Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Zika Virus Screening Test

FDA news release; 2017 Oct 5

The FDA has approved the cobas Zika test, the first test for screening Zika virus in blood donations. It is a qualitative nucleic acid test for the detection of Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole blood and blood components, and from living organ donors.

The test’s clinical specificity was evaluated by testing individual samples from blood donations at 5 external laboratory sites, resulting in clinical specificity of >99%.

The cobas Zika test is intended for use by blood collection establishments to detect Zika virus in blood donations, not for individual diagnosis of Zika virus infection. It is intended for use on the fully automated cobas 6800 and cobas 8800 systems, manufactured by Roche Molecular Systems, Inc.


US Food and Drug Administration. FDA approves first test for screening Zika virus in blood donations. FDA Web site. October 5, 2017. Accessed October 9, 2017.