FDA confirms Zika Blood Test

OCTOBER 05, 2017Kevin KunzmannThe America FDA (FDA) confirmed a qualitative nucleic acid Analysis which is designed to announce Zika RNA in individual donor plasma specimens.The cobas Zika Analysis works to announce the virus in volunteer donors of whole blood & blood components, as well as from living organ donors. Blood collection establishments going to be enable to of Utilize the Analysis to announce Zika in blood donations — however not for individually diagnosing Zika infection.Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation & Research, said this was the premier FDA consent of such a revelation Analysis for screening national blood supplies."Screening blood donations for the Zika is critical to protecting infective donations from entering the United States blood supply," Marks said. "The Zika virus, primarily transmitted out of mosquitos, could too spread out of blood transfusion & sexual contact. In information gathered from the uses, as well as extra industrialist studies, the cobas Zika Analysis evidenced effective. It returned a clinical specifity of 99%.As portion of the fully automated cobas 6800 & cobas 8800 systems, the Analysis is manufactured with Roche Molecular Systems, Inc.


Researchers protect Zika In Monkeys, wish To Help Pregnant Women

A team of investigators has protected Zika contagion in monkeys —and they wish the Fresh approach can be developed for Utilize in pregnant women. The small experimental experience found which monkeys given a cocktail of known Zika antibodies—special proteins the immune system makes to stop a virus—did not develop Zika after they were exposed to the virus. LISTEN: investigators stop Zika contagion in monkeysAt the peak of final year's Zika outbreak, 1 of Watkins' colleagues, Dr. Myrna Bonaldo at the Oswaldo Cruz Institute in Brazil, isolated an especially potent strain of the virus. Then they exposed them, along by 4 monkeys which didn't get the cocktail, to the additional virulent Zika strain from the pregnant woman's urine. Watkins tells which it willl take further study & funding, however the curing can be availiable for pregnant ladies in 2 to 3 years.

Researchers Prevent Zika Virus In Monkeys, Hope To Help Pregnant Women

FDA confirms Zika Blood Screening Test

as informed in 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
Comments