The FDA announced today that the United States will no longer test individual blood donations for the presence of Zika virus, which it has done for the past 2 years.
Instead, under new guidance, the FDA said blood establishments can test pooled donations for the presence of the virus “unless there is an increased risk of local mosquito-borne transmission of Zika virus in a specific geographic area that would trigger individual donation testing in that location.”
Peter Marks, MD, PhD, who heads the FDA’s Center for Biologics Evaluation and Research, said the change was in response to a significant decrease in the number of Zika virus cases in the U.S.
“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. Now, given the significant decrease in cases of Zika virus infection in the U.S. and its territories, we are moving away from testing each individual donation to testing pooled donations,” Marks said in a statement.
The U.S. has tested individual blood donations for Zika virus since August 2016.
Source: James Gathany
“This is usually more cost effective and less burdensome for blood establishments,” he continued. “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.”
Since 2016, the FDA had recommended that all donated whole blood and blood components in the U.S. be screened for Zika. In May, researchers questioned the value of the policy after finding that it cost around $5.3 million for each positive test. – by Gerard Gallagher
FDA. Revised recommendations for reducing the risk of Zika virus transmission by blood and blood components. 2018. https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM518213.pdf. Accessed July 6, 2018.
Disclosure: Marks works for the FDA.