America’s blood supply is better protected from the Zika virus, now that FDA has approved the first test designed to detect the virus in blood donations.
The cobas Zika test from Roche has already been used by several U.S. blood collection establishments under an investigational new drug application (IND). The test can also screen for the virus RNA in specimens collected from living organ donors.
“Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply,” said Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research.
Marks said the approval is the result of Roche working rapidly and collaboratively with FDA and the blood collection industry to respond to the Zika outbreak, which became a public health crisis last year. In an August 2016 guidance document, the agency recommended that all states and U.S. territories screen individual units of whole blood and blood components with an investigational blood screening test available under an IND application until there was a commercially approved test on the market.
The test’s clinical specificity was evaluated by testing individual samples from blood donations at five external laboratory sites, resulting in clinical specificity of more than 99%.
The Zika virus is transmitted primarily by mosquitos (Aedes aegypti), but it can also be spread through blood transfusion and sexual contact. Although most people infected with Zika virus do not develop symptoms, when symptoms do occur they may include fever, arthralgia (joint pain), maculopapular rash (red area with small bumps), and conjunctivitis (red, irritated eyes). In addition, Zika virus infection can cause a serious neurological disease in adults, and infection during pregnancy can cause serious birth defects.
The cobas Zika test is intended for use on Roche’s fully automated cobas 6800/8800 systems. According to Roland Diggelmann, CEO of Roche Diagnostics, the test has been used under the IND protocol to screen more than 4 million blood donations from the United States and Puerto Rico.
“This broad testing has helped to identify and remove over 450 potentially infectious donations from the blood supply, a significant achievement in the rapid response to this global health emergency,” Diggelmann said.
Roche said it first deployed the test last year in Puerto Rico under the IND protocol, which enabled the reinstatement of the blood services in the territory after concerns over the high rates of infection locally posed a significant threat to the blood supply. By the end of 2016, expanded deployment for the test supported screening efforts throughout the country.
The cobas Zika test is a qualitative in vitro nucleic acid screening test for the direct detection of Zika virus RNA in plasma specimens from individual blood human donors, the company noted.