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FDA Revises Zika Virus Screening Guidance, Recommends Pooled Testing of Blood

NEW YORK (GenomeWeb) – The US Food and Drug Administration said today that it has revised its recommendations for testing blood donations for the Zika virus. In a revised final guidance, the agency said that pooled testing of donations using a screening test that it has licensed is a sufficient method for complying with its testing regulations and effectively reducing the risk of Zika virus transmission.

The revised guidance replaces a guidance announced in August 2016 that recommended universal nucleic acid testing for Zika virus of individual units of blood donated in US states and territories.

"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," Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement. "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."

The new approach is usually more cost effective and less burdensome for blood establishments, he said, adding that 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."

Following outbreaks of the Zika virus, US blood centers in 2016 began implementing individual donation nucleic acid testing under investigational new drug applications. They used the Roche Cobas or Grifols Procleix Zika virus assays.

In May this year, the FDA approved an additional claim for Roche's Cobas Zika test for use on the Cobas 6800 and 8800 PCR systems that enables streamlined screening of multiple individual blood or plasma donations that have been pooled together. Cobas Zika is a qualitative in vitro nucleic acid screening test for the direct detection of Zika virus RNA in plasma specimens from individual human blood donors. It enables blood services to ensure that potentially infected blood units are not made available for transfusion

In an exception to pooled testing in its revised guidance, the FDA said that an increased risk of local mosquito-borne transmission of Zika virus in a specific geographic area would require individual donation testing in that location.

The overall change, announced in a revised guidance document entitled Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components, comes after careful consideration of all available scientific evidence, including consultation with other public health agencies, and following the recommendations of a December 2017 meeting of the Blood Products Advisory Committee, the agency added.