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Blood in bags and vials
Photo by Daniel Gay

The US Food and Drug Administration (FDA) has released a revised guidance on testing donated blood and blood components for Zika virus.

The revised guidance states that it is no longer necessary to screen every donation individually.

Pooled donations can be tested for Zika virus in most cases, although, in areas where there is an increased risk of mosquito-borne transmission of Zika, donations should be tested individually.

The FDA said the revised guidance is a result of careful consideration of all available scientific evidence, including consultation with other public health agencies, and following the recommendations of the December 2017 meeting of the Blood Products Advisory Committee.

“When Zika virus first emerged, the unknown course of the epidemic and the observed severe effects from the disease indicated that individual donor testing was needed to ensure the continued safety of the blood supply,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

“Now, given the significant decrease in cases of Zika virus infection in the US and its territories, we are moving away from testing each individual donation to testing pooled donations. This is usually more cost-effective and less burdensome for blood establishments. However, the FDA will continue to monitor the situation closely, and as appropriate, reconsider what measures are needed to maintain the safety of the blood supply.”

The FDA’s revised guidance replaces the August 2016 guidance, which recommended universal nucleic acid testing of individual units of blood donated in US states and territories.

The revised guidance explains that, to comply with applicable testing regulations, blood establishments must continue to test all donated whole blood and blood components for Zika virus using a nucleic acid test.

However, in many cases, pooled testing of donations using an FDA-licensed screening test is a sufficient method for complying with these regulations. If there is an increased risk of local mosquito-borne transmission of Zika virus in a specific area, donations should be tested individually.

As an alternative to pooled or individual testing, blood establishments can use an FDA-approved pathogen-reduction device for plasma and certain platelet products.

The FDA said these recommendations will continue to ensure the safety of the US blood supply by reducing the risk of Zika virus transmission while also reducing the burden of testing for blood establishments.


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