October 05, 2017
A test for screening donated blood for the Zika virus that was pressed into service on an experimental basis during last year's red-alert outbreak was approved today by the US Food and Drug Administration (FDA).
The cobas Zika test, made by Roche Molecular Systems, is a qualitative nucleic acid test that detects Zika virus RNA in plasma specimens taken from donated whole blood and blood components as well as living organ donors. It is designed to run on fully automated cobas 6800 and cobas 8800 molecular testing systems from Roche. As such, this Zika test is intended for blood collection establishments, not for clinicians who want to diagnose the infection in individuals, according to the FDA
"Today's approval is the result of a commitment by the manufacturer to work rapidly and collaboratively with the FDA and the blood collection industry to respond to a public health crisis and ensure the safety of blood in the US and its territories," said Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, in a news release.
In March 2016, when the Zika virus was spreading in the US territories of Puerto Rico and the US Virgin Islands, and poised to reach the US mainland, the FDA announced that it would allow the use of the still-experimental cobas Zika test for screening blood donations. In its announcement today, the agency said that the investigational use of the test, as well as additional studies by Roche, showed it to be effective in screening blood donations. Its clinical specificity exceeds 99%.
FDA OKs First Test to Screen Zika Virus in Donated Blood - Medscape - Oct 05, 2017.