobas®  Zika test, for use on the cobas® 68/8800 System, is a qualitative real-time PCR test for Zika virus (ZIKV).

Features and benefits

  • Detects major serotypes of virus (serotypes 1-4)
  • Ready-to-use reagents - no thawing, pouring or mixing
  • Stabilized real-time PCR reagents do not require calibration
  • Full-process internal control helps ensure result integrity
  • cobas® Zika Control Kit provides true external positive controls that have no effect on result calculation
  • Can be run simulatanouesly with other assays on the cobas® 68/8800 Systems
Contact Us
Intended use

Intended use

The cobas® Zika test, for use on cobas® 6800 and cobas® 8800 Systems, is a qualitative in vitro nucleic acid test for the direct detection of Zika virus RNA in human plasma.

The 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.

This 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 bodily fliuds.

This test is not intended for use on samples of cord blood.

...
    ...