The U.S. Food and Drug Administration today approved the Cobas Zika test, 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, and from living organ donors. It is intended for use by blood collection establishments to detect Zika virus in blood donations, not for the individual diagnosis of Zika virus infection.
The Zika virus is spread primarily by mosquitos (Aedes aegypti), but it can also be transmitted through blood transfusion and sexual contact. Zika virus most often causes no symptoms, but when symptoms do occur they may include fever, arthralgia, maculopapular rash, and conjunctivitis. It also causes a severe neurological disease in adults, and infection during pregnancy results in severe congenital disabilities.
This is the first approval of a Zika virus detection test to screen the U.S. blood supply. “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,” said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.
The FDA issued a final guidance document in August 2016. It suggests 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 an approved analysis when possible.
To follow the recommendations in the FDA's 2016 guidance document, several blood collection establishments used the cobas Zika test under IND to screen the donated blood units. The present study collected from those testings, and from additional investigations carried by the manufacturer, resulted that the cobas Zika test is a clinically useful test to screen blood donors for Zika virus infection. In order to evaluate the clinical specificity, the individual specimens from the blood donations were screened at five external laboratory sites, and they found more than 99% of clinical specificity.
The cobas Zika test is aimed for use on the fully automated cobas 6800 and cobas 8800 systems. The cobas Zika test, cobas 6800, and cobas 8800 systems are manufactured by Roche Molecular Systems, Inc.
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.