Guidance for Industry: Transmission Risk of West Nile Virus from Living Donors of Cells and Tissues

In May the FDA published an update of their Guidance for Industry "Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)". The new guidance was published in September 2016 to supersede the draft guidance from 2015 (we reported under "Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus").

A correction has been made to this guidance - Under section III.A.1, the “Note” has been reformatted as follows:

"In the case of a repeat semen donor from whom a specimen has already been collected and tested, and for whom retesting is required under § 1271.85(d), you are not required to collect a donor specimen at the time of each donation (§ 1271.80(b)(2)). However, you should collect a specimen for WNV NAT testing at the time of (or within 7 days before or after) the first donation that is recovered within the June 1st through October 31st testing period, even if an earlier specimen was already collected and tested.
Due to the increased potential for donors, to contract WNV infection from June 1st through October 31st, establishments may want to consider collecting a specimen for WNV NAT testing at the time of (or within 7 days before or after) each donation made during this time period. Although this additional testing for subsequent donations is not required, any reactive results must be considered when making a donor eligibility determination."

For more information about the content of the guidance document please read the Guidence for Industry "Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)".

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