News | August 26, 2016

FDA Calls for Zika Virus Testing for All Donated Blood in the United States

August 26, 2016 — As a further safety measure against the emerging Zika virus outbreak, the U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.
“There is still much uncertainty regarding the nature and extent of Zika virus transmission,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “At this time, the recommendation for testing the entire blood supply will help ensure that safe blood is available for all individuals who might need transfusion.”

Read the article "Imaging Zika Virus — Radiologic Assessment and Tracking of the Disease."

The FDA first issued guidance on Feb. 16 recommending that only areas with active Zika virus transmission screen donated Whole Blood and blood components for Zika virus, use pathogen-reduction devices, or halt blood collection and obtain Whole Blood and blood components from areas of the U.S. without active virus transmission. All areas with active transmission in the U.S. are currently in compliance with this guidance. The revised guidance announced today recommends that all states and U.S. territories screen individual units of donated Whole Blood and blood components with a blood screening test authorized for use by the FDA under an investigational new drug (IND) application, or a licensed test when available. Alternatively, an FDA-approved pathogen-reduction device may be used for plasma and certain platelet products.

The FDA is updating its guidance after careful consideration of all available scientific evidence, consultation with other public health agencies, and taking into consideration the potential serious health consequences of Zika virus infection to pregnant women and children born to women exposed to Zika virus during pregnancy. Testing of donated blood is already underway in Florida and Puerto Rico, as well as in other areas, and it has shown to be beneficial in identifying donations infected with Zika virus. Expanded testing will continue to reduce the risk for transmission of Zika virus through the U.S. blood supply and will be in effect until the risk of transfusion transmission of Zika virus is reduced.

Zika virus is transmitted primarily by the Aedes mosquito. Zika virus can also be spread by sexual contact. Although 4 out of 5 people infected with Zika virus never 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 during pregnancy can cause serious birth defects and is associated with other adverse pregnancy outcomes.

“As new scientific and epidemiological information regarding Zika virus has become available, it’s clear that additional precautionary measures are necessary,” said Luciana Borio, M.D., the FDA’s acting chief scientist. “We are issuing revised guidance for immediate implementation in order to help maintain the safety of the U.S. blood supply.”

The first local or non-travel related transmission of Zika virus in the U.S. by mosquitoes was reported from Puerto Rico in December 2015; and soon thereafter, local transmission was reported in American Samoa and the U.S. Virgin Islands. In July 2016, the first cases of local or non-travel related transmission of Zika virus in the continental U.S. were reported in Miami-Dade County, Florida.

In addition to protecting the nation’s blood supply, the FDA works to protect the safety of our nation’s supply of human cells, tissues, and cellular and tissue-based products; supports the development and availability of diagnostic tests that may be useful for identifying the presence of or prior exposure to the Zika virus; works with commercial and government developers to advance the development of investigational vaccines and therapeutics; and monitors for fraudulent products and false product claims related the Zika virus.

For more information: www.cdc.gov/zika/intheus/what-to-do.html

Related Content

Amazon Comprehend Medical Brings Medical Language Processing to Healthcare
News | Artificial Intelligence | February 15, 2019
Amazon recently announced Amazon Comprehend Medical, a new HIPAA-eligible machine learning service that allows...
Study Assesses Risk of MRI Exams for Patients With Tattoos
News | Magnetic Resonance Imaging (MRI) | February 01, 2019
A new European study concluded that magnetic resonance imaging (MRI) exams pose little risk for people with tattoos,...
Stereotactic Radiotherapy Improves Long-Term Survival in Stage-IV Cancers
News | Stereotactic Body Radiation Therapy (SBRT) | January 31, 2019
The first report from a phase II, multi-center clinical trial indicates stereotactic radiation can extend long-term...
ImaginAb Enrolls First Patient in Phase II PET Agent Clinical Trial
News | Radiopharmaceuticals and Tracers | January 30, 2019
ImaginAb Inc. announced the enrollment of the first patient in the Phase II clinical trial of the company’s CD8+ T Cell...
Artificial Intelligence Research Receives RSNA Margulis Award
News | Digital Radiography (DR) | January 28, 2019
The Radiological Society of North America (RSNA) presented its seventh Alexander R. Margulis Award for Scientific...
 Artificial Intelligence Shows Potential for Triaging Chest X-rays
News | Digital Radiography (DR) | January 23, 2019
An artificial intelligence (AI) system can interpret and prioritize abnormal chest X-rays with critical findings,...
Novel Technique May Significantly Reduce Breast Biopsies
News | Breast Biopsy Systems | January 17, 2019
A novel technique that uses mammography to determine the biological tissue composition of a tumor could help reduce...
Digital Mammography Increases Breast Cancer Detection
News | Mammography | January 16, 2019
The shift from film to digital mammography increased the detection of breast cancer by 14 percent overall in the United...
Artificial Intelligence Used in Clinical Practice to Measure Breast Density
News | Artificial Intelligence | January 15, 2019
An artificial intelligence (AI) algorithm measures breast density at the level of an experienced mammographer,...