GESTIÓN EN SALUD PÚBLICA: FDA In Brief > FDA announces revised guidance on the testing of donated blood and blood components for Zika virus

miércoles, 11 de julio de 2018

FDA In Brief > FDA announces revised guidance on the testing of donated blood and blood components for Zika virus

FDA In Brief > FDA announces revised guidance on the testing of donated blood and blood components for Zika virus

U.S. Food and Drug Administration - Medical Countermeasures Initiative Update

U.S. Food and Drug Administration - Medical Countermeasures Initiative Update

An FDA scientist works with blood in a laboratory

Revised Zika virus guidance for blood collection establishments

FDA announces revised guidance on the testing of donated blood and blood components

FDA has revised recommendations for testing blood donations for the Zika virus. 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. Read the full statement (July 6, 2018)

In related news, on July 5, 2018, FDA approved the Procleix Zika Virus Assay, manufactured by Grifols Diagnostics Solutions, Inc. The Procleix Zika Virus Assay is a qualitative nucleic acid test for the detection of Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole blood and blood components for transfusion. The assay is intended for use by blood collection establishments to detect Zika virus in blood donations. It is not intended for use as an aid in the diagnosis of Zika virus infection. For more information, see the approval letter (PDF, 41.2 KB).