FDA confirms Roche Zika Assay for Blood Donation Screening

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FDA confirms Analysis to announce Zika in Blood Donations

OCTOBER 06, 2017James RadkeThe United States FDA (FDA) confirmed the cobas Zika Analysis to announce Zika RNA in donor blood samples.The Analysis could be used by the cobas 6800 & cobas 8800 systems manufactured by Roche Molecular Systems, Inc & is intended for blood collection establishments to announce the Zika in blood donations. The Analysis isn't intended to be used to diagnose the Zika in individuals.Per the FDA | "Today's action represents the premier consent of a Zika revelation Analysis for Utilize by screening the nation's blood supply," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation & Research. "Screening blood donations for the Zika is critical to protecting infective donations from entering the United States blood supply. "Zika virus is transmitted primarily by the Aedes mosquito, however it could too be spread via sexual contact & blood donations. In generality cases, people infective by the virus going to never have any Signs however some probably trial fever, arthralgia, maculopapular rash, & conjunctivitis.

FDA confirms Zika Blood Screening Test

referring to OCTOBER 06, 2017FDA officials have confirmed the premier Analysis for screening Zika in blood donations. The Analysis is intended for Utilize by blood collection establishments & not for individual diagnosis of infection.The cobas Zika Analysis is a qualitative nucleic acid Analysis for the revelation of Zika RNA in individual plasma specimens obtained from volunteer donors of whole blood & blood components, as well as from living organ donors.In August 2016, the Food and Drug Administration issued a last guidance document recommending that all states & districts Monitor individual units of whole blood & blood components by an investigational blood screening Analysis obtainable under an investigational Fresh drug (IND) application, or a licensed (approved) Analysis while available.The consent is based on the Utilize of cobas Zika Analysis under IND. The information gathered from this testing, along by information from extra researches performed by the manufacturer, demonstrated that the Analysis is an efficient method to Monitor blood donors for the Zika infection. The Analysis demonstrated clinical specificity of further than 99% in tests of individual samples from blood donations at five external lab sites.The cobas Zika Analysis is intended for Utilize on the fully automated cobas 6800 & cobas 8800 systems, that are manufactured by Roche Molecular Systems, Inc.FDA confirms premier Analysis for screening Zika in blood donations [news release]. Accessed October 5, 2017.

collected by :Sandra Alex