cobas® Zika test

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 Zika virus RNA in the plasma of donors of whole blood or blood components, organs or tissue. This qualitative blood screening assay is for use on the cobas® 6800/8800 Systems and can simultaneously detect Zika virus RNA, for use on the cobas® 6800/8800 Systems.

Features and benefits of the cobas® Zika

  • Ready-to-use reagents only require refrigeration – 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

Expertise, collaboration and rapid action result in the expedited development of a screening test to quickly address a public health emergency

When a large population is in the throes of a dangerous disease outbreak, when a public health emergency of international concern is issued, and there is a dire need to develop a diagnostic test, speed is everything.

 

The world was stunned in 2015 by the outbreak of Zika in Brazil. Within months, thousands of cases of microcephaly incidence were reported in Brazil and a strong association between microcephaly and Zika virus was established.1 The World Health Organization declared Zika as a Public Health Emergency of International Concern. In the United States, the Food and Drug Administration (FDA) issued a Guidance prohibiting blood transfusion using blood collected in Zika virus active areas.2 The FDA asked diagnostic companies to evaluate feasibility and timeline for a diagnostic test to look for Zika virus in the blood. With extraordinary coordination and collaboration with different organizations such as the FDA, Centers for Disease Control and Prevention, and various blood collection agencies, and utilizing its expertise in assay design and automation, Roche responded to the FDA’s call. The cobas® Zika test was developed, approved and made available for use under an Investigational New Drug application (IND) within 10 weeks of the FDA guidance.3 In October 2017, after clinical validation and BLA submission, the FDA approved Roche cobas® Zika (IVD) test for use on the cobas® 6800/8800 Systems.4 The cobas® Zika test was the first commercially available test for the detection of the Zika virus RNA in samples of human plasma intended for use in screening blood donations.4

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

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.