FDA Approves Test to Detect Zika Virus in Blood Donations

James Radke

The U.S. Food and Drug Administration (FDA) approved the cobas Zika test to detect Zika virus RNA in donor blood samples.

The test can be used by the cobas 6800 and cobas 8800 systems manufactured by Roche Molecular Systems, Inc and is intended for blood collection establishments to detect the Zika virus in blood donations. The test is not intended to be used to diagnose the Zika virus in individuals.

Per the FDA: "Today’s action represents the first approval of a Zika virus detection test for use with screening the nation’s blood supply," said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. "Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply. 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 U.S. and its territories."

Zika virus is transmitted primarily by the Aedes mosquito, but it can also be spread via sexual contact and blood donations. In most cases, people infected with the virus will never have any symptoms but some may experience fever, arthralgia, maculopapular rash, and conjunctivitis. The major concern with the zika virus is for those who are pregnant or thinking of becoming pregnant, as Zika infections can cause serious birth defects (e.g., microcephaly) and is associated with other adverse pregnancy outcomes.
Most cases of Zika infection in the United States are travel related but locally transmitted cases of Zika virus have been observed in Southern Florida and Texas. 

The approval of the cobas Zika test is largely a formality since it has been used by several blood collection agencies as part of an investigational new drug (IND) from which data was used to gain its approval.

The test’s clinical specificity was calculated to be over 99%.

According to the latest statistics from the Centers for Disease Control and Prevention (CDC), there have been 5530 symptomatic Zika virus cases in the United States reported between January 1, 2015 to October 4, 2017. Of those, 5,255 were travel related, 255 were through a local mosquito transmission, 48 through sexual transmission, 1 through unknown means, and 1 via laboratory transmission (i.e., blood donation).

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