FDA Approves Check to Display screen Donated Blood for Zika

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By Mary Elizabeth Dallas

HealthDay Reporter

FRIDAY, Oct. 6, 2017 (HealthDay Information) — The U.S. Meals and Drug Administration has authorised a brand new check — referred to as the cobas Zika check — to display donated blood for the Zika virus.

“Right this moment’s motion represents the primary approval of a Zika virus detection check to be used with screening the nation’s blood provide,” Dr. Peter Marks stated Thursday in an company information launch. Marks is director of the FDA’s Middle for Biologics Analysis and Analysis.

“Screening blood donations for the Zika virus is important to stopping contaminated donations from getting into the U.S. blood provide. Right this moment’s approval is the results of a dedication by the producer to work quickly and collaboratively with the FDA and the blood assortment business to answer a public well being disaster, and make sure the security of blood within the U.S. and its territories.”

Zika is unfold primarily by mosquitoes carrying the virus. It can be transmitted by sexual contact or blood transfusions.

In August of final yr, the FDA suggested all states to display all donated blood and blood merchandise with an experimental screening check accessible below an investigational new drug (IND) utility.

An IND permits the FDA to authorize use of an experimental drug in emergency conditions. The FDA really useful that an experimental Zika screening check be used till an authorised check turned out there.

A number of blood assortment facilities opted to make use of the cobas Zika check, which is made by Roche Molecular Methods.

Outcomes from these screenings together with research performed by Roche confirmed the check is an efficient solution to display donated blood for the virus. 5 completely different labs discovered the check precisely recognized 99 p.c of all contaminated blood samples.

Zika may cause devastating beginning defects in infants whose moms are contaminated with the virus whereas pregnant. The commonest of those is microcephaly, a situation through which the child’s head and mind is small and underdeveloped. 1000’s of infants in Brazil had been born with catastrophic neurological defects linked to the virus when the Zika outbreak there was at its top in 2015 and 2016.

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