FDA Approves Zika Virus Blood Screening Test

FDA officials have approved the first test for screening Zika virus in blood donations. The test is intended for use by blood collection establishments and not for individual diagnosis of infection.

The cobas Zika test 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, as well as from living organ donors.

In August 2016, the FDA issued a final guidance document recommending that all states and territories screen individual units of whole blood and blood components with an investigational blood screening test available under an investigational new drug (IND) application, or a licensed (approved) test when available.

The approval is based on the use of cobas Zika test under IND. The data collected from this testing, along with data from additional studies performed by the manufacturer, demonstrated that the test is an effective way to screen blood donors for the Zika virus infection. The test demonstrated clinical specificity of more than 99% in tests of individual samples from blood donations at 5 external laboratory sites.

The cobas Zika test is intended for use on the fully automated cobas 6800 and cobas 8800 systems, which are manufactured by Roche Molecular Systems, Inc.

Reference

FDA approves first test for screening Zika virus in blood donations [news release]. FDA. October 5, 2017. fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm579313.htm. Accessed October 5, 2017.