The Food and Drug Administration (FDA) has approved Roche’s cobas Zika test, a qualitative test that detects Zika virus RNA in plasma specimens obtained from donors of whole blood and blood components, as well as from living organ donors. It is the first FDA-approved test intended for use by blood collection establishments to detect Zika virus in blood donations, and not for the individual diagnosis of Zika virus infection.
In August 2016, FDA issued a final guidance document recommending that all U.S. states and territories screen individual units of whole blood and blood components with a Zika test available under an investigational new drug (IND) application until an approved test came on the market. Therefore, in compliance with this guidance, several blood collection establishments have already been using the cobas Zika test under IND. FDA used the data collected from this testing and additional studies performed by Roche to demonstrate that the cobas Zika test is an effective method for screening blood donors for Zika virus infection. Specifically, using individual samples from blood donations at five external laboratory sites, the agency determined that the test exhibits a clinical specificity greater than 99%.